Data sharing is all over academic news now. We had Research Parasites, a noxious species of scientists who want to analyse others’ published data without granting its “owners” co-authorships and a certain control over the interpretations. Then there is a major battle between patients and clinicians about the release of the original data from the so-called PACE trial, originally published in The Lancet, which analysed medical efficiency and economic costs of different therapies for chronic fatigue syndrome/ myalgic encephalomyelitis (CFS/ME). Since the PACE study came out in 2011, the patients, but also a number of academic scientists, remained unconvinced of the published therapy recommendations and suspected a misinterpretation of data. The authors felt harassed and even threatened by the patients’ incessant demands. The relevant research institutions, the Queen Mary University London and the King’s College London, took the side of their clinicians and refused the release of data, using as argument the allegedly inappropriate nature of such requests and the privacy rights of trial participants.

Importantly, the data sharing requests always concerned anonymised patient data, where names and any other personal information of the trial participants was specifically deleted, to avoid any even approximate identification and breach of privacy. Yet even then, several attempts of patients as well as academics, to obtain the anonymised PACE trial data were converted by the universities from academic inquiries into the bureaucratic Freedom of Information Act (FOIA) requests, which were then repeatedly rejected. At the same time, some of the original PACE authors have been apparently somewhat critical of their original interpretations.

data sharing2

In 2012, a cost-effectiveness analysis of the PACE trial therapies was published in the open access journal PLOS One, where the authors by default had to agree “to make freely available any materials and information described in their publication that may be reasonably requested by others for the purpose of academic, non-commercial research”. James Coyne, professor of Health Psychology at the Dutch University Medical Center in Groningen, has since used this clause to demand the release of the published PACE data (Coyne is also an academic editor at PLOS One and writes a PLOS blog). His request was once again converted into a FOIA and turned down by King’s College London as being “vexatious” (just as Queen Mary University did before). The official letter to Coyne read:

“The university considers that there is a lack of value or serious purpose to your request. The university also considers that there is improper motive behind the request. The university considers that this request has caused and could further cause harassment and distress to staff”.

Nevertheless, PLOS One has issued an editorial notification saying:

“we are seeking further expert advice on the analyses reported in the article, and we will evaluate how the request for the data from this study relates to the policy that applies to the publication”.

Coyne, it seems, brings it in his blog post to the point:

“No one forced Peter White [lead author of PACE study,- LS] and colleagues to publish in an open access journal committed to data sharing, but by doing so they incurred an obligation. So, they should simply turn over the data”.

More recently, four tenured US-American biomedical scientists have approached Queen Mary University about the PACE data release. The university’s rejection of their FOIA was much more polite and cited as reason the “explicit guarantees to participants” regarding their data confidentiality.

The PACE trial case might become a key test for the Open Data movement in academia.

Most recently, an essay was published in Nature, authored by Dorothy Bishop, professor of Developmental Neuropsychology at the University of Oxford, and Stephan Lewandowsky, professor in Cognitive Psychology at the University of Bristol. The essay’s title was: “Research integrity: Don’t let transparency damage science”, many took it as general criticism of open science and data sharing. Except that it wasn’t. As I learned, the misleading title was actually designed by the Nature editors, who were possibly keen on creating some controversy and click-baiting or, who knows, maybe they even acted out of general editorial distrust to open data sharing. The Nature editors even employed a cartoon which seemingly compared data sharing advocates with treacherous knife-stabbers.

In fact, as both Bishop and Lewandowsky assured me, they both are strong proponents of data sharing (see this blog post by Bishop). Lewandowsky is also one of the authors of “The Peer Reviewers’ Openness Initiative” and had his own experience of “constantly being accused of not being transparent”.

The Nature essay briefly mentioned PACE trial, and in fact it also generally addressed the concerns of harassment and reputation damage, which were used as excuse by the PACE researchers and their universities as to not to release the trial’s data.

There apparently two main problems with any possible PACE data release. One is the complete breakdown of any reasonable communications between researchers and their critics, and the other is the uncertainty about what kind of consent the PACE trial participants originally gave to the PACE researchers regarding handling of their data.

Bishop comments that in the case of PACE that

“the discussion is infected by a complete breakdown of trust between CFS/ME researchers and their critics. This goes back years before PACE and includes attempts to stop PACE happening at all. Given that history, and others of our right-hand column ‘red flags‘ being ticked by some critics, it is not surprising that the PACE investigators doubt that they will get a fair evaluation from those demanding the data”.

The Oxford neuropsychologist then explained that, given to word limitation, she and Lewandosky were not able to elaborate on their suggestions on how to avoid such a “stalemate situation”, one such solution being:

“setting up a kind of ombudsman , i.e. an ‘honest broker’ who would be able to do statistical analyses from a neutral perspective. […] I don’t think the journals could do it – I’m not talking about someone to decide if data should be released, but rather a group who could agree what analyses needed doing and do them competently, in a buffer zone between researcher and critics. I am in very early discussions about a possibility of having some kind of unit with statistics expertise that would be dedicated to this, but we’d have to persuade someone to fund it. It’s possible that the uproar around PACE might just help this happen, as medical profession is concerned that nobody wants to research this topic in current atmosphere”.

In this regard, Simon Wessely, professor of Psychological Medicine at the King’s College London, indicated over Twitter that “a robust trusted independent system” is being set up at his university “because at the moment there is no trust”. This supposedly with the purpose of assuring proper confidentiality of the trial participants’ data.

Update 19.02.2016: Wessely has shared his views on data sharing and patient privacy in UK, which I refer in a comment below.

The King’s College’s press release from December 18th 2015 stated that they are

“currently seeking further ethical and scientific advice, as well as the advice of patients, on how best to provide independent decisions about appropriate access to relevant data”

Remarkably however, and bringing us back to the “research parasitism” debate, the PACE data was so far apparently available to any scientific collaborator.

This one can deduce from the press release by King’s College researchers:

“We have supplied requested, anonymised data to independent scientists, as part of normal research collaboration”.

In academia, collaboration generally equals co-authorship. This would mean, any PACE collaborator requiring the original trial data would in some way involve the original PACE authors in any follow-up research or evaluation. Whatever their collaborative effort may entail beyond data sharing, it would likely provide the PACE data “owners” co-authorships on all collaborative research publications. These automatic co-authorships (or their equivalent) were roughly what the “research parasites” editorial in the New England Journal of Medicine (NEJM) insisted upon.

I asked Bishop and Lewandowsky for their insights. Why can anonymised patients’ data be readily shared with any new collaborators, whom the original participants never even heard of back then when they signed their consent, yet it cannot be shared with any non-collaborating academics, who are interested in their own independent analysis of the published data?

It seems, the issue is basically the legalese of what exactly the patient participants of the PACE trial have signed their consent to.

Lewandowsky explained that in his field of psychology research, participant consent must include open data:

“The sharing must be governed by legal and ethical considerations: For example, some of my data can be found here, but you will note that some of those require an application. This is because under UK law, participants must declare their explicit consent to sharing for data to be freely available. If that consent was not given (in my case, because the studies were conducted either before this need was recognized or they were collected in Australia where laws are different), then data cannot be completely open. Likewise, there may be confidentiality issues involved, which I discuss here”.

Lewandowsky added:

“For medical data, things are far more complicated and nuanced”.

