Patient-Centric 2.0: Are We Ready for Decentralized Trials?

10:00 AM - 10:55 AM, Thursday, June 11, 2020 ・ Track Purple (Pacific Time zone listed start time)
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Now more than ever, many different technologies offer the possibility of bringing the clinical trial to the patient. Decentralized trials can be truly patient-centric by easing trial participation and encouraging collaborative drug development. Sponsors will be able to bring medicines to market faster by increasing patient recruitment and retention rates, offering quicker multi “site” launches and providing access to real-time data.

Although attractive, decentralized trials pose many challenges. Panelits will seek to address these growing concerns: Will regulators require "approved" apps and wearables to capture patient data? How many tools will a patient be required to use? Will patients “adhere” to study protocol requirements? What are the implications for patient privacy?
Group Director, US Regulatory Policy
Covington & Burling
Vice President of Services and Supports
Autism Speaks
FDA Officer, Clinical Research Methodology, Regulatory Compliance & Policy Development
Food and Drug Administration, Center for Drug Evaluation and Research