The Pros And Cons Of Publishing Non-Interventional Study Data – As Seen By Sanofi & GSK

The increasing scientific importance of different types of non-interventional studies with a unique set of data elements has encouraged some companies to opt for their voluntary disclosure beyond current requirements. Executives from Sanofi and GSK share their experiences and ongoing challenges.

clinicaltrials.gov
Ethic Committees Expect Non-Interventional Studies To Be Listed On A Public Registry • Source: Alamy

When it comes to research transparency, most jurisdictions have clear legal requirements for sponsors to disclose information on clinical trials, but not for most observational or so-called non-interventional studies (NIS).

However, growing interest in real-world evidence derived from non-interventional studies and its use in regulatory decision-making has prompted some companies...

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