It is the true hybrid of clinical research and clinical care. A way of providing treatment-use or preventative-use access to groups of people in the target population who cannot participate in clinical trials, Expanded Access is important for doctors and patients who have the greatest unmet needs. Expanded Access Programs (EAPs) can also generate valuable clinical data and is becoming a standard part of the clinical development process for new medicines in some therapeutic areas.
But what happened in 2020? Why aren’t we hearing more about Expanded Access for new COVID-19 therapeutics and vaccines?
Unfortunately, pre-market access to medicines remains poorly understood among life-science and healthcare professionals, overall. An increasingly politicized discussion around Emergency Use Authorizations has, for many people, gotten in the way of learning how Expanded Access programs also enroll large numbers of patients outside the traditional trial enterprise, but does so with a defined protocol, informed consent, and centrally monitored data collection. An Expanded Access Program is a clinical trial for “treatment-use” and is different from an Emergency Use Authorization.
When the 2020 pandemic began spreading outside China, we predicted more and more people would seek a central source of definitive information about Expanded Access. We were right, and it’s happening now.
Ax-S Pharma, which produces the annual Expanded Access Summit ® has worked through the Summer to build a definitive online resource for this topic. Its programs comprise over ten years of policy initiatives, workshops, and leadership forums. The new online hub combines that with free access to selected videos and publications.
This year, we have grown our world class faculty – representing FDA, NIH, BARDA, and ASCO, as well leading life science and healthcare organizations- for an upcoming LiveCast series on the integration of clinical research into modern healthcare delivery. This series will cover the most relevant innovations in Expanded Access, but also tie in drug repurposing, master protocol & platform trials, passive EHR capture, and trial site decentralization. Registration is free for the first thousand registrants, and a Premium Pass -unlocking all sessions and premium content- can be purchased for under $50.