When reviewing single patient expanded access requests, IRBs face four challenges:
- To speed up the review process for patients who truly are almost out of time.
- To ensure that the investigational product will not cause undue harm to the patients involved.
- To ensure that patients make informed decisions about using the investigational product.
- To avoid jeopardizing marketing approval process for the investigational product.
Clinical Research Pathways has identified the following four-step process to support IRBs and desperately ill patients. A PDF version can be downloaded here.
Streamlining Procedures for Single Patient Expanded Access Requests
- FDA Form 3926 when the treatment use involves an investigational drug or biologic or a treatment plan for investigational medical devices that includes the same type of information required in the FDA Form 3926.
- Investigator brochure or another source describing risks and potential benefits of the treatment.
- Draft consent document.
- As of October 3, 2017, FDA permits the IRB chair or designee to review and concur with the expanded access request involving an investigational drug or biologic.
- FDA guidance permits the IRB chair to review and concur with an expanded access/compassionate use request involving an investigational medical device. Note: FDA guidance does not permit a designee to conduct the review.
- Confirm the medical evaluation of the patient’s condition based on the information provided by the treating physician. This individual must be able to confirm or deny the claim that there is no comparable or satisfactory alternative available.
- Ensure that informed consent or appropriate permissions will be obtained and documented. Given the compassionate nature of the request and FDA’s involvement, consent documents should meet the requirements listed in 21 CFR 50.25, using plain language that is specifically aimed at “patients” who expect direct benefit, as opposed to “subjects” who may not expect benefit.
- Receive documentation that FDA has made its determinations regarding safety and effectiveness and has given clearance for the use. Request the IND or IDE number and any documentation from FDA.
- Review the physician’s treatment plan (or sponsor-provided treatment protocol) and determine that it makes adequate provision for ensuring the safety of the patient including adequate monitoring (timing and type of tests/exams, etc.) and appropriate plans for collecting and reporting the data.
Assistance with IRB Procedures
We encourage all IRBs to streamline the review process so that every patient request for expanded access is approved quickly. For more information, including assistance with your IRB procedures, please contact Clinical Research Pathways at email@example.com or call 404.386.8982. Together, we can make a difficult time a little easier for desperately ill patients and their families.
From Clinical Research Pathways
- Intermediate-size Patient Population Expanded Access Use
- Responsibilities of a Sponsor-Investigator (Treating Physician)
- How to Request Treatment Use via FDA’s Expanded Access Process (Non-Emergency)
- Points for Patients to Consider, PDF version, printed brochure, printing instructions
- The Right-to-Try Pathway
- Streamlining IRB Procedures
- FDA Guidance: Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers (October 2017)
- FDA Guidance on IDE Policies and Procedures, (January 20, 1998)
- FDA website
- FDA Form 3926 *Right-click and select “save link” to save the file to your computer)
- For drug-related expanded access: FDA Division of Drug Information, 301-796-3400 or firstname.lastname@example.org
- For biologics-related expanded access: FDA Biologics Office of Communication, Outreach, and Development, 800-835-4709 or email@example.com
- For medical device-related expanded access: FDA Device Division of Industry and Consumer Education, 301-796-7100 or DICE@fda.hhs.gov