|
Differences Between the Clinical Study Results Database And a Clinical Trials Registry
There are important distinctions between a clinical study results database and a
clinical trials registry, although both can be critical resources for
physicians, patients and others seeking information about drug products. These
two concepts often are confused, but it is important to separate them when
discussing clinical trial publication and disclosure.
A clinical trial registry provides patients and physicians with
information about ongoing clinical trials that are open and recruiting patients.
An example of a clinical trial registry is the government-sponsored database,
which is accessible at www.clinicaltrials.gov. This is a central registry of
trials for all serious and life-threatening diseases and conditions, operated by
the National Institutes of Health. PhRMA strongly supported establishing this
registry and has actively encouraged our member companies to participate.
A clinical study results database is designed to improve accessibility
to, and transparency of, the results of clinical studies. This electronic
database is a central, standardized repository for published and unpublished
clinical studies that have already been completed. This industry-sponsored
registry will provide access to the results of all hypothesis-testing clinical
studies of marketed drugs — regardless of outcomes.
PhRMA has long led efforts to make meaningful information both about clinical
studies and clinical study results more widely available, and it is committed to
expanding these efforts. This is another way PhRMA members are fulfilling their
commitment to communicate meaningful clinical study results.
|