To support Duke physicians interested in obtaining expanded access to investigational drugs, Duke University Hospital (DUH) and Duke University School of Medicine (SOM) have teamed up to provide a no-cost resource that assists physicians with the process, including institutional and regulatory approval processes. The services provided for expanded access requests are described in detail below. If you are interested in using the service, please complete the survey which best aligns with your request.
To treat a single patient with an investigational drug, please complete the following survey:
To treat multiple patients with an investigational drug under an existing expanded access program (EAP) or to initiate an intermediate-sized EAP for your investigational drug, please complete the following survey:
Expanded Access Request Service
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, or a small group of patients, 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 also be granted by the FDA, 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, Duke University Hospital (DUH) and Duke University School of Medicine (SOM) have teamed up to provide a no-cost resource that assists physicians throughout the entire process, including support in each of the following areas:
- Pharmacy and Therapeutics Committee Approval: Duke University Hospital Pharmacy and Therapeutics (P&T) Committee will review all requests for expanded access and grant approval for utilization of non-FDA approved medications per institutional requirements.
- Drug Company Approval: Dedicated staff will assist with obtaining approval from the drug company and will work with the Office of Research Contracts (ORC) to ensure proper contractual and confidential disclosure agreements are in place for the expanded access use.
- FDA Authorization: When required, ORAQ will prepare and submit an investigational new drug (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 or full board approval 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 Drug Service (IDS) Pharmacy.
- MaestroCare Order: An analyst will build an order in MaestroCare so the drug can be ordered and documented in the patient’s medical record.
- Expanded access reporting (intermediate-sized programs only): A core of research coordinators will assist with reporting obligations to the drug manufacturer by completing case report forms and preparing and submitting adverse event reports, as applicable.
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 request process. If approved by the P&T Committee, all individual patient expanded access requests will be supported by this resource, including both emergency and non-emergency use situations. Intermediate-size program requests will be evaluated for support by the service based on program funding, and programs will either be supported by the service or recommended for execution in the Clinical Research Unit (CRU).
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.
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
Pharmacy and Therapeutics Committee: 919-684-5125
TEAMSS (Transforming Expanded Access to Maximize Support and Study) seeks to advance clinical care and translational research by improving patient access to experimental therapies. This federated, national consortium for Expanded Access interventions is a partnership led by the University of Michigan with Duke University, University of Rochester and University of Texas Southwestern. Expanded Access provides an opportunity for patients who either lack therapeutic options or who are ineligible for clinical trials to potentially benefit from the clinical use of experimental drugs, biologics, and medical devices. By developing this national consortium, we will build a positive impact by, for the first time, creating a foundation for an integrated, nationwide approach to Expanded Access that can improve care for the most vulnerable patients.