Table 4 Strategies for Sites to address extenuating circumstances in an ongoing clinical trial

Key strategies for sites to manage extenuating circumstances in an ongoing trial

1: Learn about institutional policies for research and assess how the policies apply to each study and circumstances. This knowledge will help the site and Methods Centre plan for how best to optimize retention and fidelity.

2: Communicate with local trial stakeholders before restarting enrolment. Discuss with local study team members about what types of activities can still occur for a given study and the capacity of the site to continue with research within the confines of institutional policy and the current situation.

3: Communicate with the Methods Centre regarding study-limiting institutional policies, site capacity to continue all or part of a research study, patient status, and data cleaning progress. Early and intentional communication will allow the Methods Centres to provide appropriate guidance and support for each site’s specific circumstances.

4: Use materials developed for the extenuating circumstances to develop strategies for ongoing trial conduct. For complex studies involving multiple personnel, it is helpful to know staff availability to ensure the protocol is delivered as intended. Much can be learned from times of crisis and contingency plans are good practice, even outside pandemic times.