FDA Guidance for Industry, Investigators and Investigational Review Boards on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

FDA Guidance for Industry, Investigators and Investigational Review Boards on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic

Updated on March 27, 2020

https://www.fda.gov/media/136238/download

This is an important guidance issued to address how the current COVID-19 pandemic may impact the conduct of clinical trials of medical products. Multiple challenges associated with the COVID-19 pandemic response, such as quarantines, research site closures, lack of  site personnel, supply chain disruptions, etc. are occurring or are anticipated for many clinical trials. Therefore, the FDA outlines general considerations to assist sponsors, investigators, research sites and others involved in clinical trials to ensure patient safety, maintain Good Clinical Practice compliance and to minimize risks to trial integrity. The updated version also includes a series of questions and answers.

During this challenging time, the FDA guidance discusses the essential need to ensure patient safety by considering whether to continue patient recruitment, continued patient use of investigational products or adaptation of how investigation product is delivered (e.g. modification from in-clinical to at-home infusions) to presently enrolled patients and needs to adapt or modify patient monitoring while keeping patients informed of any changes. Sponsors should determine if in-person study visits can be modified or changed, such as transition to virtual visits, finding alternative locations for trial assessments, etc. as well as if there is a need for addition safety monitoring for trial participants who no longer have access to investigational product.

Any expected or urgent changes or modifications to existing clinical study protocols should be addressed as soon as possible to reduce or eliminate potential risks to study participants. FDA encourages sponsors and investigators to engage their local Investigational Review Board  as early as possible to discuss necessary changes to study conduct and how these changes could impact study participants safety. The guidance also outlines unique approaches to obtain patient informed consent in situations where COVID-19 infection control restrictions are in place. These include electronic informed consent, video or phone calls with a witness and photographed consent forms for documentation (when the consent form cannot be collected from the patient’s room or isolation).

As early as possible, sponsors should communicate to the FDA any clinical trial changes that may impact efficacy assessments, such as delays in assessments and alternative data collection methods. Specific changes that impact the trial design and statistical elements of a study should be made in consultation with the appropriate review division at FDA. For trials conducted under an Investigational New Drug (IND) the guidance advises sponsors to submit a formal protocol amendment with a tracked changes version to the IND and to include a cover letter that includes COVID-19 in the subject line and a summary of the major protocol changes.

For clinical trial reporting, sponsors are encouraged to describe contingency measures that were implemented, a listing of all study participants affected by any COVID-19 related trial disruptions and analyses of how these disruptions affected the safety and efficacy results. Prior to database lock, the trial statistical analysis plan should be updated to address how protocol deviations or changes associated with COVID-19 will be handled in pre-specified analyses.