NISS Ingram Olkin On-line Forum on Unplanned Clinical Trial Disruptions
Building on sessions 1 & 2 on Perspectives from Statistical Leaders in Government Agencies, topic-specific sessions are planned to start late August 2020. Each session will include presentations by invited speakers' aimed at stimulating working groups. Then participants will form small working groups in breakout rooms to formulate open research problems. It is anticipated that this effort will initiate new collaborations and result in published manuscripts.

Sessions organized around statistical topics that are expected to be useful in responding to the new challenges will include

• Estimand issues and Missing Values (1 or 2 sessions): Confirmed speakers include Mouna Akacha (Novartis Pharma AG), Suzie Cro (Imperial College of London), and David M. Murray (NIH Office of Disease Prevention).
• Randomization Tests (1 session): Confirmed speakers are Michael Proschan (National Institute of Allergy and Infectious Diseases), William F. Rosenberger (George Mason University) and TBA.
• Adaptive Designs (Early Stopping): TBA
• Adaptive Designs (Sample Size Re-estimation): TBA.
Additional sessions are expected to evolve from issues raised. For example, the use of historical data and other sources of external information was raised earlier by Lilly Yue.

The maximum number participants in the breakout working groups will be limited. A registration fee ($25/session, $75/all sessions, no charge to NISS affiliates: https://www.niss.org/affiliates-list) is required to proceed to secure participation.

If you wish to participate in these sessions, please continue to describe your specific interest, so the organizing committee can plan accordingly. We are especially seeking a diverse group of clinical trialists and statisticians with skills to lead discussions and interests in building collaborations for future research.
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