How should clinical trial data be shared?
BMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f4465 (Published 12 July 2013) Cite this as: BMJ 2013;347:f4465All rapid responses
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We would like to clarify that the proposal encompassed by the RIAT declaration is on restoring the published written record documenting the findings from a clinical trial, not the type of data used to restore the record. The RIAT proposal focuses on the use of original, highly detailed, clinical study reports (CSRs) that are already in the public domain (most often because a legal case or a regulator has released the material under Freedom of Information requests). RIAT does not require that a specific form of data (i.e., summary data or individual participant data) be used. Sometimes, but not always [1], CSRs include case report forms and individual listings.
[1] Doshi P, Jefferson T. Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports. BMJ Open. 2013 Feb 26;3(2):e002496. http://dx.doi.org/10.1136/bmjopen-2012-002496
Competing interests: PD and TJ have published on influenza antivirals and received a UK National Institute of Health research grant for the update and amalgamation of two Cochrane reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. PD received support from the European Respiratory Society for travel to the society’s September 2012 annual congress where he gave an invited talk. He is funded by an institutional training grant from the US Agency for Healthcare Research and Quality. AHRQ had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. KD served as an expert witness in 2008 litigation against Pfizer relating to gabapentin. Funds from this effort were donated by the plaintiff’s lawyers to Johns Hopkins to support academic scholarship in the area of reporting biases. DH has been an expert witness in legal cases that have brought to light issues surrounding non-publication of trials and ghostwriting and an action by New York State that led some of the documents this article references to come to light. SSV was paid by the plaintiffs’ lawyers for assisting KD with preparing her expert witness report in 2008 litigation against Pfizer. SSV’s research related to reporting of trials in off-label uses of gabapentin was supported by an academic scholarship established at Johns Hopkins using funds from KD’s effort as an expert witness in the 2008 litigation against Pfizer. TJ receives royalties from his books published by Blackwell and Il Pensiero Scientifico Editore. He is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 products. He was a consultant in a legal case regarding oseltamivir.
Re: How should clinical trial data be shared?
Miriam Tucker’s article inadvertently brings out some key features about RIAT. She reports Dr Califf as suggesting it takes expertise to write up clinical trials, and as being in favor of GSK's proposals on data access. I have no idea whether he has been accurately reported or not - I do not have access to the tape she made of her interview and she did not use a RIATAR to track how she got from the original data to her final report. There is an act of authorship here that intervenes between the data and final article.
Clinical Trial Reports are also authored - they do not arise magically from the data. As things stand with the overwhelming majority of company clinical trials being ghost-authored (Avandia trials for instance), we have no way of knowing just how much expertise is in fact deployed. Those doing the analysis probably in most cases have little hands on trial experience and no contact with the trial patients.
"Expertise" in these debates is often code for someone using the same analytic techniques the original company used and coming to much the same conclusions. These techniques are a further aspect of authorship. Expertise of this sort is at the heart of GSK’s recent "data access" proposal, which are more about authorship than data access.
There is no technique for adjudicating between statistically significant drops in glucose levels and non-significant increases in mortality, for instance. It is an act of authorship to emphasize one over the other.
When it comes to issues like these, the RIAT process helps reveal the act of authorship involved. This realization will hopefully lead to greater scrutiny of claimed “expertise”.
In contrast to GSK, the currently under threat EMA position on data access has not required a demonstration of "expertise", and this is perhaps why it is under threat.
Competing interests: One of the authors of the RIAT paper