Innovative Technologies for Clinical Trials
Chairs: Richard Keefe, PhD; Michael Davis, MD, PhD
Working Group Session – 18th Annual Scientific Meeting – view slides – 23-25 February 2022, Washington DC
Innovative Technologies in CNS Trials – Promises and Pitfalls for Recruitment, Retention and Representativeness – manuscript submitted
Manuscript on placebo in development; group will sunset when manuscript is complete
Working Group Session – 2021 Autumn Conference includes joint day with ECNP – view summary. The WG reviewed the status on the three sections of the manuscript that is in development on the use of innovative technologies to address key issues in clinical trials: patient recruitment; placebo response mitigation; and assessing clinically meaningful response.
Working Group Session, 17th Annual Scientific Meeting, 8 April 2021
Hot Topic: Regulatory viewpoints from EMA and FDA on contemporary challenges and strategies for conducting and analyzing clinical trials in the COVID-19 era, 2020 Autumn Conference
Webinar: 15 May Adapting Trials (In a Hurry) for Remote Assessment Call 3- EMA Perspectives: Link to View Video
Webinar: 17 April Adapting Trials (In a Hurry) for Remote Assessment WG Call 2 – FDA Perspectives: Link to View Video and Questions Discussed
Webinar: 3 April Adapting Trials (In a Hurry) for Remote Assessment WG Call 1: Link to View Video and Call Notes
Working Group session, 16th Annual Scientific Meeting, 21 February 2020, Washington DC
Working Group Session, 7 September 2019, AC Bella Sky Hotel, Copenhagen Denmark View Summary
The Innovative Technologies Working Group is in the early stages of developing a document outlining how innovative technologies may address key challenges in CNS clinical trials as well as the scientific and regulatory issues that need to be considered.
Working Group Session – 15th Annual Scientific Meeting– 21 February 2019, Washington DC
This working group was developed based upon the all-day session of the same name at the Autumn 2018 meeting co-chaired by Phil Harvey, Rich Keefe, Mike Davis and Tiffany Farchione. The emphasis of this working group will be on an ongoing non-commercial discussion of strategies for providing developing and implementing need-based technologies to help solve current challenges in CNS clinical trials. Conceptual, practical, measurement, statistical, and regulatory issues will be considered in this working group.Regulatory input will be essential to this discussion. The inaugural meeting of this working group will take place at the 15th Annual Scientific Meeting, 19-21 February 2019.