A notice published in the Federal Register for Wednesday, September 26, 2012 reported the delegation of authority to the Commissioner of Food and Drugs to police the submission of clinical trial information to ClinicalTrials.gov, as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
As noted in several articles that appeared earlier this year in the British Medical Journal, relatively few clinical trials fully comply with mandatory reporting requirements, and publication in peer-reviewed journals is inconsistent. Publication bias – the tendency of sponsors, journal reviewers and editors to favor trials with positive findings – is also an ongoing concern. As a result, there are huge gaps in publicly available knowledge of clinical trials and their outcomes.
A bill recently introduced by US Congressman Ed Markey, D-MA, the Trial and Experimental Studies Transparency (TEST) Act of 2012, proposes to expand mandatory registration and reporting to include all interventional trials that are submitted to FDA in support of any type of marketing application for a drug, biologic or device. (“Interventional” means participants’ treatment assignment is dictated by the research protocol, as opposed to clinical judgment or the current standard of care.) The bill would also add supporting documents including the IRB-approved consent form and protocol to the information that must be submitted before enrollment begins.
Meanwhile, the Ethical Pathway Act of 2012, introduced by US Senator Bernie Sanders, I-VT, seeks to reduce unnecessary duplication of effort in clinical research. Another House bill introduced by Congressman Brian Bilbray, R-CA, the Patient Choice Act of 2012, would create a fast-track provisional approval process for lifesaving therapies. Provisional approval would depend on the availability of clinical data to support an FDA finding that a product is “adequately safe” in at least one patient population. A stronger and more comprehensive ClinicalTrials.gov will be of great importance if these two measures become law.
