Don’t do the crime if you can’t do the time…
Medscape Medical Newsby Janis C. KellyJul 31, 2013The movement to increase the transparency of clinical trial data accelerated this week when GlaxoSmithKline [GSK] officials announced the company would provide access to deidentified patient-level data from GSK-sponsored clinical trials to research teams seeking to use those data to address specific scientific questions. In a special report published in the August 1 issue of the New England Journal of Medicine, Perry Nisen, MD, PhD, senior vice president for science and innovation, and Frank Rockhold, PhD, senior vice president and head of global clinical safety and pharmacovigiliance at GlaxoSmithKline, described the data currently available, the criteria a research team must meet to gain access, and the process for obtaining access to the data.
Data availability can be determined by searching the GlaxoSmithKline Clinical Study Register. The initial tranche includes about 200 clinical studies [phases 1 – 4] conducted since January 1, 2007. The Web site will not include observational studies or clinical trials of medicines for which GSK does not have the legal authority to share data, such as those licensed to another company. Dr. Nisen and Dr. Rockhold note that the company anticipates adding studies going back to December 2000 and expects that about 400 studies will be on the Web site by the end of 2013. Investigators will now be able to request access to deidentified patient-level data from some GSK-sponsored trials, but the authors emphasize that obtaining access will be dependent on meeting certain GSK criteria.
"It is important that the analyses proposed by investigators petitioning to access a data set have scientific credibility. We believe that there are public health risks if the proposed analyses are not scientifically robust and give rise to erroneous concerns about safety or false hopes of a potential benefit for patients. Therefore, in accordance with the expectations of usual good scientific practice, investigators will be required to submit a brief research proposal with the use of an online form [Section 2 in the Supplementary Appendix], describing their analysis and publication plans, their management of potential conflicts of interest, and the qualifications and experience of the research team [which should include a statistician]," the authors write.
In an accompanying editorial, Deborah A. Zarin, MD, director of ClinicalTrials.gov and assistant director for clinical research projects at the National Library of Medicine Lister Hill National Center for Biomedical Communications, Bethesda, Maryland, contrasted the GSK controlled-access approach with the open public-access approach to participant-level data noted in an article by investigators from the National Institute of Allergy and Infectious Diseases Immune Tolerance Network, appearing in the same issue of the journals. "The GSK and ITN data policies are bold attempts to modify and improve the process by which research is reported. We have to learn as much as we can from these experiments about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer’s altruism," Dr. Zarin said.
In my opinion, it’s a lie. The process they outline assumes that someone might want to see their clinical research data to use it for further scientific study, a concept popularly discussed as data sharing. While some people might want to do that, do some kind of other research project using their data, that’s hardly in my mind or the minds of the people clamoring for data transparency. What we want is to have the right to check their work directly. The reason is very simple. They have a track record of regularly distorting results by manipulating the tools of science and hiding the things they don’t want us to see. This blog and countless others are filled with examples: Study 329, Study 352, etc. and GSK has been a prime mover in the field of distortion.
They claim to be motivated by a need to protect their research subjects and the potential consumers using their medications. They evoke the gods of "usual good scientific practice." We want data transparency for those same reasons. When they say as they did in Study 329 that "Paroxetine is generally well tolerated and effective for major depression in adolescents," we want to be able to look at the data they base their conclusions on, not some wrapper that goes around the data to hide its meaning, written by some professional writer with a flair for spin. One of the things they’re worried about is that their competitors will take the data and use it to trash their products. That might well happen. But if their data is solid, they will prevail. We’ll even help them. Doctors want decent medications for their patients. We’ll write blogs denouncing their false critics. But if their competitors are right, so be it. They are claiming a right that they gave up when they flooded our literature with too numerous to count deceitful studies.
This time last year, I had this thought, "… the only reason I can think of for keeping the raw data from clinical trials secret is to make distortion possible…" [to make distortion possible…]. I still think it’s right…
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