Do not think it worth while to proceed by concealing evidence, for the evidence is sure to come to light. -Bertrand Russell
The PACE investigators have issued guidelines for requesting access to their trial data.
Based on my past experience with them, I would suggest don’t bother to go this route.
These guidelines best be viewed as a ruse to trap the unwary in endless haggling and appeal, while protecting the PACE investigators from the independent reanalysis of the claims, which they have already declared poses a reputational risk to them.
Rather, I suggest that interested parties wait for PLOS One to secure the access to the data that was promised as a condition for publishing a paper there. The wait for PLOS One to enforce their data-sharing plan could also be a long time, but it would be preferable to a long and ultimately frustrating process of trying to obtain the data from the investigators through these new guidelines.
For those of you who have not heard of the struggle for release of the data from the publicly funded PACE trial of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome, you can access my initial call for release of the portion of the data from the trial published in PLOS One:
Here is support from Stats News for release of the PACE trial data:
Coyne’s not asking for sex tapes or pictures of lab workers taking bong hits. He’s asking for raw data so that he can evaluate whether what a group of scientists reported in print is in fact what those data show. It’s called replication, and as Richard Smith, former editor of The BMJ (and a member of our board of directors), put it last week, the refusal goes “against basic scientific principles.” But, unfortunately, stubborn researchers and institutions have used legal roadblocks before to prevent scrutiny of science.
And my half-year update on my request:
Despite the investigators’ having promised the data would be available as a condition of publishing in PLOS One, 18 months after making my request, I still have not received the data and the PACE investigators are continuing to falsely advertise to readers of their PLOS One article that they have complied with the data-sharing policy.
The article’s conflict of interest statement reads:
Competing interests: PDW has done voluntary and paid consultancy work for the United Kingdom Departments of Health and Work and Pensions and Swiss Re (a reinsurance company), and led a randomised controlled trial about graded exercise therapy funded by the Linbury Trust. TC has received royalties from Sheldon Press and Constable and Robinson. MS has done voluntary and paid consultancy work for the United Kingdom government, has done consultancy work for the insurance company Aegon and has received royalties from Oxford University Press. PM, ALJ, KAG, and MK declare that they have no conflicts of interests. This does not alter the authors’ adherence to all the PLoS ONE policies on sharing data and materials.
The investigators’ new guidelines are accessible here and some key provisions are discussed below.
Guidance for researchers requesting access to data from the PACE trial
We support the use of PACE trial data for additional, ethically approved research, with justified scientific objectives, and a pre-specified analysis plan. We prefer to collaborate directly with other researchers. On occasion, we may provide data without direct collaboration, if mutually agreed.
These are the provisions under which the pharmaceutical industry has long provided funds for evaluating their products, while retaining control over what is said about them. “We prefer to collaborate directly… On occasion we may provide data without direct collaboration.” I wonder if they will provide ghost writing as well, as in
Certainly the dirty deeds of Pharma referred to in the title of that blog post and well documented with legal documents in the text have also been committed by the PACE investigators.
Applicants should state the purpose of their request, their objectives; qualifications and suitability to do the study, data required, precise analytic plans, and plans for outputs. See published protocol for details of data collected.
Note that an application must include precise analytic plans. But the context for interest in release of this data is the controversy over the results claimed by the PACE investigators, as well as their switching of outcomes, coordinated with the switching in some other trials over which they had influence. It would be appropriate to re-analyze the PACE trial data according to the original protocol and to conduct sensitivity analyses that might reveal the basis for their having switched the outcomes. This kind of forensic probing with sensitivity analyses precludes an independent investigator specifying precise analytic plans ahead of time. Of course, whatever results the investigator obtained would have to be labeled exploratory and post-hoc, but this is exactly the kind of situation in which trial data should be subject to exploratory, post-hoc reanalyses.
This is one of a number of loopholes in these guidelines that allows the PACE investigators to reject an application for data sharing after a drawn out process that could involve lengthy appeals.
A formal agreement should be drawn up between Institutions i.e. the owner of the data and the Institutions employing those requesting data. Agreement is needed regarding safe data transfer, secure storage, and legitimate use of the data.
Good luck in getting a formal agreement approved. Who is to say that the investigators won’t ultimately reject an application because reproducing the analyses with the original, protocol-specify outcomes is not a legitimate use of the data.
Data will be provided with personal identifiers removed. Applicants must agree not to use the data to identify individual patients, unless this is a pre-specified purpose for record linkage.
Individual researchers who will see the data must sign an agreement to protect the confidentiality of the data and keep it secure.
That is appropriate, but an ironic shutting of the barn after the cows got loose. The PACE investigators carelessly stored videotapes from the trial marked with patients names in an unlocked file drawer. Some of these tapes was subsequently stolen.
And the PACE investigators obtain the data from patients with consent forms did not disclose their financial conflicts of interest, a violation of the Declaration of Helsinki.
In the event that the request is declined, reasons will be communicated to the requestor.
An independent appeal process is available.
That’s great, and you can get very old waiting for the appeal process to finish.
Whilst final decision to publish using the data remains with the researchers who have used the data, it is requested that a draft report or paper including the results and interpretation be shared with PACE co-principal investigators for feedback.
“For feedback”? I really don’t think a publication based for re-analyses would be approved, but then again I don’t expect the whole process to get this far anyway.
This guidance is consistent with data sharing guidance policies of Queen Mary University of London, and the Medical Research Council, which funded the PACE trial.
This is an untrue statement. The Medical Research Council has explicitly endorsed liberal data sharing that protects the rights of patients. In contrast, the guidance issued by the PACE investigators has loopholes allowing them to control what analyses are done and whether they get published. The Medical Research Council states
Every year, the MRC invests around £850 million of public money in research, the primary output of which is data. We want to maximise the research opportunities that such a diversity, richness and quantity of data provides. One of the best ways of achieving this is to ensure that data are properly preserved for sharing and informed use beyond the originating research teams.
Anyone requesting data from the PACE investigators can expect a rude and unprofessional response. I didn’t make my request for the PLOS One data using a Freedom of Information Act request. I simply wrote a letter to one of the investigators and asked for the data to be provided has they had promised in publishing in PLOS One. My request was turned into a freedom of information act request and it was rejected. The investigators deemed my requesting it as vexatious and they claimed I was only motivated to damage their reputation with my re-analyses. Well, they are a team of talented psychologists and psychiatrists.