The American Cancer Society Cancer Action Network Welcomes HHS Focus on Streamlining and Strengthening Clinical Research

WASHINGTON, D.C. – Yesterday, the U.S. Department of Health and Human Services (HHS) announced coordinated efforts across multiple agencies within the department to accelerate development of clinical research and remove barriers to clinical trial participation. As part of this initiative, the HHS Office of Inspector General (OIG) is seeking input from the public on whether any additions or modifications are needed to safe harbor regulations under the “Federal Anti-Kickback Statute” (AKS).

For four consecutive years, the American Cancer Society Cancer Action Network (ACS CAN) has led a coalition of organizations urging HHS OIG to create a safe harbor from the AKS statute that would permit sponsors of clinical trials targeting cancer or other life-threatening diseases or conditions to cover certain indirect costs incurred by clinical trial participants without violating the AKS If adopted, the safe harbor could play a critical role in facilitating access to clinical trials for many cancer patients who otherwise face financial and logistical barriers to participating.

The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network, reacting to the announcement:

“The American Cancer Society Cancer Action Network (ACS CAN) applauds the U.S. Department of Health and Human Services for recognizing and seeking to address some of the most complex barriers that prevent patients from being able to participate in clinical trials. We particularly welcome the opportunity to provide information regarding a safe harbor from the Anti-Kickback Statute under which some trial sponsors are hesitant to provide payment for participants for costs associated with clinical trial participation.

“Cancer patients who want to enroll in clinical trials face what can be significant expenses related to costs like travel, parking, lodging, childcare and lost wages incurred as a result of attending appointments related to the clinical trial. These indirect costs can often be a deterrent to trial enrollment and continued participation. 

“ACS CAN looks forward to working with the relevant agencies at HHS to ensure the potential changes announced today help remove barriers for cancer patients to access clinical trials, improving survival and quality of life, and pave the way for innovative and more effective standards of care.”

ACS CAN has long advocated for patient-centric changes to the Anti-Kickback Statute to increase clinical trial enrollment and as recently as February, sent a letter signed by 25 public health organizations urging HHS to allow clinical trial sponsors to financially support patients in order to offset indirect costs associated with clinical trial participation. Read the full letter here.

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