Making Clinical Trials Participation Free for Patients

May 13, 2019

People who enroll in a clinical trial might be drawn to unexplored treatment options.  Or inspired by the prospect of advancing new cures and medicines that could help patients like themselves.  But few anticipate the costs of participating in a “free” trial – incidental expenses like parking, lodging, child care and meals away from home.  Still fewer may understand the resources available to help cover those costs.

This year, the Coalition for Clinical Trials Awareness hopes to change that.

Raising awareness of available resources for clinical trials expenses is at the heart of the organization’s Clinical Trials Awareness Week, May 13-17.  Each year the week provides opportunities to examine a critical issue related to clinical trials – the need for more infants and seniors in clinical trials, for example, or the question of whether mentioning trials should become standard of care.

This year, Clinical Trials Awareness Week examines the incidental costs associated with trial participation, how these costs can deter enrollment, and what policymakers can do about it.  In some cases, resources are available to reimburse patients for expenses – but patients don’t know about them, or trial staff struggle to allot them as needed. In other cases, reimbursement from private foundations exists, but patients have no way of knowing about that option.  

In some instances, providing funds for clinical trials participants can be confused with coercion.  Last year the Food and Drug Administration issued clarification on the issue, explaining to institutional review boards and clinical investigators that it’s acceptable to reimburse participants for related expenses.  “FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence,” the agency explains on its website.

Several states have taken the issue a step further.  California and Pennsylvania both passed laws in 2018 to cover clinical trials expenses for cancer patients.  

“We can’t have unexpected expenses deter otherwise qualified and willing participants to help advance research,” remarked David Charles, MD, clinical researcher and steering committee member of the Coalition for Clinical Trials Awareness.  The group hopes the week will raise awareness about the resources that exist for patients in clinical trials – and encourage policymakers to continue making progress on laws that prevent unexpected expenses from impeding clinical trials enrollment.

To learn more about the week’s events and the issue of reimbursement for clinical trials-related expenses, visit cctawareness.org/ctaw-2019/ .

Categorized in: