Are There Specific Criteria Used to Determine Whether Patients Can Receive an Investigational Drug Outside the Clinical Trial Setting?
To be considered a candidate for receiving an investigational drug outside of a clinical trial drug investigation setting, patients usually must:
- Have already tried the standard treatments available on the market without experiencing success
- Be unable to participate in any ongoing clinical trials for drugs appropriate for their cancer diagnosis
- Have a cancer diagnosis for which an investigational drug product has already demonstrated an acceptable level of safety and efficacy. Said product must be currently studied in either a Phase 2 or a Phase 3 clinical trial drug investigation.
Importantly, the potential risks involved with using an investigational drug must not outweigh the potential benefits on either the patient’s quality of life or survival rate.
FDA Regulations Concerning Patient Access to Investigational Drugs
Under the Federal Food, Drug and Cosmetic Act, a patient is eligible to pursue an investigational drug for the diagnosis, monitoring or treatment of their cancer diagnosis as long as long as:
- Both the patient and doctor are both willing to participate in the process of expanded access
- The physician determines there is no drug product currently on the market that can address the patient’s condition in the same way that the investigational drug product may be able to
- FDA determines and has gathered enough evidence to suggest the investigational drug meets the requisite safety and efficacy requirements to treat the patient
- FDA determines that any possible risks associated with the investigational product do not outweigh any benefits the patient would experience from taking one of the market’s standard therapies
- FDA determines that expanded access to the investigational drug will not in any way interfere with the ongoing clinical investigations and potential market approval
- The drug sponsor company submits a clinical protocol for the patient that the FDA determines meets agency standards for participation
- The patient is not able to participate in any of the ongoing clinical trials
TD2, a world-class drug development service specializing in getting the most innovative and best oncology treatments to patients in need, can help physicians fill out applications for patients to access investigational drugs. We can also provide information about regulatory must-knows.