National Landscape Assessment of Academic Medical Center Support for Expanded Access to Investigational Products

What is Expanded Access (EAP)? EAP to Treatment with the word intent under. Under the work Intent, Trial to Research. Aim is to Facilitate the availability of investigational new drugs to patients with serious diseases or conditions when there is no comparable or satisfactory alternative to therapy to diagnose, monitor, or treat the patient's condition
Image Credit
Virginia Kwitkowski, Partners in Progress, 8 Oct 2019

How often is Expanded Access used, and how often is support for it available? This is what the TEAMSS (Transforming Expanded Access to Maximize Support and Study) collaborative set out to determine through a survey of academic medical centers through the CTSA (Clinical and Translational Science Awards) network. Forty-seven sites responded, and the findings have now been published in the Journal of Clinical and Translational Research. 

The survey found that single-patient expanded access was widely used at over 90% of the sites that responded. Support for single-patient INDs was also commonly available. However, the level of support and who was providing it varied across institutions. Multiple-patient Expanded Access programs were less commonly available across the surveyed institutions. The support for these was both less common in general and rarely directed toward the specific requirements from sponsors. 

With the FDA and sponsors increasingly moving to multiple-patient programs as the preferred mechanism for Expanded Access, these results show important gaps in the ability to bring this care to patients. 

Gravelin, M., Adamo, J., Ellison, S., Segear, E., Parrish, A., Deeter, C., . . . Weatherwax, K. (2023). National landscape assessment of academic medical center support for expanded access to investigational products. Journal of Clinical and Translational Science, 7(1), E4. doi:10.1017/cts.2022.494