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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.
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