On August 2nd, H.R. 6272, the “Trial and Experimental Studies Transparency (TEST) Act of 2012” was introduced in the House. TEST would amend the Public Health Service Act to expand the clinical trial registry data bank. Among other requirements, the bill would require all foreign clinical studies to meet the same requirements as domestic trials (if used to support an application for U.S. marketing).
Also, the bill would require that results from most covered trials be posted on the registry data bank within one year of the “primary completion date” of the trial. Delayed submission of results up to two years after trial completion would be allowed for trials on drugs of devices that have no previous history of approval for use. The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) would be instructed to provide Congress with a report on the implementation of and compliance with the database requirements.
The amendments the bill would make to the Public Health Service Act would help to protect those individuals enrolling in clinical trials in a number of ways. For instance, the requirement of public access to expanded clinical trial data would help to eliminate the possibility of hiding negative study results. This could help to prevent potential harm to future participants of a different company’s clinical trial for the same type of drug that had caused harm in an earlier trial.
On the other hand, the bill could be seen as a barrier to industry-sponsored clinical trials. For example, public release of critical results and data could reveal proprietary information to competitors. Having the ability to keep data private may allow drug and device companies to go back and improve upon their product, without having revealed—to shareholders, competitors, and others—work done in earlier stages.
While fierce competition will always remain among drug and medical device companies, new regulations such as the TEST Act can serve as a referee of sorts for industry that helps to assure protection of the public’s welfare. By taking the steps required to publicly share the successes and failures of clinical trials, drug and device companies may learn more from one another’s results, leading to an enhanced global effort to indirectly work together to better the overall industry.©2013 Drinker Biddle & Reath LLP. All Rights Reserved