Utilizing Artificial Intelligence and Machine Learning for CNS Clinical Trials
Chairs: Larry Alphs, MD, PhD; Adam Butler
Digital Biomarkers Decision Process Sub-group: Chairs – Vikas Mohan Sharma, MD; Anzar Abbas, PhD
Upcoming Activity: Digital Biomarkers Decision Process Working Group Meeting, 21st Annual Scientific Meeting, 19-21 February 2025, Washington DC
The working group will convene to continue its work on compiling pertinent information to aid in decision-making with respect to the implementation of digital health measures in clinical research.
The working group is organized into four subgroups:
1. Glossary: Establishing standardized terminology in the field of digital health measurement
2. Clinical Validation: Defining criteria for evaluation of the clinical validity of a novel measure
3. Clinical Operations: Highlighting operational/UX considerations when implementing digital health tools
4. Regulation: Collating and presenting information on available regulatory pathways for novel measures
In this gathering, each of the subgroups will be presenting updates on the work carried out since the previous Annual Meeting and the next steps. The co-chairs will lay out a plan for final deliverables.
Most Recent Activity: Digital Biomarkers Decision Process Working Group Meeting, 20th Annual Scientific Meeting, 21-23 February 2024, Washington DC – View summary, view slides
Current Deliverable: Subgroups are collaborating to develop a digital biomarkers decision process tool.
Recent Activity: Digital Biomarkers Decision Process Subgroup Working Group Meeting, 19th Annual Scientific Meeting – view slides and summary, 15-17 February 2023, Washington DC
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. In Feb 2023 meeting, the WG will come together to identify the key work packages needed to support the objectives of the group, assign leadership and accountability to the respective work package streams and agree on timelines and next milestones. (Subgroup chairs: Diane Hoffman; Vikas Sharma, MD)
Digital Biomarkers Decision Process Subgroup Working Group Meeting, 2022 Autumn Conference – view summary, 8-9 September 2022, Boston MA (Subgroup chairs: Diane Hoffman; Vikas Sharma, MD)
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 Deliverables:
Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials
Comment on FDA Proposed Regulatory Framework for Modifications to Artificial Intelligence-Machine-Learning Based Software as a Medical Device (SaMD) (June 2019)