Half year passes without release of PLOS One PACE trial data

A half a year has passed since I made the request for the PACE trial data used in a PLOS One article.


  • Greater transparency is a must in the ongoing negotiations about release of the data between PLOS One and PACE investigators and their lawyers.
  • The needs of stakeholders other than the PACE investigators must be recognized and the stakeholders need to be engaged in a more transparent process.
  • Retraction of the PACE PLOS One article is an attractive option that would highlight that the PACE investigators are hiding something in their data.

It has been over 180 days since I formally requested on November 13, 2015 the data from PACE cognitive therapy for chronic fatigue syndrome trial used for an article in PLOS One. The latest communication suggests that the management of PLOS  is still negotiating with lawyers from Queen Mary University, London. Agreement seems to be reached that any release of data will require a preregistered plan of analysis.

The PACE investigators notoriously did not stick to the analyses originally proposed in their protocol. Not doing so and a lack of transparency as to what analyses specified original proposal would yield raises serious questions about what they are hiding.


Please pass the data.

Having published an article in PLOS One, the PACE investigators should be held to their promise of sharing their data or have their paper retracted. I would be comfortable with the latter decision because it would affirm that the investigators have something to hide.

I’m concerned what half a year of nontransparent negotiations with no results mean for the data sharing policies of PLOS One.

Meanwhile, another PLOS One article  has appeared that not only has undeclared conflicts of interest, but an apparent conflict of interest in the PLOS Academic Editor has appeared. An investigation by the journal confirms that the authors do indeed have a conflict of interest that must be declared in an erratum. But time is passing with no such erratum being posted. No decision has been reached about my complaint about the apparent conflict of interest an academic editor from the same department as the authors making the decision to the article to publish it. The article is essentially a poorly designed, crass experimercial with limited contribution to the literature, but instead designed to promote services of a complementary medicine center.

But important to the struggle over release of the PACE trial data, the authors of this second dubious article refused to share the data for reanalysis. Continued delay in resolving the earlier request for the PACE trial data can only mean delay in resolving the clear-cut issue with this other article. Moreover, a decision regarding the PACE data reflecting anything but a reaffirmation of the PLOS One requirement for data sharing would be a barrier to resolving this other failure to share data and a signal to other authors that they do not have to share their data if they publish in PLOS regardless of what they have read.

I think it’s high time for PLOS One to announce a deadline for release of the PACE trial data, which if it is not met will result in a retraction.

But more immediately, the management of PLOS One should adopt a policy of greater transparency in the negotiations with the PACE investigators and their lawyers. There are numerous other stakeholders :

– Readers for whom the credibility of PLOS articles is based on the availability of data allowing independent confirmation of the interpretation and conclusions expressed by particular authors.

– Authors who select PLOS One because of its commitment to data sharing.

– Patients and policymakers who depend on the trustworthiness of the results reported in the PLOS One article.

– Thousands of PLOS One academic editors and reviewers who donate their time for free because of the commitment of the journal to data sharing.

where-does-the-time-goIt would be a pity if PLOS One made any concession to the lawyers of Queen Mary University and the PACE investigators by restricting access to the data used in the PLOS One article.

It would be a blow to the fine reputation of PLOS One and a blow to an already faltering movement for routine sharing of data for all peer-reviewed scientific publications


6 thoughts on “Half year passes without release of PLOS One PACE trial data

  1. I would copy the “preregistered plan of analysis” that the original trial registration used. If there was a need to modify what ever that “preregistered plan of analysis” was after seeing the actual data from the trial, certainly the trial researchers can’t object if this re-analysis requires modification to the “preregistered plan of analysis”.


    • Precisely. Any and/or all of the protocol-specified analyses would make for an excellent plan of analysis. In addition you could also include objective measures of outcome to the primary analysis, for instance to see if ‘improved’ or ‘recovered’ participants had any objective improvements in any of the objective measures in the trial- 6 minute walk test, self-paced step test, receipt of benefits, etc. Basically see if anything improved other than questionnaire scores.


  2. This is the problem of having a policy without an enforcement mechanism.

    You have probably stated this elsewhere but PLOS and other journals should really require that researches hand over a copy of the anonymised data so that it can be published and made available to everyone in some online repository at the moment of publication.


  3. I think it is worth adding country based analysis of the EQ5d scores to their prespecified analysis. Each country has different sets of weights for combining the different dimensions of the EQ5D and this can lead to different results in different countries. I believe some treatments that were found to be cost effective in some countries were not in others.


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