Clinical Trial Disclosure & Data Transparency – The Expanding Global Environment

Tutorial:  September 16*
Meeting Dates:  September 17-18

*Tutorials require registration and are an additional fee

Transparency of clinical trial information is taking on new dimensions, including the release of anonymized participant-level data and return of results to study participants. Clinical trial sponsors and academia are facing a host of new registration requirements in the US and EU. Organizations, such as the Institute of Medicine, WHO, and NIH are calling on both industry and academia to share their clinical trial data. Industry’s initiatives on data sharing are also expanding.  This increased transparency and use of information from clinical trials brings with it new data use opportunities and operational challenges for industry and academia.

The continuing expansion of disclosure requirements in the US and EU leave many sponsors and academia considering disclosure strategy, developing operational measures, and looking for efficient ways to manage dissemination of clinical trial protocol information and results data. The users of clinical trial information is varied which provides both opportunities and challenges for how the information is provided.

Just Announced: Dr. Robert M. Califf, MD, Deputy Commissioner, Office of Medical Products and Tobacco, FDA will be delivering the closing keynote address.

This program has been developed in collaboration with the Clinical Trial Disclosure Community.