Principles on Clinical Trial Data Sharing Reaffirm Commitment

BIO member companies will honor, at minimum, the following commitments:

REGISTERING CLINICAL TRIALS:

BIO member companies will register all company-sponsored clinical trials conducted in patients in an appropriate public registry, such as ClinicalTrials.gov or the European Clinical Trials Database (EudraCT).

SUMMARIZING THE RESULTS OF CLINICAL TRIALS:

BIO member companies will post technical summary results in a clinical trials database as follows:

  • For approved products, all company sponsored clinical trials testing both safety and efficacy in patients, regardless of whether their outcomes are positive or negative; and
  • For products discontinued in development for all indications because of safety concerns, all pivotal company sponsored clinical trials testing both safety and efficacy in patients, regardless of whether their outcomes are positive or negative.

PUBLISHING CLINICAL TRIALS:

BIO member companies will submit for publication in the scientific literature, or otherwise make available to the scientific community (i.e., on a company-sponsored website, at an appropriate scientific conference, etc.), the results of all company sponsored Phase 3 clinical trials and clinical studies of significant medical importance regardless of whether their outcomes are positive or negative.

PROVIDING FACTUAL SUMMARIES OF CLINICAL TRIALS TO RESEARCH PARTICIPANTS:

BIO member companies will work with regulators to adopt a framework for developing and sharing factual summaries of clinical trial results with research participants.

RESPONSIBLY SHARING ADDITIONAL CLINICAL TRIAL DATA:

For their approved medicines, each BIO member company will fulfill qualified requests from medical and scientific researchers for additional clinical trial data (e.g., Clinical Study Reports, patient level clinical datasets, clinical study designs and protocols, etc.) beyond those shared proactively with the public. To facilitate this process, each BIO member company will develop and make available to the public its own criteria, procedures, and timelines for determining the qualification of specific requests for clinical trial data.

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