Bishop seemed quite concerned by the possibility that clinical research data may be shared with selected collaborators only, and not with a wider research community:

“If there are inconsistencies in how data-sharing is implemented, this would be problematic. We need to avoid situations where researchers are sole gate-keepers of access to data and refuse access to bona fide researchers who are critical of their work (assuming there are no ethical or legal reasons for refusal). The current data sharing guidelines of the MRC [British Medical Research Council, which also funded the PACE trial- LS] appear to be devised to handle this situation, by requiring independent oversight of requests for data, and having an appeal process when data requests are denied.”

However, in regard to studies without explicit patient participants’ consent to open data sharing, MRC guidelines are unclear on whether the data sharing with non-collaborating researchers is covered by the standard patients’ consent:

“For established studies, the extent to which ethics committees will approve broad consent for future new uses may be constrained by the consent(s) given by participants in the past, which may be rather vague or restrictive (e.g. “…not shared outside the research team”). For new sweeps of existing studies, and new studies, it should be reasonably straightforward to establish consent for sharing such that participants’ data are used to maximal good effect.”

Bishop then explained:

“In brief: for many years the consent form said something like “My data will be kept in a locked filing cabinet and not be available to anyone other than the research team. Then people realised that this was over-restrictive. There has been gradual change to encourage consent that allows for data-sharing.

The other thing is that trial participants would not, in general, give a blanket approval for their data to be used for research. They would have been given an information sheet that specified not just who would see the data, but what purposes it would be put to. More information here

So how should the situation with the lack of patients’ original consent be resolved?

Like Bishop, MRC guidelines recommend “independent advice and oversight”:

“The access governance process is subject to independent oversight of (a) external requests for data (and related materials, such human tissue and DNA, if appropriate); and (b) new investigation requests from within the study team for uses that are not already approved by MRC (or other relevant funder or sponsor) as part of the study’s research programme”.

Indeed, this is what apparently has been lacking in case of the PACE trial, where the two supposedly impartial universities, Queen Mary University and King’s College, have so far busied themselves by defending their clinical scientists from “harassment and distress” as well blocking all  “vexatious” requests of data sharing from independent non-collaborating researchers.

It is probable that a functional solution to sharing of PACE data might be found, likely with the help of some kind of “intermediary honest broker“ proposed by Bishop. If not, at least the PLOS One publication might have to be retracted, due to the lack of patient consent to data sharing. However, even if the anonymised PACE data will be finally shared also with non-collaborating academics for a purpose of precisely specified analysis, it is far from sure that all CFS/ME patients will be satisfied then. All actors are, to put it carefully, somewhat distrustful towards each other.

Update 8.02.2016, 20:20  Apparently, the original patient participant consent form of the PACE trial has been made public already

Update 16.02.2016: The anonymised patient data from the FINE trial on chronic fatigue syndrome therapies efficiencies, which is occasionally referred to as PACE sister trial, has been made publicly available as it was published in PLOS One in December 2015:

Data Availability: The authors have prepared a dataset that fulfills requirements in terms of anonymity and confidentiality of trial participants, and which contains only those variables which are relevant to the present study. Data are available as Supplementary Information”.

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Update 7.03.2016. As James Coyne informed me, PLOS One has issued an editorial note demanding that the PACE trial authors release anonymised patient data. Excerpt:

“We have now carefully assessed the study and sought advice from two editorial board members, who have provided guidance on the data necessary to replicate the cost-effectiveness analyses reported in the article, and thus we have established which data we would expect the authors to share in the context of the analyses presented in this PLOS ONEarticle. We have contacted the authors to request the release of the data, which include individual patient-level data underlying tables in the article”.

42 thoughts on “PACE trial and other clinical data sharing: patient privacy concerns and parasite paranoia

  1. Great summary. I’m sure it’s true that there is very little trust between the two sides, however I do think it is problematic to assume that those asking for FOI requests are also the same people doing other things that may be considered harassment. Does data sharing stop when some members of a community (or quite likely people not in a community but jumping on a band wagon) behave badly? Certainly the Information Commissioner doesn’t think so – it’s probably worth pointing out that the ICO has ordered the release of data from one of the requests,originally denied by QMUL. They have, however not complied and are instead, I believe taking the matter to the first tier tribunal. This issue is therefore still ongoing – at some expense I would imagine.

    Liked by 9 people

  2. What seems to be missing in all this discussion is the impact that not releasing data has on patients and treatments they are offered. PACE is a good example of this in that the protocols were rewritten to a huge extent even though the trial was not blinded. The worst example is perhaps the changes in the recovery thresholds which were reduced to a very low level based on bad statistics. So patients are naturally concerned that the information they are getting is not accurate.

    Shouldn’t patients getting accurate information be the main ethical driver in the case of medical research?

    In the piece on sharing data and red flags its all about academics and there are some very subjective red flags which boil down to expertise and what are major and minor errors. But it is written from the perspective of an academics concerns in an argument with a campaign group, Things are rarely that simple and most situations will be multiparty and somewhat less controlled,

    In the PACE case patients are unhappy about the reporting of the trial. I would raise three major issues
    1) The press coverage talked of ‘cures’ from exercise in a way that was very unsympathetic to patients and didn’t represent the results in the paper
    2) The protocol changes which were all likely to enhance the reported results. Patients have been denied access to the original protocol defined definitions.
    3) That the questionnaire results are largely meaningless when interventions were aimed at changing how patients felt about their symptoms. The more objective measures were dropped or not well reported.

    So in the view of many patients something has gone wrong in the science and its reporting. Yet the medical establishment and press has been vigorous in supporting PACE.

    How are patients meant to react. There is no mechanism for ‘outsiders’ to comment on science and ensure it is correctly reported. Academics were and largely still are uninterested or supportive of the PACE position of not publishing the protocol defined outcomes.

    So yes patients write letters to journals and they get published (according to QMUL that is harassment). They may go over the top on social media but there is no other mechanism.

    So when science isn’t self correcting but it is blatantly obvious to those outside that something is wrong what should they do. And this is where I think the main ethical outcome should be accurate information.

    Liked by 12 people

    1. Well worth reading David Tuller’s blog posts on Virology. For a quick summary of some of the problems: huge post-hoc changes to primary outcome measures, such that a patient score that would result in a patient being labelled “disabled” by the authors at the start of the study, the same score would now result in the label “recovered” at the end of the trial. They dropped the objective measures when they didn’t prove their pet theory of de-conditioning and false illness beliefs. In the trial, they gave patients a published newsletter telling them the treatments being studied had already been proven to work. They used a definition for recruitment of patients that the US government P2P report suggested should be retired because it is overly broad and will include patients with other illnesses (hardly any other researchers use it now, only those studying CFS as a behavioural illness – almost everyone else uses more modern and strict criteria to select their patients). Broke the declaration of Helsinki and did not tell patients that they worked for disability insurers advising on how to deny ME/CFS claims.

      Add to that the way they actively smear patients to discredit them, there’s really no wonder there has been a breakdown in trust and it’s clear who caused this to occur.

      Liked by 6 people

  3. The commitment of some researchers to open data often seems to hit a wall when specific situations arise: “Open data is good … (but only I should decide who is qualified to see it).” And that is just as bad as no open data at all, if everyone can decide to only release data to their friends and people who share the same beliefs about the illness and its trialed therapies.

