CTTI Best Practices for Clinical Trials During COVID-19 Restrictions

4/03/2020

remote site visit telehealth

Clinical Trial Transformation Initiative (CTTI) collected information from clinical trials stakeholders in March during increasing COVID-19 restrictions. An ongoing concern is how to balance keeping subjects, sites, and monitors safe while deciding whether and how to continue clinical trials or if they should be placed on hold. Considering the input from the stakeholders and the recent Food and Drug Administration (FDA) and European Medicines Agency (EMA) guidance, CTTI compiled best practices for the conduct of clinical trials during the crisis.

Key best practices are:

  1. Continuing risk assessments throughout the crisis

  2. Transitioning to remote monitoring and remote study visits (telehealth) when the risk assessment supports continuing trials

  3. Pausing enrollment if feasible

  4. Communicating with IRBs

  5. Documenting the COVID-19 restrictions changes

  6. Informing subjects

The key factor in decision making is keeping the subjects safe based upon a risk assessment. Safety is the primary goal in determining the best way to proceed with each trial. There needs to be flexibility as each situation may be different.

- The Clinical Pathways Team

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