The American Cancer Society Cancer Action Network and 128 other patient advocacy and professional groups submitted a comment letter Aug. 24 urging HHS’ Office of Inspector General to create a safe harbor under the federal anti-kickback statute allowing clinical trial sponsors to cover participants’ travel, lodging and other expenses without risking fraud and abuse liability.
The letter responds to a request for information the inspector general published June 24 as part of HHS’ Operation TrialBlazer initiative, which aims to reduce regulatory barriers to clinical trial development. ACS CAN and its co-signers argue the anti-kickback statute and beneficiary inducements provisions of the civil monetary penalty law currently discourage sponsors from covering costs such as transportation, lodging, childcare and modest stipends. The groups said the regulatory uncertainty adds to existing barriers to trial participation, particularly for rural and lower-income patients.
The letter cites data showing nearly 38% of the U.S. population older than 35 must drive more than 50 miles to reach an NCI-funded trial site. Lower-income patients traveled an average of 238 miles to participate in a trial, compared with less than 50 miles for middle- and higher-income patients. An appendix analysis found wide disparities between states’ cancer incidence and access to clinical trials. West Virginia, for example, ranks second nationally for cancer incidence but 47th for clinical trial availability within 100 miles of the state capitol.
The push for expanded trial access comes as health systems have been building out infrastructure to decentralize and scale clinical trial access. Charlotte, N.C.-based Advocate Health, for example, launched a systemwide National Center for Clinical Trials aimed at embedding research into routine care across its 69 hospitals and nearly 6 million patients.
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