The US Food and Drug Administration (FDA) has released guidance, which provides clarification for institutional review boards (IRB) and clinical trial investigators, when reviewing individual patient expanded access requests related to COVID-19.
Sometimes called compassionate use, expanded access is a potential pathway for a patient with an immediately life-threatening or serious disease, to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials, when no comparable or satisfactory alternative therapy options are available.
In response to the increase in expanded access requests due to the pandemic, the guidance recommends that IRBs should consider establishing a mechanism for individual members to review expanded access requests for investigational drugs and biologic products to treat COVID-19. This guidance applies to expanded access requests on behalf of individual patients only.
During this public health crisis, individual reviews should focus on the risks and benefits of the investigational treatment for the individual patient. The IRB must obtain sufficient information to ensure that the benefits outweigh the risks to the patient, and that the risks have been minimised. The IRB should be provided with a summary of the known risks of the proposed investigational drug.
The guidance suggests that having a thorough patient history and treatment plan can be enough information for an IRB to make an assessment in an individual patient’s case. The treatment plan should include details of how the investigational drug will be administered, including criteria for discontinuation of treatment and how dosing will be modified in the case of adverse events. The plan should also outline how the patient will be monitored for adverse events, clinical status, and treatment response.
The IRB should consider the qualifications of the physician submitting the request. Informed consent should meet FDA requirements, making clear to the patient or representative that although the drug is being used for treatment, it is under investigation and therefore its use involves research.
When completing FDA Form 3926 to request individual patient expanded access for COVID-19, physicians can request a waiver from full IRB review, paving the way for single-member IRB review.
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