The US Food and Drug Administration (FDA) has issued a guidance for industry, investigators, and institutional review boards in regard to how to conduct clinical trials during the current coronavirus (COVID-19) pandemic.

The FDA recognizes that the current pandemic will lead to numerous challenges (site closures, quarantines, interruption in supplies, etc.) to strictly adhere to current protocols for specific clinical trials. To that end, some trials will likely stop while others may be amended. However, at the core of each clinical trial decision must be the safety of the patient.

In a news release,  Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA, said, “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations. We want to support the continuance of these clinical trials in compliance with good clinical practice and minimizing risks to trial integrity, while also safeguarding the health and well-being of study participants.”

Some of the considerations being recommended by the FDA include:

Safety

  • The FDA recommends that 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.
  • In some cases, trial participants may require additional safety monitoring.

 

Efficacy

  • FDA recommends consulting with the appropriate review division regarding protocol modifications for the collection of efficacy endpoints, such as use of virtual assessments, delays in assessments, and alternative collection of research-specific specimens, if feasible.
  • For individual instances where efficacy endpoints are not collected, the reasons for failing to obtain the efficacy assessment should be documented (e.g., identifying the specific limitation imposed by COVID-19 leading to the inability to perform the protocol-specified assessment).
  • If changes in the protocol will lead to amending data management and/or statistical analysis plans, the sponsor should consider doing so in consultation with the applicable

 

Logistics

  • Sponsors, in consultation with clinical investigators and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), may determine that the protection of a patient in the trial may be to continue the trial, stop the trial, or postpone the trial.
  • The FDA states that such decisions will depend on specific circumstances, including the nature of the investigational product, the ability to conduct appropriate safety monitoring, the potential impact on the investigational product supply chain, and the nature of the disease under study in the trial.
  • In all cases, existing regulatory requirements for maintaining investigational product accountability remain and should be addressed and documented; however, if scheduled visits will be significantly impacted, alternative secure delivery methods may be explored.

 

Location

  • Since trial participants may be unable to come to investigational sites due to protocol-specified visits, sponsors should assess whether alternative methods for safety evaluations could be implemented when necessary and feasible.
  • Additionally, in deciding to continue or discontinue use or administration of the investigational product, sponsors should consider whether the safety of participants can be ensured by implementing the alternative approach.

 

COVID-19

  • Screening procedures that may be mandated by site in which a clinical trial is being conducted. This data does not need to be reported within the trial protocol unless relevant.
  • Due to possible changes in study visit schedules, missing visits, or patient discontinuations, it will be imperative to capture specific information in the case report that details the basis of missing data, including the relationship to COVID-19.

 

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