Ongoing Trials During COVID-19: Quantitative Strategies and Methodological Aspects
As the evolving COVID-19 pandemic continues, the clinical trial community and regulatory agencies have taken extraordinary measures to mitigate the negative effect the virus has on the conduct of clinical trials. In response to the pandemic, the FDA and EMA drafted guidance on the actions that sponsors of affected clinical trials should take to help ensure the integrity of their studies, and the interpretation of the study results, while safeguarding the safety of trial participants as a first priority.
Watch this virtual panel discussion with regulatory and industry experts, who discuss:
- Challenges and decisions to be made regarding the collection, review and interpretation of data
- FDA and EMA guidance: Interpretations and strategies, evaluation of alternative endpoints and data collection methods, handling of missing information, modifying protocols for efficacy assessments, amending analysis plans
Moderator:
Natasha Muhlemann, Vice President, Strategic Consulting, Cytel
Panelists:
Greg Campbell, Former Director, Division of Biostatistics, CDRH, FDA
Simon Day, Former Manager Statistics Unit, MHRA
Paul Terrill, Principal, Strategic Consulting, Cytel
Rajat Mukherjee, Research Fellow, Strategic Consulting, Cytel
James Matcham, Senior Principal, Strategic Consulting, Cytel, Former VP Early Biometrics and Statistical Innovation, AstraZeneca