American Society of Clinical Oncology (ASCO) and the U.S. Food and Drug Administration (FDA) jointly announced the launch of a new set of online resources to help physicians fully understand requirements for Expanded Access to investigational therapies. These resources are now available to all physicians, free of charge, through ASCO?s physician education website, ASCO University
If there is scientific evidence to suggest that treatment with an unapproved therapy may be beneficial and the patient has exhausted all other treatment options and is not eligible for a clinical trial, the FDA-regulated Expanded Access pathways allow physicians access to an investigational agent for treatment purposes. ?The clinical trial system is a vital tool for testing promising new therapies, but many patients do not meet these often strict criteria.
The FDA?s updated Expanded Access program provide a chance for access to investigational agents for patients in need, but many physicians and patients are still unclear about the requirements for doing so,? said ASCO President-Elect, George W. Sledge, Jr., MD. ?We were pleased that FDA offered us the opportunity to help develop comprehensive educational materials to assist all doctors, and particularly oncologists, understand this process.?
?This collaboration will help doctors and their patients understand how to access investigational medications,? said FDA Principal Deputy Commissioner Joshua M. Sharfstein, MD. ?The Agency appreciates the opportunity to work with ASCO to develop these materials.?
FDA has allowed access to experimental drugs and biologics since the 1970s, if the manufacturer agrees first to provide the agent. However, the agency sought to clarify the rules when it issued updated regulations in August 2009, ?Expanded Access to Investigational Drugs for Treatment Use? and ?Charging for Investigational Drugs.?
To clarify the new rules for patients and the medical community, ASCO consulted the main stakeholders including representatives from patient advocacy groups, manufacturers, institutional review boards, FDA, as well as physicians, to develop a set of practical, interactive Expanded Access education resources to teach physicians how to work through the process as appropriate for their patient.
The resulting three online modules provide an introduction to the Expanded Access regulations, outline the process for requesting Expanded Access, and explain physicians? legal responsibilitiesfor treating patients with an investigational agent outside of a clinical trial. Included in the modules, are resources such as a glossary, an Expanded Access request checklist and helpful templates (letter to manufacturer, consent form, etc.) to ease the development of related paperwork. Although these tools were made with the oncology community in mind, these resources will also be helpful for doctors from other medical specialties.