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November 17, 2015.
Pharma and biotech companies are working with academics and health care organizations to establish systems for collecting and sharing the results of clinical trials, but they have far to go, according to a recent analysis of industry adherence to data transparency requirements. A report from the non-profit Bioethics International finds that for a group of new drugs approved by FDA in 2012, large pharma companies fell “below legal and ethical standards” for making public information from the relevant clinical trials. This disappointing performance raises important ethical issues about patients’ rights in clinical research, the authors state, and could undermine the adoption of personalized and evidence-based medicine.
The study, which was published Nov. 12, 2015 by the British Medical Journal [http://bmjopen.bmj.com/content/5/11/e009758.full?sid=ae78878f-12f0-41a0-8852-45a390a9c0a2], cites a notable lack of transparency at Gilead Sciences for data supporting its HIV therapy Stribild and at Sanofi for a low disclosure rate for Aubagio to treat multiple sclerosis. At the same time, GlaxoSmithKline, Johnson & Johnson and Pfizer did better, disclosing all trial results for at least one new drug reviewed that year.
To encourage industry improvement, Bioethics International is launching a “Good Pharma Scorecard” that ranks biopharmaceutical companies on key ethical and public health criteria, beginning with R&D and clinical trial transparency. The project aims to expand from the 12 companies and 15 new drugs in the current study to include additional drugs and sponsors.
Biopharma companies consider the 2012 performance data outdated, considering extensive industry efforts to expand clinical data sharing, which was discussed last week in a webinar on clinical data sharing presented by the Food and Drug Law Institute. Sponsors are working with independent entities to facilitate access to study results by legitimate researchers, by patients participating in clinical trials, and by the public. Pharma companies also have committed to seeking publication of the results from all clinical trials, including those in discontinued research programs, said Jeffrey Francher, vice president and senior counsel at the Pharmaceutical Research and Manufacturers of America (PhRMA).
Johnson & Johnson vice president Sandra Morris described how the Yale Open Data Access (YODA) project has vetted 25 proposals from outside researchers in the past year to access J&J study results and approved 23 of them. Similarly, the Multi-Regional Clinical Trials (MRCT) Center of Harvard and Brigham and Women’s Hospital continues to build its data sharing and transparency program, with an eye to establishing a centralized, international, non-profit organization that can maintain a sustainable data-sharing platform. MRCT executive director Rebecca Li outlined efforts by working groups to develop governance policies, IT systems and business models for the program, which will be discussed further at a March 2016 conference in London.
Consent & privacy
A key challenge in providing public access to clinical trial data is to protect the privacy of participants in research studies. Even where data is aggregated or de-identified, sponsors have to be on guard against data re-identification potential, particularly with trials of highly targeted therapies for small patient populations. While companies are looking to clarify future-use policies going forward, obtaining patient consent to release their data retrospectively is “a real issue,” noted Francer of PhRMA.
Informed consent policies and procedures thus need to make study participants fully aware of the implications related to consenting to future use of their data and tissue samples. The MRCT group is looking to standardize language for informed consent, as well as methods for determining if there are situations where the benefits of transparency for science and research may outweigh the risks of patient re-identification.
At a minimum, individual participants should be informed of study outcomes and should have access to the results from their participation in a research project, even if such limited transparency has the potential to disclose confidential information. The White House Precision Medicine Initiative (PMI) recently unveiled “privacy and trust” principles for enhancing participants’ access to the medical information they contribute to biomedical research. While the program aims to permit access and sharing of its data, it acknowledges that such access may depend on data type, proposed use, and user qualifications. It also states that all users of PMI data are expected to publish or make public a summary of their research findings, regardless of outcomes.