Expanded Access Uses

Expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition 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. While the FDA refers to this as expanded access, these treatment programs may also be called an EAP, a treatment protocol, a single patient IND (SPIND), an emergency use, a compassionate use or a post-trial access program (PTAP).

As expanded access use and emergency use of an investigational agent is not considered research by the University of Kansas Medical Center or The University of Kansas Health System, health system support from a CRNC EAP Specialist will be available to assist with IRB review and the required regulatory processes that follow the same pathways of a clinical trial.

Please note that expanded access uses supported by the health system will utilize health system resources, such as physicians’ usual clinic and procedural spaces and usual clinic staff for visits and procedures. For this reason, physicians requesting support for expanded access uses should ensure their health system resources have the capacity for the use or program they are requesting.

Please email the physican's name, drug name, goal date of treatment and patient MRN (if applicable) either to oncology or non-oncology clinical research nurse coordinators if you have a patient you would like to treat via expanded access/compassionate use pathways.

Once complete, an EAP clinical research nurse coordinator will contact you to assist.

Emergency Use of Investigational Drugs or Devices

Some expanded access uses may require emergency approval from the IRB. Please confirm the patient meets the required criteria listed at the link below:

Emergency Use of Investigational Drugs or Devices

Please email the physican's name, drug name, goal date of treatment and patient MRN (if applicable) either to oncology or non-oncology clinical research nurse coordinators with the required information as soon as possible.

Expanded Access Use Criteria

In order for the FDA to permit expanded access to an investigational drug, the following criteria (found in 21 CFR 312.305(a)) must be met:

• The patient to be treated has a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor or treat the disease or condition;

• The potential patient benefit justifies the potential risks of the treatment use and those potential risks are not unreasonable in the context of the disease or condition to be treated; and

• Providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use or otherwise compromise the potential development of the expanded access use.

Start the Expanded Access Process

Please email the physican's name, drug name, goal date of treatment and patient MRN (if applicable) either to oncology or non-oncology clinical research nurse coordinators if you have a patient you would like to treat via expanded access/compassionate use/emergency use pathways.

Once complete, an EAP clinical research nurse coordinator will contact you to assist.

Health System Expanded Access Program Specialist Contacts

Oncology Clinical Research Nurse Coordinators

Non-Oncology Clinical Research Nurse Coordinators

Resources

• Support and Use of Drugs and Biologics Under the Expanded Access Program (internal access only)
• FDA Expanded Access Physician Resource Page
• KU Medical Center IRB Emergency Use
• KU Medical Center IRB Individual/Single Patient/Expanded Access Informed Consent Form Template
• FDA Code of Federal Regulations Related to Expanded Access
• Expanded Access - UT Southwestern
• Reagan-Udall Foundation Expanded Access Navigator Company Directory