Output

Meetings
Over the course of the year, the Clinical Outcomes in Early-Phase Clinical Trials Thematic Working Group (TWG) organises webinars at which its members and affiliates can discuss specific topics of interest and promote alignment in terms of goals and deliverables. New experts are welcome to attend.

In 2023, additional SMART sessions will be conducted to cover completed COS projects that are relevant to our goals. Additionally, Seed Sessions will be scheduled throughout the year to discuss the application and feasibility of COS/COA projects in specific fields to identify areas with unmet needs as clearly as possible. Any researcher can apply to lead a seed session by proposing a specific application to the TWG.

Group platform
A common working space for TWG core members and affiliates where we share working documents pertaining to COA science in CNS:
CNS-Core-Outcomes-Set

Guidance document
In 2021, the TWG published a consensus guidance document for COA selection that serves as a reference. This document provides guidance for sponsors aiming to design interventional studies and is updated twice per year to account for advances in methodology and novel regulations by health authorities.

Recommended publications

Other

• P.426 'Standards for designing optimal Outcomes strategies for drug development – Survey on the challenges in neurosciences' presented at the ACNP 62^nd Annual Meeting
• P.492 'Improving the efficiency on the selection of clinical outcomes assessment tools in early stages of clinical trials' presented at the 33^rd ECNP Congress Virtual, 12-15 September 2020