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PhRMA’s Position on Clinical Trials and Communication of Clinical Trial Results


PhRMA’s commitment to transparency is not newPhRMA 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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