In May of 2023, the FDA released a new Draft Guidance on decentralized clinical trials (DCTs) that offers recommendations for trial sponsors as they navigate the incorporation of virtual trial elements, ushering in a new era of innovation.
The FDA recognizes that DCTs offer significant benefits and recommends the use of virtual conduct to help increase diversity and inclusiveness in trial populations, stating that "remote clinical trial visits and clinical trial-related activities are important strategies to make trials more convenient and more accessible to trial participants."
In this on-demand webinar, listen to Science 37 and a group of clinical trial experts discuss ways to implement DCTs that align with regulatory guidelines.
Key Learning Objectives
- Deliver study execution and oversight to meet regulatory guidelines
- Expand patient recruitment beyond traditional research sites
- Leverage local HCPs for trial-related procedures
Jonathan Cotliar, MD, Chief Medical Officer, Science 37
Irena Lambridis, Global Head of Quality Assurance and Compliance, Science 37
Krystyna Kowalczyk, Chief Executive Officer, OncoBay Clinical
Amy Bohn, Director, DCT Operations, Bayer