New FDA Guidance Provides Some Answers to Complex Trial Conduct Issues

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The U.S. Food and Drug Administration (FDA) has issued its latest guidance in a series designed to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with Good Clinical Practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The new guidance, dated August 2021, updates the previous guidance of the same title issued in January 2021.

In the new guidance, FDA provides answers to 28 questions received over the past several months from clinical trial practitioners struggling to adapt to conducting operations in a pandemic environment. Topics include when to suspend, continue, or initiate a trial; how to submit changes to Investigational New Drug and Investigational Device Exemption protocols; how to handle remote site monitoring visits; and how to manage shipping investigational products to local service providers and related accountability issues.

“Ensuring the safety of trial participants is paramount,” FDA says in the new guidance. “Sponsors should consider each circumstance, focusing on the potential impact on the safety of trial participants, and modify study conduct accordingly. Study decisions may include those regarding continuing trial recruitment, continuing use of the investigational product for patients already participating in the trial, and the need to change patient monitoring during the trial. In all cases, it is critical that trial participants are kept informed of changes to the study and monitoring plans that could impact them.”

Edited by Michael Causey