Durham, North Carolina
5th December 2019
New Pathways to Approval
New pathways to approval – study/program designs that use methodologies other than traditional Phase I to III randomized trials. The FDA recently published a guidance about this, encouraging sponsors to use non-traditional approaches such as master protocols and basket protocols.
Does the FDA Need a Reboot? – Chris Decker, d-wise
The Power of Sharing Clinical Data: Developing an External Control Arm for Registration – Mike Litzsinger, Project Data Sphere
Guidance for Industry – Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Cancer Drugs and Biologics – Lee Pai-Scherf, FDA
Representing Master Protocols: What Can and Can't be Done Using the CDISC Trial Model – Diane Wold, CDISC
Quality-based Drug Development – Traditional Versus Non-traditional Clinical Trials in the Context of 21st Century Novel Clinical Research – Srinivasa Rao Mandava & Cheryl Simon, Merck
Clinical Trial of the Future: Technology-driven Innovation in Clinical Research – David Hall, Rho
New Data Pathways: Mobile and Wearable Devices – Eric Harvey, MMS
View the event brochure.
Photos of the day: