PURPOSE: Clinical outcome assessments (COAs) are often used in clinical trials to assess treatment benefit. A face-to-face element is generally involved during COA development or administration. However, the COVID-19 pandemic has created an altered landscape for use of COAs in clinical trials. The purpose of this workshop is to discuss ideas and best practices for the development, validation, and administration of COAs in clinical trials during a pandemic while considering trial participant safety. Participants will gain an overview of the challenges of administering COAs during a pandemic and hear discussion about addressing these challenges.

DESCRIPTION: A primary challenge with COVID-19 restrictions has been the prevention of in-person data collection, which can be a key part of COA development and administration. Some COAs may be administered virtually with little modification. Other COAs such as certain clinician-reported (ClinRO) and performance outcome (PerfO) measures may be more difficult to administer remotely. These challenges need to be fully considered to ensure that the mode and/or method of administration is suitable and appropriate for the COA and measurement objectives. Changing the administration method during a study also has implications which need to be addressed. Additionally, the potential impact of the pandemic on the concepts being captured requires consideration. Potential issues and proposed solutions will be explored during this workshop, drawing on the presenters’ experiences working on multiple projects during the COVID-19 pandemic in regulatory, industry and consultancy contexts. The implications for future clinical trial design will also be discussed (e.g. remote visits, decentralized trials).