    Is an “honest broker” ever necessary in science? Surely if the resulting critiques of contrary academics or the patient rabble are incorrect, that will be made apparent in the process of peer review or public commentary on the website of the relevant journals. No one sees every flaw, which exactly why open data is so important, and why it should include access for patient citizen-scientists, whose lack of formal training is compensated with a unique insight into the disease. Feelings might get hurt by having flaws politely exposed, but exposing those flaws is how science flourishes.

    But at a bare minimum, I dare say that in the case of the PACE trial, patients would require that the data be analyzed as specified in the protocol and the PACE team’s other preliminary documents. It’s what they were promised, after all.

    Liked by 7 people

  4. PACE author Peter White campaigning to exempt universities from the freedom of information act. If they succeed, they will never have to publish data they don’t want anyone to see.

    https://jcoynester.wordpress.com/2016/01/31/further-insights-into-the-war-against-data-sharing-the-science-media-centres-letter-writing-campaign-to-uk-parliament/

    The narrative of PACE authors being subject to harassment by a small number of troubled individuals is promoted precisely to justify such a radical change to the FOIA. The freedom of information requests are portrayed as harassment because there have been so many. Yet the FOIA reminds institutions that a large number of requests may simply imply large public interest rather than a campaign of harassment (therefore PACE authors insist the critics are a small number of troubled individuals. The PACE authors have never attempted to resolve this issue by giving the public the information being asked for.

    That skepticism over PACE is widespread among patients can be seen from a 11,800 signature strong petition to the Lancet, asking for misleading PACE claims to be retracted:
    http://my.meaction.net/petitions/pace-trial-needs-review-now

    I don’t believe that the issue is protecting patient privacy because freedom of information requests have been rejected for many different reasons. Even a very simple request for the values plotted on an already published graph was rejected as vexatious. (this data would consist of the means and standard deviations for 4 intervention groups at 4 assessment points: 32 numbers). Also, if the matter was only patient privacy, scientists interested in analyzing PACE data could be asked to sign a confidentiality agreement.

    Liked by 9 people

  5. Thanks for writing about this, a well written, well-balanced article.

    Since the PACE supporters began to lose control of this situation, when the outside scientific community came in and joined patients in demanding the data be released, there has been a change in tact. They know they are going to have to release the data at some point (though they continue to stall at every step). The new tactic is to talk about an independent broker, or some other system to restrict access to the data. It is damage limitation. But this is quite some jump in position, and hasn’t been justified: what reason is there to deny open data? This was a heavily publicly funded trial, which has a huge impact on patient treatment all over the world. The Information Commissioner has already found in favour of the data being released, rejecting QMUL’s arguments as unconvincing.

    I think it was Simon Wessely who first suggested it, and it’s worth noting that he is formally acknowledged in one of the PACE journal papers as having advised on the PACE trials design and execution.

    The other tactic used alongside this, which is nothing new, is to discredit patients and other critics, and saying that because of this breakdown in trust there needs to be a mediator to control the data analysis. Again, why? If critics were to see the data and raise issues with it, either those issues would be valid and the scientific community would reach consensus to agree with them that they are serious problems, or they would be dismissed as unimportant by the scientific community. That’s how science should work and critics of the trial welcome that. It is only the PACE supporters who dread it as right now everyone just has to take their word for everything. But as pointed out, there is no trust, so their word is not enough.

    Clearly the data needs to be released, it needs to be open to anyone to see, to comment on, and the study must stand or fall on it’s own merits.

    I think once the data is out, it will quickly become clear why the PACE supporters have fought every step of the way to keep the data secret.

    Liked by 6 people

  6. Thankyou for covering this issue with balance. There is some ambiguity over what exactly the PACE trial participants consented to. However, there are several important points worth adding:

    1) As the Information Commissioner concluded, individual patient data (IPD) is not regarded as personal data under the Freedom of Information Act or the Data Protection Act, as long as there is no significant risk of re-identification. Confidentiality guidelines in the UK typically allow the de-identification or anonymisation of such data without consent. Examples where anonymisation has failed typically involve factors that do not apply to the request that the Information Commissioner has supported. The FINE trial, sister to the PACE trial and both funded by the Medical Research Council, recently made IPD publicly available in PLOS One.

    2) There is a strong public interest in disclosure of IPD. Clearly there is a breakdown of trust. While the controversy over the interventions tested in the PACE trial began long before the results were published, much of the post-publication controversy stems from the major, (mostly) poorly or erroneously justified, post-trial deviations from the published trial protocol. Most of these changes appear to have occurred after the investigators were already familiar with the main outcomes data, and are suspected to have exaggerated the trial results by several fold. It is a serious red flag when innovators of an intervention are allowed to change the thresholds of clinical response and full recovery, after seeing the outcomes data and in a manner which greatly exaggerates the results. They still refuse to publish the results as pre-specified in the published trial protocol (March 2007).

    3) This controversy is not simply an academic curiosity; there are real world harms to patients by getting this wrong, particularly when authoritative but false claims of full “recovery” are made about a disabling illness with a poor prognosis and regarded as difficult to treat. Post-exertional symptoms and an activity ceiling are hallmarks of strictly defined ME and CFS (but not required or sufficiently measured in the PACE trial). The PACE trial interventions, CBT and GET, are presented as helping patients by challenging their (allegedly) unhelpful beliefs and (allegedly) maladaptive behaviours, and encouraging them to push beyond their perceived limits. Evidence from clinical trials strongly suggests that modest subjective improvements are self-reported for a small minority, but there are no meaningful improvements to objectively measured outcomes. However, false and widely promoted claims of a full “recovery”, based on questionably lax criteria (such as thresholds for normal fatigue and physical function that overlap with trial entry criteria for severe and disabling fatigue), expose patients to unrealistic expectations that will lead to harm and then blame when they fail to improve as expected. Patient surveys of real world experiences with CBT and GET outside clinical trials, universally report that a large proportion of patients experience adverse effects, with some reporting that CBT and especially GET worsened or destroyed their lives permanently.

    4) If Queen Mary University of London (QMUL) are now seeking the views of trial participants, about what to do in response to the requests for IPD, there is a risk that QMUL are presenting the situation to participants in a manner that strongly biases them against disclosure i.e. by greatly exaggerating the risks of disclosure and frightening them into believing that they will be criticized and harassed if their data is disclosed to critics. QMUL clearly have a conflict of interest here. About a dozen or so trial participants have already identified themselves on the internet over the years, and to my knowledge none were harassed and instead received appreciation or support. An independent mediator is a plausible solution only if trust can be guaranteed.

    Liked by 8 people

  7. The PACE trialists failed to disclose serious COIs to participants during recruitment. They changed their 2007 protocol to favour their therapies, while making it much harder to record serious adverse events. They are now using their alleged concern about patients in order to evade releasing anonymised data to academic researchers – but releasing the same data to other researchers for an IPD metaanalysis. Really, they have only themselves to blame for the antipathy and disbelief that greets them every time they open their mouths.

    Liked by 5 people

  8. Mr Schneider – thanks very much for this helpful summary of the data sharing issues. However there’s a couple of aspects of the situation that I still struggle to understand…

    1) If the PACE trial participants hadn’t given their data sharing consent (as Lewandowsky suggests) then why would King’s College give anonymised data to some independent researchers (and why would they admit this in the press release you quoted)?

