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Activity Number:
262 - Biopharmaceutical Section A.M. Roundtable Discussion (Added Fee)
Type: Roundtables
Date/Time: Tuesday, July 31, 2018 : 7:00 AM to 8:15 AM
Sponsor: Biopharmaceutical Section
Abstract #330297
Title: Clinical Trial Data Transparency and Patient Privacy
Author(s): Darcy Hille* and T. Ceesay and Jonathan Hartzel
Companies: Merck & Company Inc and Merck and Merck
Keywords: clinical study report; transparency; privacy

The pharmaceutical industry is under pressure from regulators towards increasing clinical trial data transparency. In 2018, the FDA launched a pilot program under which it will post certain information contained in clinical study reports (CSRs) on its website. (CSRs are company-generated summaries of clinical trial results.) The CSRs must be redacted to protect patient privacy. Likewise, when patient level clinical trial data is shared with researchers, it must be anonymized. We will discuss the challenges of increasing the transparency of clinical trial results and data while protecting the privacy of individual participants in the clinical trials.

Authors who are presenting talks have a * after their name.

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