Press Release


For Immediate Release Contact

 

Sue Ducat
Director of Communications
(301) 841-9962
sducat@projecthope.org

   
Transparency in Clinical Research
 

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation examines past and present initiatives to improve the use of clinical research for patients, providers, and health systems. According to one estimate, up to half of all completed clinical trials have never had their results published--especially those that did not have positive findings. Furthermore, a significant percentage of trials used by drug companies to support their approval applications to the Food and Drug Administration (FDA) were not made publicly available. Some companies have failed to adequately report study findings to regulatory agencies, resulting in fines. Although previous efforts to address these issues have failed, recent policy initiatives both in the United States and in other countries offer new opportunities to solve some of these problems.

 
Topics covered by this policy brief include:
 
  • What's the background? This section of the brief outlines past and current efforts to increase transparency in clinical research by groups that include the International Committee of Medical Journal Editors, ClinicalTrials.gov, and the FDA. As the brief explains, past efforts achieved limited results for a variety of reasons. The brief also describes current efforts under way to improve access to trial data including those by the AllTrials campaign, the European Medicines Agency, and the Department of Health and Human Services. 

  • What's the debate? There are several key challenges that need to be addressed to ensure that data sharing maximizes public benefit, while minimizing the risks associated with increased transparency. These include the need to protect patient privacy while sharing study results and the risk that trial data will be misused or improperly analyzed. To minimize the latter risk, the brief describes the data-sharing platforms that industry groups have established, which require researchers to submit formal requests to review data and require them to read the data through secure portals.

  • What's next? The 21st Century Cures Act, passed in July 2015 by the House, is now being considered by the Senate. As the brief points out, the Senate has previously developed its own bill aimed at reforming the biomedical research infrastructure, and it remains to be seen how the two versions will be reconciled. At the same time, questions remain regarding the industry-sharing programs of private industry as well as those offered by the European Medicines Agency.