When a patient has a serious or immediately life-threatening condition that is not addressed by currently approved therapies, a physician may wish to offer an investigational drug (i.e., one that has not been approved by FDA) to treat the patient. While investigational drug use is usually limited to clinical trials where an investigational new drug (IND) application allows the product to be administered to human subjects, there are circumstances where a physician may be granted permission to use an investigational drug under expanded access.
Expanded access is the use of an investigational drug outside of a clinical trial to diagnose, monitor, or treat patients with serious or immediately life-threatening diseases or conditions for which there are no acceptable alternative therapies. Physicians that have identified a patient who may benefit from an investigational drug must first seek approval from the drug company that manufacturers the drug. If the company agrees to provide the drug, authorization must then be requested from the FDA through submission of an individual patient IND. These requests must also be authorized by an Institutional Review Board (IRB) and be conducted in compliance with FDA regulations on informed consent.
To support Duke physicians interested in obtaining expanded access to investigational drugs for individual patients, Duke University Health System (DUHS) and Duke University School of Medicine (SOM) have teamed up to provide a resource that assists physicians throughout the entire process, including support in each of the following areas:
- Drug Company Approval: The Office of Regulatory Affairs and Quality (ORAQ) will assist with obtaining approval from the drug company for the expanded access use. ORAQ will also work with the Duke Office of Research Contracts (ORC) to ensure proper contractual and confidential disclosure agreements are in place for the expanded access use.
- FDA Authorization: ORAQ will prepare and submit the individual patient IND application to the FDA and will assist with maintaining that application once the investigational use has been authorized.
- IRB Authorization: A core of regulatory coordinators will assist with drafting an informed consent document and will process the IRB application through iRIS to receive IRB Chair Concurrence for the expanded access use.
- Investigational Drug Service: The investigational drug product will be received, stored and prepared for administration (as applicable) by Duke’s Investigational Pharmacy.
- MaestroCare Order: An analyst will build an order in MaestroCare so the drug can be ordered and documented in the patient medical record.
As a means to organize and expedite the workflow, the requesting physician will be informed of progress via email notifications at each step of the process. All individual patient expanded access requests will be supported by this resource, including both emergency and non-emergency use situations.
Interested in utilizing this resource? Please complete the survey of required information, and key team members and staff will be notified of your request. For questions or additional information, please contact ORAQ@duke.edu.
Ordering Investigational Drugs in Maestro Care
To place an order for a drug being administered under an individual patient IND in Maestro Care, please use the following instructions:
Key Contact Information
Duke Office of Clinical Research: 919-681-4680
Institutional Review Board: 919-668-5111
Investigational Drug Service: 919-684-3543
Maestro Care Analysts: 919-613-5740
Office of Regulatory Affairs and Quality: 919-668-4639
Office of Research Contracts: 919-681-6483