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PhRMA’s Position on Clinical Trials and Communication of
Clinical Trial Results
PhRMA’s commitment to transparency is not new — PhRMA and its member companies have
a longstanding commitment to ensure that physicians and patients
have access to all relevant information about the medicines we discover,
consistent with regulatory requirements, so that our products can be used safely
and effectively. In 2002, PhRMA issued its Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results. These
Principles, supported by our board of directors — the leaders of America's major
pharmaceutical companies – express the commitment of our members to provide
useful and meaningful results of clinical studies (clinical trials), whether
those results are positive or negative.
PhRMA’s commitment is reflected in the 2002 Principles — PhRMA’s
Principles clearly state: “We commit to timely communication of meaningful
results of controlled clinical trials of marketed products or investigational
products that are approved for marketing, regardless of outcome (Section 4.a. on
page 19)." The Principles explain that this includes “the results of all
hypothesis-testing clinical trials [our members] conduct, regardless of
outcome….” Copies of the Principles are available from the Communications
Department at PhRMA.
PhRMA is committed to expanding these efforts — PhRMA has now taken
additional steps to improve transparency of clinical studies on marketed pharmaceuticals by
creating an industry-sponsored database, the Clinical Study
Results Database (www.clinicalstudyresults.org). Such a database is consistent
with the PhRMA Principles, and is separate from a registry of ongoing studies.
Most importantly, it will make these results more transparent and user friendly
for physicians.
Read PhRMA’s Principles of Conduct of Clinical Trials and Communication of Clinical Trial Results.
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