The medical research enterprise produces a massive amount of information that is critical for effective medical care, public health, innovation, and sound public policy. Yet only a fraction of this information is actually captured. Thus, for example, recent studies show that 17% of healthy volunteer phase 1 trials are published in scientific journals, whereas only 43% of phase 2 to 4 trials are published. Moreover, the trials that ultimately get published are not a random sampling of all the conducted trials. Rather, investigators and journals are biased towards publishing positive results. Famously, Peter Doshi and colleagues describe how documents unearthed through cumbersome processes dramatically altered the clinical utility picture for the influenza drug Tamiflu. They also describe the stonewalling by Roche and regulators when trial reports were sought. A real travesty.
In a 2012 report in JAMA “Clinical Trial Data as a Public Good,” Rodwin and Abramson argue for greater transparency in clinical trial reporting practices and suggest mandating the disclosure of standardized Clinical Study Reports (CSR) for all clinical trials. These CSRs are the documents that drug manufacturers produce in order to meet international and national regulatory requirements, which the authors contend are less likely to contain altered data than trials published in journals. The authors argue that mandatory disclosure would promote research integrity, is more reliable than other published summaries, and would ultimately reduce biases in biomedical research. They further justify CSR disclosure by claiming that clinical trials are public goods used by many different actors and that large public subsidies go towards supporting the drug industry in the form of drug patents, public drug insurance plans, and R&D subsidization. We can’t think of any good policy or ethical reasons why this proposal shouldn’t be implemented. We also think academic medical centers and public funding agencies should use their muscle to demand that sponsors commit to public reporting for all studies directly and indirectly within their jurisdiction.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.