The Physician’s Role
The treating physician is the link between desperately ill patients and three key players in the expanded access process: the drug manufacturer, the Food and Drug Administration (FDA), and the institutional review board (IRB). Once approval is obtained, the physician also administers the experimental medicine and monitors the patient’s response.
Because many physicians are not familiar with the process, WCGF has summed it up below. A PDF version of the information can be downloaded here.
Responsibilities of a Sponsor-Investigator (Treating Physician):
- Apply to and obtain approval from FDA and an IRB prior to administering the investigational product.
- Seek IRB approval for continuing review if the treatment use extends longer than one year or a second dose is needed.
- Obtain and document appropriate informed consent from the patient or legally authorized representative prior to treatment.
- Maintain accurate case history records and observations related to provision of product, including adverse events.
- Report adverse events as required by FDA.
- Maintain accurate documentation of the disposition of investigational product, including dates, quantity, and use.
- Adhere to reporting obligations of IRB, FDA, and sponsor.
- Prepare and send summary report of treatment use to sponsor and FDA.
- Maintain confidentiality of the information both about the patient and the condition.
- Comply with applicable local laws and institutional policies.