Earlier this week, the FDA issued a guidance on the conduct of clinical trials during the ongoing Coronavirus Disease 2019 (COVID-19) pandemic. “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 an accompanying 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 with regard to 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 (IRB) 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 that already are in place and 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.
- 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, 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, then 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 seek out a dialogue with the appropriate FDA division to consult them in regards to the potential impact of COVID-19 on a particular clinical trial.
As this situation evolves, RPI, A Division of Premier Research, is dedicated to keeping you informed. Keep checking this blog for new information and updates.