    2) Why would the trial authors publish in PLOS One – an open access journal – when this would open them up to data sharing obligations that they knew they couldn’t honour?

    3) Why would they refuse data requests by Coyne (and others) as ‘vexatious’ when they had a more legitimate – and less confrontational – reason for refusal that they could use instead?

    4) The PACE trial was funded by the Medical Research Council. Their website states that their policy on data sharing is as follows:

    “The MRC expects valuable data arising from MRC-funded research to be made available to the scientific community with as few restrictions as possible so as to maximise the value of the data for research and for eventual patient and public benefit. Such data must be shared in a timely and responsible manner.”

    It goes on to say:

    “Our data-sharing policy applies to all MRC-funded research. It does not prescribe when or how researchers should preserve and share data but requires them to make clear provision for doing so when planning and executing research. The policy was approved by the Council in 2005.”

    The detailed policy guidance (http://www.mrc.ac.uk/publications/browse/mrc-policy-and-guidance-on-sharing-of-research-data-from-population-and-patient-studies/) sets out 21 mandatory principles which MRC funded studies have to follow.

    So, if the PACE trial authors followed the MRC guidance (as they should have done) how on earth have they ended up in a situation where they (apparently) can’t share data due to issues over patient consent and confidentiality?

    5) How will Wessely’s suggestion of an ‘independent’ oversight system solve the problem, if the problem is that patient consent hasn’t been given?

    Liked by 4 people

  9. I’m not sure I understand the idea of a ‘honest’ broker what would there role be and why would they be trusted and why they would invest time in doing it. If they were to criticize the PACE trial would they feel that their career would suffer because the weight of the establishment would come down on them. Or If they basically repeat the PACE analysis as is it won’t answer patients legitimate concerns – and they will know patients will examine the details to fully understand the answers. To get to the heart of the issues with PACE would take someone a considerable amount of time and effort for little reward.

    At the same time it is easy to anonymize the data and the data requested is not PII in any sense of the word.

    If there were to be an alternative solution I would suggest that the data scemas are published and the data are made available on a server and allow anyone to submit analytics. Results could be reviewed to check that they do not allow for identification of individuals. But this review would need to be independent of QMUL who appear confused about the notion of PII..

    This way the variety of different concerns of the patient community could be dealt with.

    It would also make a fascinating study for those like me who work in the area of data security and privacy and who are interested in safe sharing of data. There are of course technical issues as to why someone would trust that the results are computed correctly – this could be achieved through measuring the software stack using a published VM and trusted computing to check it boots correctly. Or is it sufficient to have test queries that match published results. This of course is one of the interesting questions and depends on the distrust between the various parties.

    Liked by 3 people

  10. Thank you for your excellent summary on this crucial topic. You write, “The PACE trial case might become a key test for the Open Data movement in academia”, and I believe you’re correct. The Open Data movement should be paying very close attention to PACE.

    The PACE authors claim that they are acting to protect patients, in accordance with a promise that they claim they made to them as part of the consent procedure. The Information Commissioner has ruled that the requested data are not personal and thus the authors would not be breaking this promise.

    But there are implicit as well as explicit promises that researchers make to patients in clinical trials and the PACE authors have broken those promises. Patients do not risk their health in clinical trials only for the study authors to publish bizarre and misleading analyses and then hide the data so that others can’t challenge them. By doing this, the PACE investigators have committed a terrible breach of trust between researchers and patients.

    You mention that patients and scientists “suspected a misinterpretation of data” but this isn’t a suspicion: it’s clear from the published material, and is summarised in the link below, for example. The PACE authors have produced no defence of their faulty analysis. I recommend that any scientist with an interest in PACE read the information in the link, to understand what is at the heart of patients’ need to get the data released for reanalysis.

    http://www.meaction.net/whats-wrong-in-the-lancet/

    Finally, you said, “It is probable that a functional solution to sharing of PACE data might be found, likely with the help of some kind of “intermediary honest broker“ proposed by Bishop” but I’m afraid that Dorothy Bishop is unlikely to have the trust of either patients or scientists familiar with PACE, given her connections to those who support PACE (described by Professor James Coyne):

    https://jcoynester.wordpress.com/2016/01/31/further-insights-into-the-war-against-data-sharing-the-science-media-centres-letter-writing-campaign-to-uk-parliament/

    It’s too late for “honest brokers” to be a solution to this issue, when it’s clear that the PACE authors have such extensive connections in academia. At this point, patient have completely lost trust in science when it is conducted behind closed doors.

    Time to set the data free.

    Liked by 8 people

  11. “many took it as general criticism of open science and data sharing. Except that it wasn’t.”
    Hmmm, really? Most of the responses to the Nature piece were critical, from many different people. Are you really suggesting that all these people, plus the Nature editors, misinterpreted what the piece was saying?

    It spoke of “Endless information requests”, “online harassment”, “attacks”. Data requesters were criticised by the suggestion that they found the results of the research “inconvenient”. Then later on, there’s more about “organized attacks”, “harassment”, “critics who are abusive or illogical”. And interspersed with all this, comments about the PACE trial controversy.

    Liked by 4 people

  12. (Apologies if this post appears more than once – I first posted it a couple of hours ago, but the internet seems to have eaten it…)

    Mr Schneider – thanks very much for this helpful summary of the data sharing issues. However if patient consent is really at the heart of this issue there’s a couple of aspects of the PACE trial authors’ behaviour that I struggle to understand…

    1) If the PACE trial participants haven’t given their data sharing consent (as Lewandowsky suggests) then why would King’s College give anonymised data to some independent researchers (and why would they openly admit this in the press release you quoted)?

    2) Why would the trial authors publish in PLOS One – an open access journal – when this would open them up to data sharing obligations that they knew they couldn’t honour?

    3) Why would they refuse data requests by Coyne (and others) as ‘vexatious’ when they had a more legitimate – and less confrontational – reason for refusal that they could use instead?

    4) The PACE trial was funded by the Medical Research Council. Their website states that their policy on data sharing is as follows:

    ‘The MRC expects valuable data arising from MRC-funded research to be made available to the scientific community with as few restrictions as possible so as to maximise the value of the data for research and for eventual patient and public benefit. Such data must be shared in a timely and responsible manner.’

    It goes on to add:

    ‘Our data-sharing policy applies to all MRC-funded research. It does not prescribe when or how researchers should preserve and share data but requires them to make clear provision for doing so when planning and executing research. The policy was approved by the Council in 2005.’

    The detailed policy guidance (http://www.mrc.ac.uk/publications/browse/mrc-policy-and-guidance-on-sharing-of-research-data-from-population-and-patient-studies/) then sets out 21 mandatory principles which MRC funded studies have to follow.

    So, if the PACE trial authors followed the MRC guidance (as they should have done) how on earth have they ended up in a situation where they (apparently) failed to obtain patient consent for data sharing?

    5) How will Wessely’s suggestion of an ‘independent’ oversight system solve the problem, if the problem is that patient consent hasn’t been given?

    Given the chronology of events it certainly appears that patient consent has only really become an issue in the last couple of months, as the calls for the release of the trial data have grown and the authors have found themselves needing a better excuse to refuse these requests.

