BU Study Finds Lack Of Clinical Trial Transparency Threatens Validity

A study by investigators at the Boston University School of Public Health (BUSPH) found that a lack of transparency in clinical trials threatens the validity of clinical research. Published in the journal PLOS ONE, the BU study found that many clinical trial results are not publicly disclosed, even years after study completion. Small studies and those funded by industry are the least likely to be published. Lead author, Dr. Christopher Gill, director of BUSPH's Pharmaceuticals Program, said, "Science learns from mistakes, as well as successes. If we only learn about the scientific success stories, we are really only seeing part of the picture."  

BU Clinical Trial Study

The BU clinical trial study analyzed 400 studies that had at least four years in which to disclose results. They calculated the times from study completion to publishing the primary outcomes. Results showed that 30 percent (118) of the completed trials were not published four years later. The 70 percent that did publish took an average of two years to share data in publications such as journals or the ClinicalTrials.gov (CTG) web site. Industry sponsored studies were published most often from Phases III or IV, but publishing rates for Phase II studies were extremely low.

Dr. Gill analyzed the results saying that there is strong evidence for a reporting bias, which merits consideration. He added that the results reflect varying motivations among researchers. The academic environment differs from industry, as academics heed the "publish or perish" model. Industry’s focus on Phase III results reflects its imperative to find commercially viable drugs. 

FDA Role

Authors suggest that the Food and Drug Administration (FDA) has a role to play in clinical trial publications. For instance, the Food and Drug Administration Amendments Act (FDAAA) of 2007 requires industry to publish Phase III and IV results within one year of completion.

Additionally, the FDA has a role to play in the ethical issues regarding clinical trials. Recently, the federal agency published new guidelines regarding informed consent, asking investigators to inform prospective trial participants that their participation is beneficial to future patients with the same condition. Dr. Gill says that this raises ethical problems, as patients often participate in studies out of “a sense of altruism.” If the results are not published, patients may be disappointed because they took physical risks that may never be known or benefited from.