Decentralized, Virtual, and Hybrid Clinical Trials
Live Panel Session
Thursday, Mar 11, 2021 | 12:00pm – 1:30pm Eastern
Thursday, Mar 11, 2021
Clinical Innovation Partners
Jen Horonjeff, PhD
CEO, Savvy Cooperative
Michelle Longmire, MD
Bristol Myers Squibb
Ax-S Pharma is the leading education resource on Expanded Access to new medicines, worldwide.
February - March 2021
Our series of 4 panel-session webcasts, accredited education videos, group discussions, and additional multi-media resources together in a single virtual conference environment, throughout February and March.
Register now to gain 24/7 access to all programming, video-networking, and exhibits.
5 Core Topics
Ax-S Pharma brings together world leaders from industry, medicine, and policy centers to provide members an unparalleled range of information and perspective on the integration of research and healthcare.
Our programming includes accredited material for Continuing Education
Become a member to gain access to Videos and Publications in addition to Special Event Invitations and our Newsletter
Expanded Access Explained
Global and Large Scale
Most countries allow “treatment-use” of new pre-market medicines for serious unsolved health conditions. Since 1987, Expanded Access Programs in the U.S. have been used to treat more than 250,000 patients in a range of serious diseases.
In Harmony with Ongoing Research
EAPs have been used widely to enroll large numbers of on-label patients who are outside the inclusion/exclusion criteria of a product’s research trials. Properly designed Expanded Access trials or “Expanded Access programs” (EAPs) have also helped to recruit and retain eligible patients in research trials, and in many cases generated structured data that sped the development and market approval of the particular product. Despite widespread misconception, we have found no evidence of an authorized EAP impeding the enrollment of any research study or negatively impacting clinical development of the particular product.
Bringing Inclusivity to Clinical Development
Expanded Access regulations require that treatment is the primary objective in these programs and therefore grant EAP sponsors privileges that would not be appropriate for research trials. Compared to the cost of clinical research, the per-patient cost of Expanded Access can be very low. To learn more about the regulation, history, or best practice of Expanded Access in any country, contact us here.