The FDA has issued guidance for IRB review of individual patient expanded access requests, as well as updated guidance for managing clinical trials during the COVID-19 public health emergency.
Originally issued in March, the FDA’s updated “Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency” provides recommendations for addressing challenges with clinical trials due to site closures and restrictions, supply chain interruptions and quarantines. It provides considerations along with multiple Q&As for:
- Conducting required protocol visits via alternative methods (phone, telehealth, alternative locations);
- Conducting additional safety monitoring as necessary;
- Implementing COVID-19 screening procedures without amending the protocol, and other protocol deviations without the need for amendment, such as for emergencies;
- Increasing documentation of the impact COVID-19 may have on a trial subject’s participation or other protocol-specific procedures;
- Procedures for alternate arrangements for shipment and administration of investigational products;
- Central/remote monitoring and outcome assessment procedures; and
- Obtaining informed consent from patients in isolation or who are unable to travel.
The FDA also issued guidance in response to an increased volume of requests for access to COVID-19 investigational drugs through the “IRB Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency”. The FDA currently permits “compassionate use” of investigational products for patients with serious or life-threatening conditions where it meets specific requirements. However, the guidance provides clarifications and recommendations to IRBs and clinical investigators specifically when reviewing individual requests for access to COVID-19 products, including emergency use. The guidance only addresses requests involving single patients, and not intermediate or larger size populations.
Emergency patient access requests do not require prior IRB review, as long as the IRB is notified within five working days from treatment. For non-emergency patient access requests, waivers are permitted from full IRB review if the requesting physician has obtained concurrence from the IRB chairperson or other IRB member prior to beginning treatment. The FDA additionally recommends IRBs:
- Establish procedures for a single IRB member to review requests where a waiver is sought, including documentation of whether the IRB member concurs or does not concur with the treatment;
- Focus review on the risks and benefits to the patient, including “whether risks to the patient have been minimized…and are reasonable in relation to anticipated benefits.” The expectation is that the IRB review the known risks of the drug, the patient’s history and treatment plan, including proposed dose, route and frequency of administration, duration, criteria for discontinuation of treatment, monitoring for adverse events and response to treatment, and other key details of the patient’s history and clinical condition.
- Review the physician’s qualifications and appropriate consent procedures, including assent/guardian consent for individuals who are minors.
Both guidance documents will remain in effect for the duration of the COVID-19 public health emergency, with any necessary changes implemented by the FDA after the cessation of the public health emergency. Additional resources, FAQs, updates and general information from the FDA concerning the COVID-19 public health emergency can be reviewed on the FDA’s COVID-19 website.
