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 request approval from the FDA to treat the patient through submission of an individual patient IND. These requests must also be approved 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 for the preparation and submission of regulatory applications, including IND and IRB requests. Regulatory work will be performed by a select group of experienced staff with extensive training and education in the regulatory field. The Office of Regulatory Affairs and Quality (ORAQ) will assist with obtaining approval from the drug company and submitting the IND, while a core of regulatory coordinators will process the IRB application. As a means to organize and expedite the workflow, the requesting physician will be informed of progress via email notifications. 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 or DOCRfirstname.lastname@example.org.
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