With the introduction of new clinical trial transparency regulations around the world, transparency functions have had to adapt to a range of reporting requirements. In 2007, the FDA Amendments Act (FDAAA) established requirements for trial sponsors to reveal trial results to participants and patients, physicians, and independent researchers. Since then, more requirements have emerged, including anonymisation and publication policies introduced by the EMA and Health Canada. Going beyond regulatory compliance, transparency leaders have launched voluntary data-sharing initiatives to enable researchers’ access to structured individual patient data. With this move toward greater transparency and the drive for more data, transparency functions working with the clinical trials environment need a broader toolkit of capabilities, including anonymisation, to protect participants’ privacy. The authors explored these emerging trends in a webinar for FDANews on July 23, 2020 (https://www.fdanews.com). FDANews has an 80,000-person database, mainly from the clinical trial space. This article summarises the webinar.
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