Resources for Expanded Access
Clinical Research Pathways is committed to helping desperately ill patients who want the chance to try investigational medicines. These patients have exhausted all treatment options and are not able to participate in a clinical trial or wait for existing trials to be complete.
As a last resort, patients can turn to pharmaceutical companies and the Food and Drug Administration (FDA) for approval to participate in an expanded access (compassionate use) program. These programs allow patients to try investigational medicines provided patients receive permission from the drug sponsor, FDA, and an institutional review board (IRB). The process can be cumbersome and frustrating for patients and families who are all too aware that time is running out.
To help patients and to support the critical roles of IRBs and physicians, Clinical Research Pathways seeks to reduce the procedural obstacles that desperately ill patients can face. We serve as a resource to IRBs, providing information on FDA requirements, how to streamline the IRB review process for single patient expanded access, and what to consider when reviewing protocols for intermediate-size patient population expanded access. We also offer assistance to physicians who are applying for expanded access for their patients.