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FDA Issues Guidance on Clinical Trials During COVID-19

In March 2020, at the start of the COVID-19 pandemic, the FDA issued guidance on the conduct of clinical trials. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,” said Anand Shah, M.D., FDA Deputy Commissioner for Medical and Scientific Affairs, in a statement. “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.”

In line with the challenges created by the COVID-19 pandemic, the FDA provided some recommendations regarding the conduct, monitoring, and data aspects of ongoing and future clinical trials. We’ve listed some of the key considerations for sponsors below. For more information, consult your project manager or contact Premier Research’s COVID-19 Task Force.

What sponsors need to know

  • Certain changes can be made without institutional review board approval. For example, virtual visits, phone contact, or alternate assessment locations — such as local labs or imaging centers — may be arranged and “may be sufficient to assure the safety of trial participants,” according to the guidance. In cases where patient safety is further enhanced, an IRB submission/approval may not be needed
  • Using centralized monitoring tools already in place that don’t require additional analytical tools is one way to depart from current monitoring practice
  • If trial participants no longer have access to the investigational product or site, they may need additional safety monitoring to assess any effects related to the withdrawal of the investigational treatment
  • It’s important to clearly document how restrictions related to the pandemic led to changes in the study, the duration of those changes, whether or how study participants were affected, and which individual patients were affected (e.g., changes to study visit windows, patient discontinuations, missing data, or changes, or deletion of endpoints)
  • Prior to database lock, sponsors need to address protocol deviations, dropouts, and the relevant statistical impact on study results. If a statistical analysis plan needs to be amended, those actions need to be discussed with the FDA. New studies should account for COVID-19 impacts ahead of initiating clinical trials

Overall, it is recommended that sponsors contact the appropriate FDA division regarding the potential impact of COVID-19 on a particular clinical trial.

Premier Consulting has a long history of helping sponsors plan for and navigate virtually any regulatory requirement to attain commercial success. Contact us to find out how we can support your program.

Author:

Nach Davé
Vice President, Development Strategy

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