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FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.
As the process for conducting conventional clinical trials becomes more difficult and more risky at a time when the public is advised to shelter at home and healthcare facilities become overwhelmed with caring for seriously ill patients, FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs. Strategies for ensuring the health of participants and site personnel are mapped out, along with processes for maintaining the integrity of the research program if it is altered or discontinued altogether. Several biotech firms recently announced the termination of clinical trials or decisions to delay launching planned studies, and more firms are expected to follow suite.
The new FDA guidance for drugs, biologics, and medical devices recognizes that the COVID-19 pandemic is disrupting research programs, as the risk of infection prevents site visits and testing of research participants. Research site closures, quarantines, travel limitations, and interruptions in clinical supplies may make it difficult for sponsors and investigators to enroll study participants, and patients may not be able to access study sites or to spend a day in a clinic for testing.
Such difficulties may require a sponsor to revise or reduce testing procedures, shift to online or remote monitoring, revise protocols, alter informed consent procedures, adopt new data collection practices, and to decide whether to continue a research program altogether. While the agency aims to help industry and investigators “assess how to move forward with critical clinical trials,” patient safety is a prime concern, stated Anand Shah, FDA deputy commissioner for medical and scientific affairs, in announcing the guidance this week. The advisory goes into effect immediately, omitting the usual period for comment and revision.
FDA hopes the guidance will help sponsors to address such developments quickly and efficiently, including strategies for modifying protocols, altering trial designs and regions of study, or delaying or cancelling ongoing studies. The National Institutes of Health (NIH) similarly issued guidelines for investigators conducting NIH-funded human studies to address patient safety issues and unanticipated costs and delays in research programs during the medical emergency.
The FDA guidance advises sponsors to fully document contingency measures implemented, all study participants affected by altered procedures, and the impact of participant discontinuation and alternative procedures for analyzing study results. Although sponsors can make necessary protocol changes immediately without approval of the agency or institutional review board (IRB), they should consult with appropriate FDA review divisions and IRBs as soon as possible regarding such actions, including the use of virtual assessments, delays in assessments, and alternative collection methods for specimens. And there should be clear documentation of how the pandemic has affected the use of the investigational product and the conduct of the trial.