    Liked by 6 people

  13. (Apologies if this appears twice – I think having two weblinks in my original post has consigned it to the spamtrap.)
    Thank you for your excellent summary on this crucial topic. You write, “The PACE trial case might become a key test for the Open Data movement in academia”, and I believe you’re correct. The Open Data movement should be paying very close attention to PACE.
    The PACE authors claim that they are acting to protect patients, in accordance with a promise that they claim they made to them as part of the consent procedure. The Information Commissioner has ruled that the requested data are not personal and thus the authors would not be breaking this promise.
    But there are implicit as well as explicit promises that researchers make to patients in clinical trials and the PACE authors have broken those promises. Patients do not risk their health in clinical trials only for the study authors to publish bizarre and misleading analyses and then hide the data so that others can’t challenge them. By doing this, the PACE investigators have committed a terrible breach of trust between researchers and patients.
    You mention that patients and scientists “suspected a misinterpretation of data” but this isn’t a suspicion: it’s a fact, and is clearly documented in the link below, for example. The PACE authors have produced no defence of it. I recommend that any scientist with an interest in PACE read the information in the link, to understand what is at the heart of patients’ need to get the data released for reanalysis.
    http://www.meaction.net/whats-wrong-in-the-lancet/
    Finally, you said, “It is probable that a functional solution to sharing of PACE data might be found, likely with the help of some kind of “intermediary honest broker“ proposed by Bishop” but I’m afraid that Dorothy Bishop is unlikely to have the trust of either patients or scientists familiar with PACE, given her connections to those who support PACE (described by Professor James Coyne in his blog post “Further insights into war against data sharing”).
    It’s too late for “honest brokers” to be a solution to this issue, when it’s clear that the PACE authors have such extensive connections in academia. At this point, patient have completely lost trust in science when it is conducted behind closed doors.
    Time to set the data free.

    Liked by 3 people

  14. Thank you for your balanced article on the issue of the PACE trial..

    Unusually in a medial trial, patients and the vast majority of the ME charities were against the PACE trial from its very inception in 2003 due to the fact that the “treatments” being researched and unsurprisingly being found to be helpful in the PACE trial were known to be at best valueless (CBT) and at worst very harmful (GET).

    However many unfortunately in the scientific community were hoodwinked into believing the PACE researchers hype into this trial.

    It was the recent work by investigatory journalist David Tuller which has now sparked the interests of scientists into closely analysing the PACE trial.

    If any of your readers who are interested they can find his work here on Virology:

    http://www.virology.ws/mecfs/.

    Liked by 2 people

  15. On the issue of PLoS ONE, notice how industry insiders at the Scholarly Kitchen spend valuable time peddling the impact factor as prediction gaming expands to science, as bets are hedged about the success and profitability of the Gold OA model:
    http://scholarlykitchen.sspnet.org/2016/02/02/as-plos-one-shrinks-2015-impact-factor-expected-to-rise/

    Science is being gamed, abused, predated, and this balanced perspective by Dr. Schneider may be fortifying that notion. Prediction gaming is dangerous for science: it induces bias, causes scientists to consciously or ingeniously abuse the system to their advantage, universities and research institutes will also latch onto pseudo-metrics that are predicted and gamed to increase rankings on global lists of “academic reputation”, and the vicious cycle of wealth extraction, all concepts so deeply ingrained in corrupted commercial practices, begins to enshroud science.

    The open data movement, much like the open access movement, I believe started as a genuinely positive notion, but gradually became corrupted by individuals and groups with non-academic interests.

    The PACE Trial represents that frontier between openness and accountability, and between stated rules and the application of rules across the board without exceptions. But it may represent a “complex exception” rather than the rule. I randomly selected 10 PLoS papers from a 2-3 year window and found that data to all papers were indeed open. So, for most other PLoS papers, the policy seems to be working, but something went wrong with the PACE Trial …

    Has anybody done a systematic revision of PLoS journals’ papers to see if all papers are open data compliant?

    Like

  16. Yes we need to see the data to calculate the true rate of adverse effects and to support the lawsuits to follow.

    However we don’t need any more data to show that the five million pound PACE trial is a bust, as the researchers have already admitted it. Don’t believe me? Well, here it is in their own words, from their own abstract on PubMed:

    “Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial.

    There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.”

    http://www.ncbi.nlm.nih.gov/pubmed/26521770

    Since GET and CBT have been shown not work, the policies built on these non-treatments must be changed immediately. Every day of delay is another day where uninformed and misinformed patients are being harmed by engaging in activity beyond their capacity.

    If cardiologists told their patients to shovel snow in frigid conditions, would the rest of society sit around and say, “Well, they are just useless eaters anyway. Who cares if they die early.”

    Liked by 4 people

  17. This and other articles have discussed the notion of data ownership and researchers not wanting to share data without co-authorship of papers.

    I do not understand the morals behind this especially in the case of medical trials. People agree to be experimented on in the form of clinical trials because they want to help research into their condition and benefit the world. In this case we are talking of government funded research where academics are paid to run an experiment, collect data and publish results. I believe most governments also stipulate the need to share data as part of there funding (including the MRC for PACE).

    So patients being experimented on expect their privacy but also expect the results of the experiments to be put to good use. Surely the moral case if to share data to increase knowledge of treatments.

    What is the moral case for academics refusing to share data unless they are co-authors?

    Although I suspect there are other reasons for the PACE team refusing to publishing data as defined in the published protocols, and only sharing data with those they feel comfortable with. Thinking about it the start of a process of gaining trust between patients and the PACE PIs need not involve onwardsmen or third parties but simply the release of the protocol defined data.

    I wonder about the ethical position of Queen Mary’s in helping keep data from patients. Are they really trying to protect researchers as if the published papers represent and accurate representation the release of data or at least the protocol defined outcomes would seem to be a natural way to move forward. But maybe they are just engaged in a brand management activity realizing that the data and particularly the recovery data and claims of cures has been spun. As a charity and public institution should they be spending money on lawyers to keep trial results out of patients hands.

    Liked by 2 people

  18. The issues of patient consent and ‘rich data sets’ seem to be a bit of red herrings in this case. While it is true that PACE trial participants were asked as part of the trial for potentially sensitive information including, but not limited to- a) their current wages/salary before tax, b) whether they currently receive income protection benefit or private medical/retirement pension and if so, how much, c) details of all jobs they have had in the past six months, d) age/sex/gender and which ethnic group that they identify as, and e) whether they currently are a member of a local self-help group for CFS/ME or national CFS/ME patient organisation, and if yes, to which organisation(s) do they belong, this is not the data that is being requested in the FOI request currently under appeal.

    What is specifically being requested is the following-
    • SF-36 physical function scores (range 0-100 points) [baseline and 52-week followup];
    • CFQ fatigue Likert scores (range 0-33 points) [baseline and 52-week followup];
    • CFQ fatigue bimodal scores (range 0-11 points) [baseline and 52-week followup];
    • Oxford criteria CFS caseness (does participant meet criteria, yes or no) [52-week followup only];
    • Participant-rated CGI scores (range 1-7) [52-week followup only];
    • Doctor-rated CGI scores (range 1-7) [52-week followup only];
    • 6MWT walking distances (in meters) [baseline and 52-week followup];
    • The group which each participant was allocated to after randomisation (i.e. either to APT, CBT, GET, or SMC).

