Eliminating the Financial Burden for Patients

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.