USA: FDA updates its guidance on the conduct of clinical trials of medical products during COVID-19 emergency
The US Food and Drug Administration (FDA) updates its guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.
The Agency added information about electronic signatures for informed consent and provided clarification about remote assessments during clinical trials.
The FDA recognizes that the coronavirus public health emergency may impact the conduct of clinical trials of medical products, including drugs, devices, and biological products. Challenges may arise from isolation practices, site closures, travel limitations, interruptions to the supply chain for the investigational product, or when site personnel or study subjects become infected. These challenges may lead to difficulties in conducting the clinical trials.
In addition, the guidance further expands on an existing question-and-answer about remote clinical outcomes assessments (COAs) to include four types of COAs: performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes.
The FDA is aware that protocol modifications may be required, and that there may be unavoidable protocol deviations due to COVID-19.
The guidance outlines general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice, and minimizing risks to trial integrity.
For more information, please see the guidance and a press release from FDA.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
