Clinical Trial Protocols Set to Change During COVID-19 Pandemic

The COVID-19 pandemic is halting and slowing down clinical trials, and the Food and Drug Administration is offering guidelines to adjust to these new challenges.

Clinical trials may slow, stop or change during the COVID-19 pandemic, according to the Food and Drug Administration (FDA), which issued official guidance March 18 for industry, investigators and any institutions con- ducting trials that are facing challenges like quarantines, travel restrictions, site closures and even self-isolation of researchers or trial participants that contract the virus.

Trial investigators are encouraged to consider whether self-administered drugs can be securely delivered to participants at home, and whether treatments usually given by health care professionals can be administered alternatively; for instance, by home nurses or other trained personnel.

The guidance also calls for alternative methods of contacting participants, such as phone contacts or virtual visits, when possible or necessary, and extra safety monitoring for those who can no longer visit their trial site or get the investigational product and study-mandated tests they were previously taking.

Researchers will also need to con- sider whether delaying assessments, stopping recruitment or withdrawing participants will be necessary, and will be responsible for letting their review boards know about any changes, as well as for documenting any information that is missing due to the pandemic.

Finally, the FDA wants trial leaders to discuss with their review boards any

modifications to the way study results will be collected and to document the reasons for any data that cannot be gathered.

“Efforts to minimize impacts on trial integrity, and to document the reasons for protocol deviations, will be important,” the FDA wrote.