The FDA this month released guidance surrounding the conduct of clinical trials involving medical products during the COVID-19 pandemic.
The key themes of the guidance are (i) protect the health and safety of trial staff and participants; (ii) document all deviations; and (iii) consider implementing new or amending existing policies and procedures for clinical trial conduct to create uniform guidance for the conduct of trials during the pandemic.
In the realm of protecting the health and safety of trial staff and participants, the following suggestions, among others, are made that the sponsor and trial staff consider:
- Whether trial recruitment should continue with the recruitment of new trial subjects;
- Whether existing trial subjects should continue use of the investigational product;
- Which trial activities could occur remotely or in a non-healthcare setting;
- If trial activities typically include travel of the trial participants for testing or follow up visits, whether those can happen at local medical facilities and labs not requiring travel;
- Keeping trial subjects continuously informed of any changes made to the trial that affect them;
- Whether any processes need to be put in place for trial subjects who may be harmed by inaccessibility of the investigational product;
- Whether an investigational product usually distributed in a clinical setting could be distributed in an alternate manner;
- Whether it is appropriate to delay some assessments; and
- If planned on-site monitoring is not possible, whether central and remote monitoring may be acceptable alternatives.
Emergency amendments to the protocol for the safety of subjects is permitted, preferably with the guidance of the institutional review board (“IRB”), prior to receiving IRB approval (and FDA approval if required) for the amendments, although subsequent notification to the IRB and FDA are required.
Where any deviations from the protocol occur or COVID-19 changes affect the resulting data, those deviations should be documented. For example, the FDA indicates that the clinical study report should contain the following information:
- Contingency measures implemented to manage disruption of study conduct as a result of COVID-19 measures;
- A listing of subjects impacted by the COVID-19 study disruption including the subject’s study specific ID number, site, and a description of how that individual’s participation was altered and;
- Analysis and explanation of how the COVID-19 measures ultimately affected the safety and efficacy results reported.
In the implementation of policies and procedures addressing trial conduct during the COVID-19 pandemic, sites and sponsors should consider:
- Impact on the informed consent process;
- Study visits and procedures;
- Data collection;
- Study monitoring;
- Adverse event reporting; and
- Changes to investigator(s), site staff and/or monitor(s) secondary to travel restrictions, quarantine measures, or COVID-19 illness itself.
The guidance at its essence is an attempt to balance protecting the health and safety of individuals involved in the conduct of clinical trials with the maintenance of the academic integrity of the results of studies taking place during the pandemic.
For the full text of the guidance, please see https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-pandemic.