Moving the Needle on Innovation in Clinical Trial Designs and Strategies: Vignettes of Statistical Leadership and Lessons Learned from a Global Pandemic

• Activity Number: 227 - Moving the Needle on Innovation in Clinical Trial Designs and Strategies: Vignettes of Statistical Leadership and Lessons Learned from a Global Pandemic
• Type: Invited
• Date/Time: Tuesday, August 9, 2022 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Pandurang Kulkarni* and Chris Miller* and Wayne Wisemandle * and John Scott* and Lisa LaVange*
• Companies: Eli Lilly and AstraZeneca and Pfizer and FDA and U of North Carolina
• Keywords: pandemic; innovation; clinical development; leadership; collaboration; strategy

Abstract

The global pandemic has forced the industry and clinical researchers to re-evaluate vaccine and drug development as well as develop new ways to collaborate. Effective and strategic partnerships are critical during this pandemic to enable innovative clinical trial designs and methods, data sharing, as well as standardization of clinical outcome assessments for regulatory decision making. Lessons learned from the acceleration of COVID vaccines and therapeutics development leveraging tactics such as cross-sector collaborations, master protocols, and Bayesian designs for continuous learning will continue to influence clinical development beyond the pandemic and across therapeutic areas. The speakers will describe their experiences on the statistical and operational challenges, approaches that have and have not worked, and speak to how the statistics community play a vital leadership role in transforming vaccine and drug development moving forward.