- Defining Clinical Trial Transparency
- Clinical Trial Spin and Suppression
- Benefits and Costs of Transparency
- Legislative Strategies to Encourage Transparency
- Bottom-Up Strategies for Clinical Trial Transparency
- Conclusions: Towards Greater Transparency
- Clinical Trial Transparency References
Legislation, including the FDAAA of 2007, does appear to be leading to greater transparency in clinical research. Legislation is relatively slow to modify, however, and its passage may be affected by the lobbying from the large and influential pharmaceutical industry. A potential alternative approach to encouraging transparency may come from a recognition that the performance of clinical trials depend fundamentally on the voluntary participation of patients as research subjects, physicians who recruit patients and execute the trials, and the institutions that enable and provide permission, through Institutional Review Boards, for trials to occur. The individual doctors who ultimately carry out clinical trials could insist on greater data transparency before agreeing to clinical research contracts. In fact, if only a few individual doctors chose to refuse to conduct clinical trials without guarantees of transparency and submission of results to public database, they might exert considerable public relations pressure on the industrial sponsors, without necessarily causing disruption to the entire clinical research enterprise, as might occur if a large institution immediately adopted a similar position. However, institutions do have a responsibility to help coordinate and legitimize these grassroots efforts to increase transparency. Even a small institution could exert a significant influence by developing policies requiring that clinical trial investigator agreements. Most institutions already provide checklists for investigators that must be signed off before and investigator joins a clinical trial; these checklists could be extended to make investigators more aware of trial data submission policies.
Patients could also exert a much greater influence on the clinical trials to which they subject themselves. Informed consent should include information not only about the purpose and risks of a trial, but also information about outcomes. HIPAA protects the information about patients that is stored electronically, and requires patient consent to use or transmit. Under HIPAA, patients have access upon request to all of their own medical records that are stored electronically. These health records include the results of clinical trials. By default under HIPAA, patients will also have access to their own clinical trial data, unless a patient explicitly agrees to give up access while the trial is underway. It is reasonable that patients should give up access for the duration of a trial; after the trial is complete, however, all medical information should be accessible. Individual rights to information thus provide a route to clinical trial transparency that does not depend on the cooperation of trial sponsors, or even of clinicians. Patients simply need to be better informed of their rights and refuse to contractually give up access to personal data when granting informed consent. If patients could access records after a trial had concluded, they could choose to make their own data available. Since the information is accessible electronically, these records could be potentially be re-aggregated by third parties for analysis without further participation or cooperation of the trial sponsors.