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Ask Congress to Eliminate Barriers to Clinical Trial Participation

18 Aug 2022 11:05 AM | Katy Monaco (Administrator)

Please join the Association for Clinical Oncology in supporting the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (H.R. 5030 / S.2706), introduced by Representatives Raul Ruiz, M.D. (D-CA-36) and Larry Bucshon, M.D. (R-IN-8), and Senators Robert Menendez (D-NJ) and Tim Scott (R-SC). This bill would result in more efficient, inclusive, and accessible research that will benefit the health of all patients by allowing trial sponsors to cover ancillary costs of trial participation and issue guidance on how to conduct decentralized clinical trials to improve demographic diversity. The support of this legislation is in alignment with ASCO's State Affiliate Council's priorities. Specifically, the legislation would:

  • Allow individuals to receive financial support for the non-medical costs associated with their participation in clinical trials by creating a statutory safe harbor for trial sponsors to use in reimbursing such costs;
  • Allow trial sponsors to provide individuals with the technology necessary for them to participate remotely in clinical trials. Clinical trials almost always require participants to report their condition, symptoms, side effects, or other data on a regular basis and/or have certain health indicators monitored by web-enabled technology;
  • Require the Department of Health and Human Services (HHS) to issue guidance on decentralized clinical trials. While the COVID-19 pandemic accelerated the need for clinical trials in which patients could participate at or close to home, researchers have long endeavored to make clinical trials more convenient for participants. The decentralized approach could open the door to clinical trials for a much broader array of participants, such as those who live hours from a trial site or do not have the ability to make repeated visits to the trial site due to work or caregiving schedules.

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