BIO Releases its Principles on Clinical Trial Data Sharing
With the joint release and agreement of the PhRMA and EFPIA on those organizations clinical trial data sharing and transparency principles, BIO has releases its own Principles on Clinical Trial Data Sharing.
With the joint release and agreement of the PhRMA and EFPIA on those organizations clinical trial data sharing and transparency principles, BIO has releases its own Principles on Clinical Trial Data Sharing. Similar to the pharmaceutical members companies of PhRMA and EFPIA, BIO companies agree to the following:
1. 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).
2. Summarizing the Results of Clinical Trials: BIO member companies will post technical summary results in a clinical trials database, with caveats.
3. Publishing Clinical Trials: BIO member companies will submit for publication in the scientific literature, or otherwise make available to the scientific community.
4. Providing Factual Summaries of Clinical Trials to Research Participants.
5. Responsibly Sharing Additional Clinical Trial Data. The difference here is that BIO member companies will develop and make public its procedures for this process, unlike the PhRMA/EFPIA principles, whose members companies agree to have requests reviewed by a separate scientific review board not employed by the company.
Read the full release here.
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