With social distancing, borders closing, people self-quarantining at home, traveler screenings at airports, and people just trying to get home from abroad, perhaps only those contemplating starting or having an ongoing clinical study are thinking about or asking for guidance about what to do with clinical studies, while many of us are simply worried about finding a store that has toilet paper in stock.  The fact is that the COVID-19 pandemic could have a major impact on the conduct of clinical studies.

Because of the significance of this issue from a scientific and public health perspective, the FDA has taken the immediate step of issuing a final guidance entitled FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards without first seeking public comment.  The FDA notes that because of the public health emergency, “this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)).  This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices.”

The document addresses the following issues:

Considerations for ongoing trials

Safety of the patients is obviously paramount, and the FDA recognizes that modification to the study protocols, including how required study visits can be arranged and what to do for patients that cannot get to the site to obtain study drug and no longer have access to the products is very important.  The FDA emphasizes that close contact with the IRB to assist in making appropriate safety decisions about patient welfare is required.

It also discusses making tough decisions.  “[F]or example, this assessment could include consideration of whether it is appropriate to delay some assessments for ongoing trials, or, if the study cannot be properly conducted under the existing protocol, whether to stop ongoing recruitment, or even withdraw trial participants.”

The Agency notes that mandated COVID-19 screening does not have to be reported in an amendment to the protocol unless the sponsor is incorporating the data into a new research objective under the study.  The FDA also gives further advice relative to other aspects of conducting and/or monitoring clinical studies while the pandemic continues.

In general, and if policies and procedures are not already in place for applicable trials

This section describes some of the actions sponsors should take if the protocol does not already have such policies and procedures in place, and the issues sponsors should consider.

For all trials that are impacted by the COVID-19 pandemic

This section addresses contingency measures, how to address patients affected by COVID-19 during the study, as well as suggestions as to how to address analysis of the impact of these patients on study results.

The FDA has taken an important first step, in a very short period of time, to address these important considerations to both protect patient safety and hopefully maintain the integrity of clinical studies that are impacted by this public health emergency.  The full guidance can be found here.