    For the PACE investigators to claim that such basic information as anonymized SF-36 and Chalder Fatigue Scale scores constitute ‘sensitive personal data’ is ridiculous on its face, which is why the Information Commissioners Office rejected every single one of QMUL’s arguments resisting release of the requested information.

    I think what patients would ideally like to see would be the following-

    1. For the full trial data to be re-analyzed according to the original published trial protocol and/or statistical analysis plan as written by the PACE authors themselves. This itself could determine whether patients’ many concerns about the trial are justified, ie whether the numerous changes to the trial protocol over the course of the trial had the effect of making it substantially easier for the investigators to claim success while simultaneously making it harder for participants to report being made worse. This is perhaps most clearly displayed in the Lancet primary outcomes and ‘recovery’ publications, where the criteria for ‘recovery’ overlapped with the criteria for entry into the trial, a patently ridiculous situation. I, for one, fail to see how this could possibly qualify as ‘data dredging’ or ‘torturing the data’ as has been suggested by other commentators.

    2. Following the above, it seems like a logical next step would be to see if any reported improvements correlated with any of the objective measures of outcomes included in the trial, which included a self-paced step test, 6 minute walk test, employment status, receipt of disability benefits, etc. This is especially important since PACE was a non-blinded trial (at best) and used subjective outcome measures, a situation that would otherwise not even be accepted in a simple homeopathy trial, much less a £5 million research study.

    One other thing that could be put into place would be for journals to require publication of protocol-specified outcomes alongside any changes made during the course of the trial. That alone could have prevented a lot of the uproar over the PACE results to begin with.

    Liked by 8 people

  19. An important detail about Peter White’s campaign to exempt universities from the freedom of information act. This came to light after the Information Commissioner’s Office ordered Queen Mary University London to release PACE data.

    The university argued that the requested information was personal data, but the commissioner decided that the witheld information does not constitute personal data.

    This is documented here (and the university also argued that the request should be refused for three other reasons, which the commissioner also disagreed with).

    https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1560081/fs_50565190.pdf

    The university has appealed this decision rather than releasing the data.

    The dispute will be solved in the information tribunal during a three day hearing on April 20-22.

    https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/496756/information-rights-tribunal-register-cases.pdf

    Liked by 1 person

  20. Thanks for exploring these issues, Leonid. I’m very glad the PACE debate is achieving greater attention, given how long patients have suffered under the CBT/GET approach. Open access to data is obviously critical to scientific integrity. I would like to note that in the case of PACE, at least, the data are not necessary to see that the trial’s flaws are indefensible and the results essentially meaningless. Once released, the data will likely confirm that even their own results, per the protocol, were null. But the documented violations already make a good case for retraction, as I argued at great length on Virology Blog: http://www.virology.ws/2015/10/21/trial-by-error-i/

    Liked by 4 people

  21. My interpretation of the PACE trial’s consent form (see clause 3 in the form) [1] is that it does not allow for the investigators to share personal information. The consent form made no allowance for the sharing of personal data whatsoever, except for the specific purpose of auditing the trial by regulatory bodies.

    By their own acknowledgement [2] the PACE investigators have already shared anonymised individual data with other select research teams of their choice e.g. with the Cochrane group for a meta analysis of individual data.

    So, either the investigators are breaching the participants’ consent agreement by sharing data, or anonymised data is not personal data and the consent agreement has not been breached.

    The UK’s information commissioner’s office (a quasi-judicial agency) has ruled that anonymised unidentifiable data is not personal data [3], and that the requested PACE data has little risk of being re-identified and should be released [4].

    The various ongoing requests for data by patients and researchers have not asked for any personal information or identifiable data.

    The PACE investigators’ reasons for denying the PACE data has changed over time. Denial of data has been consistent but the reasons given have been inconsistent. Only recently have the investigators settled on patient confidentiality as a reason to deny data.

    The investigators have also raised the issue of reputational damage as a reason to withhold the data [5], so perhaps such fears are central to the reasons for withholding the PACE trial data.

    Dorothy Bishop proposes that an independent body is set up to analyse or oversee the data. But this defeats the idea of open data. It is only by full access to the data, that full scrutiny can take place. It is only by scrutinizing data that e.g. potential anomalies, errors and outliers can be spotted. Unexpected issues with methodology might only be spotted by scrutinizing the data. But, also, full access is needed for investigators to experiment with the data, to look for unexpected patterns, or to constructively build upon previous publications. It is widely recognised that publicly funded data should be available for the public good.

    Furthermore, if patients suspect that medical trial data is being misrepresented then there is a strong case for the patient community being able to scrutinize that data, because misrepresentation of data has the potential to harm patients. Patients’ rights and safety must take a high priority whatever the discomfort to researchers. But even if there is no suspicion of wrongdoing, patients should surely have access to the information upon which their treatment choices are decided, especially when that data is 100% publicly funded and is held by a public body supposedly with a view to improving the lives of patients. Patents need access to data to make informed decisions about their health care.

    Simon Wessely (a contributor to the PACE trial) says that the trial data may be released to an ‘independent’ body attached to the investigators’ university. But that raises more questions than it answers. Access to the data would be limited and held by a body that would not be seen by the public as independent.

    Data sharing may be uncomfortable for researchers. But science doesn’t advance by patting colleagues on the back and telling our colleagues what a wonderful job they’ve done. Science advances via a healthy and robust process of creativity, rigour, scrutiny and testing hypotheses to destruction.

    The PACE trial data is 100% publicly funded and is a public resource.

    References.
    1. https://www.whatdotheyknow.com/request/203455/response/508208/attach/html/3/Consent%20forms.pdf.html
    2. http://www.kcl.ac.uk/ioppn/news/records/2015/december/release-of-data-from-the-PACE-trial.aspx
    3. https://ico.org.uk/for-organisations/guide-to-data-protection/anonymisation/
    4. https://ico.org.uk/media/action-weve-taken/decision-notices/2015/1560081/fs_50565190.pdf
    5. https://dl.dropboxusercontent.com/u/23608059/PACE%20F325-15%20-%20Prof.%20James%20Coyne%20-%20Response-2.pdf

    Liked by 4 people

  22. “In this regard, Simon Wessely, professor of Psychological Medicine at the King’s College London, indicated over Twitter that “a robust trusted independent system” is being set up at his university “because at the moment there is no trust”. This supposedly with the purpose of assuring proper confidentiality of the trial participants’ data.”

    To be truly independent and objective, the reviewers must NOT be affiliated with the PACE team, or the UK psychiatric belief that all unexplained illnesses are psychosomatic. Ideally, they should be experienced research statisticians, from another country, with no affiliation or attachment to the PACE theory.

    Liked by 1 person

  23. Thank you for your description of this needlessly complex subject. There is nothing complicated about the PACE trials – or at least, there should not have been. Patients were selected to participate in a trial of cognitive behaviour therapy targeted to their “inappropriate illness beliefs” and a course of “graded exercise therapy” to get them back in shape – together this is called CBT/GET and has been proclaimed as the “best” treatment for ME and CFS by the governments of the UK, the US, among others, for two decades now.

    These treatments are controversial, to say the least. The main reason is that the entire programme of “CBT/GET” with regards to ME and CFS is based on the assertion that the patients’ physical symptoms have no medical explanation – in insurance (and now medical) parlance, these patients all have “MUS”s (Medically Unexplained Symptoms);.

