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:

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:

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.