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Area of Science:

  • Oncology
  • Drug Development
  • Health Policy

Background:

  • Expanded Access (EA) has provided an alternative pathway for patients with cancer to access investigational drugs for over 30 years when standard treatments and clinical trials are unavailable.
  • The 2018 federal Right To Try legislation introduced a second, FDA-bypassing pathway for obtaining unapproved drugs outside of clinical trials.
  • The utilization and perceptions of these two distinct pathways by community oncologists and hematologist-oncologists remained unstudied.

Purpose of the Study:

  • To investigate the awareness, utilization, and perceptions of the Expanded Access (EA) program and the Right To Try legislation among community medical oncologists and hematologist-oncologists in the United States.
  • To compare the reported success rates of using EA versus Right To Try for accessing investigational drugs for patients with cancer.

Main Methods:

  • A web-based survey was administered to community oncologists-hematologists across the United States between October 2019 and February 2020.
  • The survey collected data on physicians' awareness, attempts to use, and perceived effectiveness of both the EA and Right To Try pathways for obtaining unapproved drugs for their patients.

Main Results:

  • Out of 238 surveyed physicians, 46% had attempted to use the EA program, while 14% had attempted to use the Right To Try pathway.
  • Success rates for obtaining investigational drugs were higher for the EA program (89%) compared to the Right To Try pathway (73%).

Conclusions:

  • Community oncologists-hematologists demonstrate general awareness of both EA and Right To Try pathways.
  • There is a noted disparity in the utilization and success rates between the EA program and the Right To Try legislation, indicating a need for improved understanding and application of these access programs.