The Roadmap for Making Clinical Trials More Diverse and Representative

Karla Feghali Co-Author
Deloitte
 
Laura Fernandes Speaker
COTA Healthcare Inc.
 
Monday, Aug 5: 2:45 PM - 3:05 PM
Invited Paper Session 
Oregon Convention Center 
We need clinical trials with a patient population that mirrors real world use to accurately represent the safety and efficacy of drugs but unfortunately most trials fail to achieve this goal. This presentation will start with a brief overview of the current trends in drugs approvals and the regulatory guidance on diversity in clinical trials. Different strategies and efforts by the industry to improve diversity and the tools for alternative clinical trial designs will then be presented. The use of real-world data in clinical trials and decentralized clinical trials where patient burden for participation is reduced will be also be explored.