    But there are numerous studies that DO offer a medical, or physiological, explanation for the symptoms. Most specifically, research has shown that high-functioning patients who fit the Canadian diagnosis of ME/CFS (2003) do perform roughly the same as deconditioned controls on CPET (cardio-pulmonary exercise testing) – but on the SECOND day, while the deconditioned controls perform the same as they did the day before, the patients’ scores drop by as much as one-half.

    The CPET has long been used in cardiology – and athletics – and is highly regarded as objective. It can’t be gamed. The tester puts a mask over the patients nose and mouth (or over the mouth and clamps the nose shut) so that the air going into and out of the patients’ lungs is measured by a machine while the patient rides a stationary bicycle or walks on a treadmill that gets progressively more difficult. When the patient reaches maximal cardiac effort [a pulse of (200-age) x .8], the machine records the amount of oxygen intake and carbon dioxide release – that is, it measures how much oxygen the patient inputs and how much carbon dioxide has been produced.

    CPET testing of patients with ME or CFS – which has now been replicated on three continents by numerous researchers (and is into second-order studies where the patients’ blood is tested for other characteristics before, during, and after testing) has effectively demonstrated that what patients have been saying for years – and what has been recognized by the non-psychiatric school of thought regarding the disease – is both profound and measurable – patients suffer from what is called in the literature “post-exertional malaise” or post-exertional worsening of symptoms.

    This symptom is considered so profound, and so important, that a recent report of the Open Medicine Foundation at the US HHS concluded it should be a REQUIREMENT for the definition of the disease.

    Now, imagine a patient for whom a defining symptom is the inability to maintain the SAME level of exercise two days in a row. Imagine a treatment where the patient is told to (1) increase exercise daily, and (2) ignore how it makes them feel. These patients end up operating in constant anaerobic metabolism, which is dangerous for trained athletes – certainly it is dangerous for patients.

    Here we come to my own frustration with this literature. The psychiatric literature on the disease known as ME and/or CFS does not reference the great body of literature on physical abnormalities found in the disease. Those who know nothing of these diseases who read this psychiatric literature won’t know about post-exertional “malaise” (or worsening of symptoms); won’t know about significant cognitive dysfunction and sleep abnormalities; and – above all – won’t know that one-fourth of patients are either bedridden or housebound.

    Here, then, is the major source of the division between QMUL/KCL and the rest of the ME/CFS community. The QMUL/KCL world admits to NO evidence of physical abnormalities in patients with this disease – an assertion I do not believe they are entitled to make. Certainly readers should have the opportunity to choose for themselves; a full and objective bibliography should be provided by the authors, not just a bibliography of work that agrees with their thesis.

    Under the circumstances, the authors of this £6 million study – which used taxpayers’ funds – are being suspiciously coy. Patients have insisted for years that the CBT/GET protocol is not just meaningless – it is DIRECTLY HARMFUL. Indeed, if CBT/GET were a pharmaceutical drug instead of a protocol, it would have been denied a long time ago on the basis of the number of adverse events.

    But both the UK and the US governments continue to recommend this treatment – and they base that recommendation on the PACE trials plus the body of literature written by the schools of psychiatry at QMUL and KCL.

    It is not just an academic discussion. POLICY choices rest on the conclusion. TREATMENT choices rest on the conclusions.

    IT IS IMPERATIVE THAT WE GET THIS RIGHT. If the authors are wrong, then this is actually harming patients, even as I write this sentence. They would probably consider that sentence harassment. But how else am I to say it? There is evidence that the adverse events from this treatment protocol are being swept under the rug.

    One million American adults suffer from this disease. 250,000 patients in the UK are also victims. This is too important not to make absolutely certain we are doing the right thing.

    What I do not understand is why the psychiatrists at QMUL and KCL don’t agree with that.

    Liked by 2 people

  24. Simon Wessely, professor of Psychological Medicine at the King’s College London, has forwarded me this important message on data sharing and patient privacy in UK:

    “I sense that people are starting to wake up to the fact that open data/ data sharing is not as straight forward as it first seemed. In this country and elsewhere there is a complex legal framework around data sharing, and one that is also constantly changing in the light of two particular issues. The first is the fiasco of “care.data” [https://www.england.nhs.uk/ourwork/tsd/care-data/ -LS] in this country, and no doubt similar issues elsewhere, which means there has been a loss of confidence in our existing systems of data sharing and linkage, and increasingly people are wanting to have more say in what their personal data is used for. The second, not unrelated, is the increasing power of computer technology both to generate mammoth data sets, but also to permit re-identification of individuals which would hitherto not have been possible. Both of these developments mean that the old divisions between identifiable data (for which consent for sharing must be sought, unless there is specific case by case legal justification not to do so, a complex bureaucratic procedure) and anonymised or pseudo anonymised data, is being tested. There are even calls that consent is needed for sharing truly anonymised data, although that does seem to many, including myself, rather ridiculous. But such voices are definitely being listened to, following the ever increasing importance attached to autonomy, confidentiality, consent and choice by Courts and regulators alike.

    What is clear is that the general atmosphere around data sharing, especially of sensitive data such as medical information, is in a state of flux. Indeed several reviews are ongoing in this country which are likely to make data linkage and sharing more onerous, and eventually there will be new legal rulings, which again are unlikely to produce a more liberal approach to data sharing/linkage.

    Sooner or later I anticipate there will be a collision between the open data movement and the legal framework around data protection, at least in the UK. As an epidemiologically trained researcher I am anxious about the consequences of this, since I doubt very much it will make data sharing and linkage easier, rather the reverse. I hope I am wrong, but the fall out from care.data has been so toxic that I suspect the direction of travel will be in one direction only. At least in England”.

    Like

    1. Interesting point about “the fiasco of care.data” but the fiasco of the PACE trial might be instrumental in pushing the debate the other way. There are clear harms to patients through lack of openness.

      Liked by 1 person

    2. Leonid,

      The problem with Simon Wessely’s comment about the changing data sharing landscape – at least with regard to the PACE trial – is that the MRC (who funded the trial) has been actively promoting data sharing since 2001. Their Council approved a draft data sharing policy in December 2002 and it was posted on their website in early 2003 – i.e. before the PACE funding application was approved. The final version of the policy was signed off in early 2005 – i.e. around the time that PACE signed up the first trial participants. It was abundantly clear before the trial began that the MRC expected the authors to make their data available – and yet despite this there doesn’t seem to have been any mention of data sharing in the consent forms, the trial protocol or on the trial website. The PACE team simply seem to have completely disregarded the MRC policy.

      This is what the MRC website said about data sharing in March 2004 (the earliest reference I can find with archive.org)

      “Data Sharing and Preservation are “the norm”

      At its December 2002 meeting, Council agreed a draft statement of policy on the sharing and preservation of research datasets. It reaffirms the principle that data sharing in research is “the norm,” while recognising the special responsibilities that researchers have in relation to people, their data and their legal and ethical rights.

      Good practice, needs and concerns of the MRC-funded population-based research community were highlighted in a report to the MRC in 2002 from the UK Data Archive (UKDA) on a study of sharing and archiving practices in MRC-funded population research (including clinical trials). The UKDA study built on the work of MRC’s Data Archiving Working Group, chaired by Professor Sally Macintyre. MRC welcomes comments on UKDA report, particularly in identifying what in the report is helpful and what further guidance the community would value.

