Synergy in Action

Utilizing Artificial Intelligence and Machine Learning for CNS Clinical Trials

Chairs: Larry Alphs, MD, PhD; Adam Butler

Upcoming Activity: Digital Biomarkers Decision Process Subgroup Working Group Meeting, 2022 Autumn Conference, 8-9 September 2022, Boston MA: The purpose of the working group is to develop a decision tool which will provide a roadmap of the decision process for the selection and use of digital biomarkers in clinical research. A literature review related to digital biomarker applications in CNS trials will be conducted to create the foundation for the decision tool. The group will establish the key factors to consider when evaluating this approach in terms of objectives, opportunities, barriers to adoption, deliverables, and participant acceptance. (Subgroup chairs: Diane Hoffman, Vikas Sharma)

Current Deliverables: Placebo subgroup manuscript accepted for publication. Two subgroups will hold ongoing calls for development of manuscripts (Biomarkers and Outcomes).

Most Recent Activity: Digital Biomarkers Working Group meeting, 18th Annual Scientific Meeting, 23-25 February 2022, Washington DC

Working Group Session – 2020 Autumn Conference – Virtual working group meeting, 22 October 2020 – view summary. View video invitation

Working Group session– 16th Annual Scientific Meeting, Wednesday 19 February 2020, Washington DC – Summary

Inaugural Working Group session-  2019 Autumn Conference includes Joint Day with ECNP View Presentation and Summary, 7 September, 2019, Copenhagen, Denmark

Working Group Deliverable:
Comment on FDA Proposed Regulatory Framework for Modifications to Artificial Intelligence-Machine-Learning Based Software as a Medical Device (SaMD) (June 2019)