Published on March 21, 2020

On March 18, the FDA issued a guidance document for the medical research industry as a result of the COVID-19 pandemic’s impact on research projects. The guidance contains nonbinding recommendations for sponsors, investigators, and institutional review boards (IRB) in conducting clinical trials of medical products. As nonbinding, these recommendations are not intended as requirements. Instead, the goal is to provide “continuity” in clinical trials during the pandemic. A short summary of this guidance document is provided below.

1. For patient safety 

  • Investigators should consider whether conducting the trial would have an effect on patient safety. Specifically, investigators should consider whether study enrollment should continue and whether an already enrolled patient should continue using the study product. Continuing enrollment and use of the study product is recommended only if it is in the patient’s best interests. 
  • Investigators should consider changing venues; this includes scheduling phone visits, virtual appointments, or alternate locations. In the event that there are changes in the study schedule or subjects are discontinued, the CRFs should capture “specific” details as well as the relationship to COVID-19.
  • Changes to the informed consent process may require eConsents with virtual appointments.

The above recommendations may impact the duration of clinical trials, either by closing out trials before endpoints are met or by extending the length of the trial in order to meet study endpoints. In addition, procedural changes with regard to the informed consent may require that sponsors and sites seek alternatives to “pen and paper” consent forms.

2. For onsite monitoring visits

  • Sponsors should consider moving toward a remote monitoring plan.

Moving to remote monitoring may result in a greater amount of users uploading source documents with protected health information. This allows monitors to perform source data verifications (SDVs) off-site. However, they should take measures to  ensure unauthorized access to these documents is prevented. In addition, it may be necessary to enable upload of large files to facilitate execution of a fully remote monitoring plan. The ability to reconcile investigational products off-site will be critical.

3. For clinical study reports

  • Analyses and discussions should address the impact of emergency measures on safety and efficacy results.

This alters statistical analysis plans which may deviate from original  protocols. As a result, this may provide an opportunity for conducting additional research.

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