      Meanwhile, Council has decided that the MRC will actively promote collaborative data sharing and preservation in population research by encouraging a life-cycle approach to data management, and by facilitating identification and development of generic informatics standards, tools and guidance. The strategic goals of the initiative should be seen as part of Council’s broader commitment to developing the informatics base for multi- and inter-disciplinary science.

      For their part, custodians of significant data resources will be expected explicitly to outline their plans for sharing and preservation in their research proposals, or to explain why the datasets are not amenable to sharing.”

      By November 2005 the website had been updated to read:

      “MRC promotes the view that publicly-funded research data are a public good and that as such, investigators have a duty to make their data available to share in a responsible manner.

      MRC’s data sharing and preservation policy sets out general principles which apply to all MRC-supported research. It does not prescribe when or how investigators should preserve and share data. Some data can be shared pre-publication; the value of other data can be realised only after a longer data-gathering period.

      The policy prompts investigators, after first considering what is appropriate and reasonable, to make explicit provision for the preservation and sharing of data in the planning and execution of their research.”

      Note the first line of that second paragraph – “MRC’s data sharing and preservation policy sets out general principles which apply to all MRC-supported research”. That would include the then recently commenced PACE trial. So what did the finalised policy actually say? Well it started like this…

      “MRC expects that the valuable data arising from the research it supports will be made available to the scientific community to enable new research with as few restrictions as possible. Such data must be shared in a timely and responsible manner.”

      The PACE authors have clearly ignored this expectation. The policy went on to make the following comments on patient consent:

      “Medical research involving personal data has special responsibilities associated with it, particularly in relation to consent and confidentiality. It is essential that the appropriate regulatory permissions – ethical, legal and institutional – are in place prior to sharing data of this type. Researchers, research participants and research regulators must ensure that, within the regulatory requirements of the law, opportunities for new uses are maximized without unnecessary restriction. Potential research benefits to patients and public should outweigh identified risks. Risks such as inappropriate disclosure of personal information must be managed in a proportionate yet robust manner.”

      To me this reads as a clear instruction to people undertaking MRC-funded research of the need to obtain appropriate patient consents to enable data sharing to take place. And yet, as I’ve already said, the PACE authors didn’t make any mention of data sharing in the consent forms.

      From what I can gather the final 2005 version of the policy was very similar to the draft 2002 version (although I haven’t been able to find the 2002 text, so I can’t be 100% sure of this), so the final policy shouldn’t have come as a surprise to the PACE authors given that it had been in development at the MRC for the preceding 3 years. But even if they were completely unaware of the policy until it was finalised, it wouldn’t have been difficult for them to update their consent forms to include specific data sharing consent. By September/October 2005 they’d only signed up the first 100 of their 600+ patients, so by updating the forms they could have obtained explicit data sharing consent from the majority of the trial participants.

      Instead it seems that they decided to ignore this requirement as well – and it appears that they are now using this omission as a justification for why data sharing can’t take place.

      Liked by 3 people

    3. “this important message”

      Important for showing how difficult it is for Wessely to position himself on this issue. Evasive and irrelevant to the matter of the PACE data the ICO ruled QMUL should release though. Also similar to his Mental Elf blog in the way that it really side-steps and ignores the specific points critics of the PACE trial researchers have been making.

      Like

  25. I think that it interesting that Wessely makes no arguments that relate to the PACE data.

    There are huge issues with sharing general medical data. The problem will get much worse as we can collect much more but Wessely doesn’t manage to relate any of that to the requested PACE data

    Take something such as the sf36 scale. It essentially has 21 points so we have 641 patients mapping down to 21 points (and given the constraints of the trial in reality much fewer points). So there is a huge information reduction step that goes on here. It is simply not possible to map back from the sf36 score of 60 to adrian – the information does not exist for the mapping. Let alone to choose 1 patient from a possible set of 250,000 within the UK.

    Like

  26. The claim made by Prof Wessely (Feb 19) that computers might somehow allow re-identification of individuals, was rebutted before it was made by Bob in his well argued and carefully referenced comment (Feb 8).

    From paragraphs 57 and 58 of the ICO report linked by Bob,
    “Whilst the Commissioner acknowledges the possibility that some individuals may be able to identify themselves in the withheld information, he does not believe that this is sufficient for those individuals to be identifiable for the purposes of section 40(2).”
    “[The University] has not provided any evidence as to how the motivated intruder might be able to actually identify participants from the trial from the information contained in the requested information and other information that may be available to such an individual. There is no indication in the University’s submissions to the Commissioner as to what means are reasonably likely to be available to the motivated intruder to facilitate re-identification.”

    My expectation, based on a previous incident a few years ago where a university refused to release data with poor excuses, is that the appeal noted by A.B. will be rejected and the data will have to be released.

    Liked by 3 people

  27. Quite what legal landscape Professor Wessely envisages is very difficult to divine, but his contention that “there will be a collision between the open data movement and the legal framework around data protection, at least in the UK” seems wholly without basis. Under the care.data project, in 2012 the UK Department of Health and NHS England both egregiously failed to abide by the provisions of those Data protection Laws which are separately administered under the jurisdictions of England and Wales, Scotland and Northern Ireland. For analysis of the administrative failure see: http://techscience.org/a/2015081103/ . There was no failure of the Law, simply a gross breach based on the arrogance of the Westminster Government. There was equally no implication that the breach involved any relevance to the sharing of data from properly regulated research. All the problems of Law relate to the 2012 Health and Social Care Act http://www.legislation.gov.uk/ukpga/2012/7/contents/enacted which has no significant relevance to the regulation of research.

    Medical researchers working for the NHS in England no doubt experience many difficulties in negotiating the ideological contradictions of the Westminster Government, a Government which at times appears to be at war with NHS staff http://www.independent.co.uk/news/uk/politics/junior-doctors-furious-after-new-example-rotas-show-them-working-three-weekends-in-a-row-a6882541.html . But none of this has anything to do with the sharing of anonymised data from well regulated research, and either Professor Wessely is confused or he is seeking to obfuscate the otherwise very clear case of the PACE data.

    Like

  28. The bottom line is PACE data needs to be made avaialable as this mockery of a study and its recommedations have been used by health authoritities around the world. The result of such flawed medical research is funding shortages, stigmas, loss of families, employment, QOF, permanent bodily harm and death for the millions affected with ME/CFS.

    THAT IS WHAT PACE HAS DONE TO THE ME/CFS COMMUNITY AND NOTHING MORE!

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  29. The PACE Trial Gets Its Most Devastating Critique Yet: a full blown critique by Dr Rebecca Goldin, Professor of Mathematical Sciences and the head of a statistical organization.

    She writes, “The study is under increasing scrutiny by scientists and science writers about whether its conclusions are valid. The question of how all this happened and how the criticism is being handled have sent shockwaves through medicine”.

    She added, “The results from PACE… have been published in prestigious journals and influenced public health recommendations around the world; and yet, unraveling this design and the characterization of the outcomes of the trial has left many people, including me, unsure this study has any scientific merit. How did the study go unchallenged for five years?”

    http://www.stats.org/pace-research-sparked-patient-rebellion-challenged-medicine/

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