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Results

Impact is everything.

Landscape Assessment

Large academic medical centers support a lot of clinical trials, but how many support Expanded Access? TEAMSS surveyed 47 academic medical centers affiliated with the Clinical and Translational Science Awards (CTSA) consortium. 

The results? Virtually all academic medical centers surveyed used single-patient expanded access, and the majority offered some degree of support. This support focuses primarily on the initial submissions, so we hope our resources for follow-up submissions, annual reports, and closing the IND will be helpful.

 

Key Takeaways for Physicians:

  • If you are at an academic medical center, there is probably help for requesting expanded access available.
  • The most likely offices to support these requests are within the Institutional Review Board (IRB), the Office of Regulatory Affairs, Clinical and Translational Research Institute, or Cancer Center Research Office.

Key Takeaways for Institutions:

  • Physicians are less likely to have support in their regulatory responsibilities after treatment starts. See our Navigating Expanded Access: Steps 8-10 for resources and templates for these submissions.
  • Many institutions lack the systems to track what Expanded Access is being used by their affiliated physicians. See our Navigating Expanded Access: Step 2 for institutional considerations and recommendations on these tracking systems.

View the full results from the Journal of Clinical and Translational Science: Gravelin M, Adamo JE, Ellison S, Segear E, Parrish AB, Deeter C, Hamill J, Rigan L, Mashour GA, Weatherwax KJ. National landscape assessment of academic medical center support for expanded access to investigational products. J Clin Transl Sci. 2022 Nov 16;7(1):e4. doi: 10.1017/cts.2022.494. PMID: 36755539; PMCID: PMC9879891.

Also available open access through PMC Pubmed Central: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9879891/