In circumstances where participation in a clinical trial is not feasible and the patient has exhausted all available treatment options, regulatory authorities may grant permission for a treating physician to provide an investigational drug before formal approval. This provision for individual access to an investigational drug is commonly referred to as “single patient expanded access” or “compassionate use,” although other designations may also be known by it.
All individual requests must be submitted by a treating physician and should include the following information to be considered:
- Date of request
- Requesting physician’s name, contact information, address (including country), and professional designation (i.e., MD) or qualifications
- Name of the requested investigational medicinal product along with physician’s intended treatment plan, including therapeutic indication and expected duration of treatment
- Medical rationale for request including an explanation for why alternative therapy cannot be used, why the patient does not qualify for a clinical trial, and why use of the investigational drug is in the patient’s best interest
- Relevant medical patient information (medical history, current condition, demographics)
Please submit request to: expandedaccess@iteriontx.com
