COVID-19 is having a profound effect on clinical trials for medical products, including drugs, devices and biological products. Site closures, travel restrictions, quarantines, infections among participants and trial personnel, and investigational product supply chain issues are just a few of the concerns facing sponsors that may impact protocol-specified procedures.
On March 18, 2020 the Food and Drug Administration (“FDA”) issued (and updated on April 2, 2020) a Guidance entitled Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic (the “Guidance”). The Guidance is effective immediately and will remain in effect for the duration of the COVID-19 pandemic. The Guidance is intended to assist industry, investigators and Institutional Review Boards (IRBs) with navigating and assessing how to move forward with clinical trials while ensuing compliance with good clinical practice (GCP). FDA provides sponsors with detailed considerations for issues including study modification, documenting the basis for missing data, and alternative investigational product accountability and delivery methods, including the need to alter patient monitoring. The Guidance also provides recommendations for switching patients to home infusion, handling home delivery of investigational products and obtaining informed consent. The Guidance includes factors to weigh when deciding to suspend, continue or initiate new studies at this time.
Policies and Procedures will need to be created or updated to address the possible disruption to the clinical trial from COVID-19. For all trials, certain changes such as virtual visits or phone contact and alternative assessment locations, may be made without IRB approval. However, protocol or informed consent changes and/or amendments or supplements to the Investigational New Drug (IND) Application or Investigational Device Exemption (IDE) require that IRBs be engaged as early as possible.
On March 27, 2020, the Guidance was updated to include Questions and Answers FDA has received from sponsors which it is currently maintaining in a tracking system. FDA has vowed to provide regulatory flexibility and will most likely rely on virtual inspections and audits for study assessments. Sponsors should prepare for them just as they would for on-site inspections.
The Guidance was implemented without prior public comment due to the emergency nature of the COVID-19 pandemic. However, it remains subject to public comment and interested parties may submit comments to FDA.
Additional resources may be found on the FDA website at the following addresses: CDER, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs; CBER https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/contacts-center-biologics-evaluation-research-cber#indcont; CDRH https://www.fda.gov/about-fda/cdrh-offices/cdrh-management-directory-organization.
How Frier Levitt Can Help
Frier Levitt has a cadre of experienced FDA attorneys and former in-house counsels in the pharmaceutical industry. During the COVID-19 pandemic we can provide counsel to sponsors and CROs in areas such as, conduct of trials, revisions to existing policies and protocols, use of telehealth in clinical trials, protection of human subjects and preparation of comments to the FDA. Contact us today to speak to one of our attorneys.
