ISCTM/ECNP Joint COVID-19 CNS Clinical Trials Methodologies Blueprint
Chairs: Kemi Olugemo, MD; Dragana Bugarski-Kirola, MD; Gerard Dawson, BSc, DPhil
Upcoming Activity: Working Group Session, 17th Annual Scientific Meeting, 7 April 2021
INAUGURAL MEETING: December 2020
The unprecedented outbreak of the COVID-19 pandemic has quickly altered everyone’s life and forced us to re-think our practices, adopt safe ways to operate and adopt emerging technologies to address the upcoming challenges in clinical trials. Thus, there is a rising need to join forces and explore all possible ways to mitigate the impact of COVID-19 in clinical trials while attempting to advance our approaches and capabilities to bring new medicines to patients.
We invite you to join the ISCTM/ECNP Joint COVID-19 CNS Clinical Trial Methodologies Blueprint Working Group in a joint journey to navigate the COVID-19 disruption and unfold its transformative potential in clinical trials methodologies.
The objectives of the working group are to:
- Determine the effect of COVID-19 on analysis and interpretation of CNS clinical trial data (safety endpoints, efficacy endpoints, rater training, in clinic and remote monitoring through digital technology, e.g., sensors/wearables, apps) using 3 diverse disease states as specific examples
- Describe impact of direct effects as well as post-COVID syndromes on CNS clinical trials (neurological manifestations, NEURO-COVID, depression, anxiety, PTSD, etc.) to inform the COVID-19 session at the Fall 2021 joint ISCTM/ECNP meeting
- Develop guidelines for trial design modifications to assist sponsor companies in minimizing risks to data integrity
Findings from the working group will inform the COVID-19 session at the Autumn 2021 Joint ISCTM/ECNP Conference 30 September – 02 October (Autumn 2021 Joint Conference Agenda at a Glance), as well as a manuscript detailing recommendations for management of regulatory, technological, and methodological issues related to COVID-19.