Transparency in Clinical Trials: A New Paradigm Shift?
By Leigh Anderson, PharmD - The British Medical Journal (BMJ), a leading, peer-reviewed medical journal, has announced that beginning in January 2013 it will require all authors of drug or device clinical trials who publish in BMJ - whether industry-funded or not - to provide detailed scientific study data to anyone with a reasonable request. Although the policy specifics are still under discussion, it is expected trial data down to the anonymised patient level would be required. In addition, BMJ will publicize instances in which requests for data were rejected by authors.1
The new BMJ policy is one that will aim to make clinical trial results more transparent, including mid-study protocol changes, negative efficacy outcomes and potentially life-threatening adverse effects. Much industry-driven clinical trial data is never published or otherwise made available to the public. In a recent editorial, BMJ editor-in-chief Fiona Godlee asks why this is so? Why should drug companies be allowed to evaluate their own products prior to regulatory approval, and then keep large amounts of secretive data from the regulators? Why should it be up to the pharmaceutical companies to decide who sees the data, and for what purpose? 2 Pharmaceutical companies claim the data is proprietary and its release could prompt an unfair market advantage to competitors. Others in the medical world feel publically sharing the data sets could serve to enhance disease research, fortify drug development and most importantly, strengthen patient safety.
Researchers at John Hopkins University School of Medicine in Baltimore, and members of the Cochrane Collaboration - a global group that develops systematic healthcare reviews utilizing an evidence-based approach - support the new BMJ policy. In addition, GlaxoSmithKline (GSK), Britain’s top drug company, spoke out in favor of the BMJ’s decision. Just three weeks earlier, GSK had announced their plans to allow secured web access to anonymised, patient level data via an independent panel that would review and approve requests. GSK will also make their tuberculosis compound libraries publicly available, as they did in 2009 with their malaria compounds, to foster knowledge sharing and medical advances for these deadly diseases. In years past, GSK has posted results -- whether positive or negative -- in a clinical trial registry, but without access to the detailed data. Now it appears GSK is boosting its efforts towards clinical trial openness following years of legal battles involving study and marketing improprieties linked to many compounds, including Paxil (paroxetine) and Avandia (rosiglitazone).3,4
However, not all members of the healthcare community are so motivated by BMJ’s new rules. Pharmaceutical Research and Manufacturers of America (PhRMA), a group that represents the leading U.S. pharmaceutical research and biotechnology companies, voices a concern about misinterpretation of data, breaches of patient confidentiality, and loss of proprietary information.1 PhRMA does submit basic clinical trial data to a federal website and states that they support transparency. A significant difference going forward will be the availability of detailed, anonymised patient data, which is bound to generate dialogue.
Clinical trial registries are freely available from several sources, but not down to the level of patient data. Clinicaltrials.gov is a clinical trial registry and results database developed through the National Library of Medicine. As of August 2012, ClinicalTrials.gov contained over 130,000 U.S. and international clinical research studies that are available for clinicians and the public to search.5 Clinical trial registry and summary information of FDA-approved medical products are freely available independent of journal publication status; however, some experts suggest even the full reliability of this database is in question.
A paradigm shift in clinical trial transparency leaves new questions to be answered. Will other peer-reviewed journals follow BMJ’s lead and require transparency from all clinical research authors? Will transparency boost the quality or lower the publication rates of industry-sponsored trials? Will the larger scientific community truly be able to gain access to the data through “independent” panel reviews? Can patient-level data remain secure? And most importantly, will individual patient care and safety be improved? These matters, and others, will be important to answer as the debate towards clinical trial openness and transparency evolves.
- Thomas K. (2012, October 31) Medical journal to require more details on drug trials.” The New York Times. Accessed November 17, 2012.
- Godlee F. Clinical trial data for all drugs in current use. BMJ 2012;345:e7304. Accessed November 17, 2012.
- Teather D. (2004, August 27) Spitzer forces Glaxo to publish drug trials. The Guardian. Accessed November 17, 2012.
- Grayling L. (2012, October 15). GlaxoSmithKline to Share Data from Clinical Trials with Other Researchers. Drugwatch. Accessed November 17, 2012.
- ClinialTrials.gov. About the results database. Accessed November 17, 2012.
Posted: December 2012