Eliminating the Financial Burden for Patients
The Equitable Access to Clinical Trials (EACT) project provides a forum for sharing best practices and fosters collaborative action to advance financial neutrality for patients participating in clinical trials.
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By “financial neutrality,” we mean reducing or removing non-medical, out-of-pocket costs to clinical trial participants through financial support programs offered by the trial sponsor (or other entity). These may be costs associated with travel, lodging, meals, lost wages, and care of children, elders, and pets for patients and/or caregivers.
Patients cite cost as a top reason for declining clinical trial participation. The role that financial considerations play in influencing someone’s decision to join and/or stay in a study differs according to a range of factors: geography, personal support network, employment and/or government assistance status, and more. Without comprehensive, explicit regulatory guidance on the acceptability of financial support for trial participants, sponsor and IRB interpretations of what is fair, compliant, and achievable will continue to vary.
The initiative, hosted by LUNGevity Foundation, consists of a steering group and three working groups tasked with:
—Identifying best practices and defining industry consensus standards for reimbursement programs
—Defining and clarifying tax and legal issues with reimbursement programs
—Expanding efforts to educate patients and healthcare providers about the availability of reimbursement.
Resources
Advancing Equitable Access to Clinical Trials: Eliminating the Financial Burden for Patients
Best practice considerations and recommended approaches for sponsors
Participant Needs Assessment and Discussion Guide
A tool to aid clinical trial site personnel in determining patients’ assistance needs and directing them to resources
Engaging with Sponsors About Financial Support Programs for Participants
A checklist to help clinical trial staff ensure that study participants get the support they need
Steering Group
Wendy Selig, WSCollaborative
Chelsea Backler, Oncology Nursing Society
Elizabeth Barksdale, LUNGevity Foundation
Barbara Bierer, Multi-Regional Clinical Trials Center
Colleen Cook, Mirati/Bristol Myers Squibb
Willyanne Decormier Plosky, Multi-Regional Clinical Trials Center
Gissoo Decotiis, Daiichi Sankyo
Elizabeth George, LabCorp
David Gerber, UT Southwestern Comprehensive Cancer Center
Cecile Gonzalez-Cerimele, Lilly
Keri McDonough
Erin Miller, Lazarex
Diana Pankevich, Pfizer
Sandra Shaw, Mirati/Bristol Myers Squibb
Marc Taylor, Pfizer
