Increasing Transparency of Clinical Trial Data in the United States and the European Union
Washington University Global Studies Law Review
The Internet is becoming the greatest source of health information for most consumers, which reinforces the importance of making online information about clinical trials accessible in a reliable, unbiased format. Non-reporting and distorted reporting of clinical trials impede the betterment of scientific knowledge and public health.
There have been increasing demands for public transparency and the complete disclosure of clinical trial data. Hoarding data causes researchers to duplicate efforts, repeat mistakes, and potentially cause avoidable injuries or deaths to research subjects. Changes in the administration of clinical trials is necessary to safeguard public health and maximize effective use of clinical trial data.
Since the funds for many clinical trials are supplied by drug manufacturers, who in turn receive large public subsidies, clinical trial data should be considered a public good. Yet drug manufacturers continue to assert ownership and proprietary rights to clinical trial data including clinical study reports (CSRs). They classify CSRs as a trade secret and argue a policy of CSR release advantages the competition
Given the climate of public distrust toward Big Pharma, clinical data transparency is becoming a higher priority item on the agenda of the international community. Part II of this Note provides specifics on the recent developments propelling clinical trial registration and reporting. Part III covers the FDA’s stance on clinical trial disclosure in the U.S. Part IV explains the EMA’s initiative to increase transparency in the EU’s newly passed Clinical Trials Regulation. Part V focuses on public release of CSRs. Part VI sets forth proposed models for access to clinical trial data that address issues of patient privacy and proprietary information. Part VII discusses the need to strike a balance between the conflicting interests of drug manufacturers and public health proponents.
Increasing Transparency of Clinical Trial Data in the United States and the European Union,
Wash. U. Global Stud. L. Rev.