Update from PRIM&R’s Public Policy Committee

by Amy Davis, JD, MPH, Senior Director for Programs and Publications

PRIM&R recently sent comments to Congressman Edward Markey, (D-MA), senior member of the House Energy and Commerce Committee, on a bill called the Trial and Experimental Studies Transparency (TEST) Act of 2012. The goal of the bill is to increase transparency of clinical trials by expanding reporting and registration requirements for ClinicalTrials.gov, an online clinical trial registry data bank.

In his press release about the bill, Rep. Markey argues that current registry and reporting requirements contain loopholes that deny the public full access to clinical trial information. Rep. Markey states that “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.”
Under the new bill, all foreign clinical studies must meet the same registration and reporting requirements as domestic trials if they are conducted in support of a Food and Drug Administration product application. This is a powerful enhancement to the clinical trials registry given the increasing amount of research being conducted overseas.
In its letter to Rep. Markey, PRIM&R expresses support for increasing transparency of clinical trials. We agree that greater transparency will strengthen the public’s trust in the research enterprise. However, PRIM&R cautions that preliminary steps be taken to analyze the efficacy of the current registry systembefore attempting to expand its requirements. PRIM&R argues that if the current structure is not serving the public as intended then “expanding the registration and reporting requirements will do little to further transparency and knowledge.”
As always, we welcome your thoughts. Let us know what you think of the TEST Act and PRIM&R’s letter to Congressman Markey.