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Synergy in Action

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, 2022 Autumn Conference, 8-9 September 2022, Boston MA: The ISCTM/ECNP COVID-19 CNS Clinical Trial Methodologies Blueprint WG was created to navigate the COVID-19 disruption and unfold its transformative potential in clinical trials methodologies. The working group will meet to finalize guidelines for trial design modifications to assist sponsor companies in minimizing risks to data integrity, with a focus on regulatory, technological, operational and methodological issues related to COVID-19. The guidelines will be published in a manuscript to inform trials impacted by future public health emergencies or natural disasters.

Most Recent Activity: Working Group Session, 18th Annual Scientific Meeting – view slides – 23-25 February 2022, Washington DC

Working Group Session – 2021 Autumn Conference includes joint day with ECNP view slides. The COVID-19 CNS clinical trials methodologies blueprint WG convened to discuss key learnings from the speaker sessions, in addition to ongoing manuscript strategy and next steps.

Working Group Session, 17th Annual Scientific Meeting-View Summary, 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:

  1. 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
  2. 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
  3. 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.