Independent Articles
Assessing Federal Policies to Reduce Economic Barriers to Clinical
Trial Enrollment
Daniel Albert-Rozenberg1, David Peloquin2, Joseph Liss3, Erika Hanson4 and Barbara E. Bierer5,6
1Quinn Emanuel Urquhart and Sullivan LLP, Boston, Massachusetts, US; 2Ropes & Gray LLP, Boston, Massachusetts, US; 3Hogan Lovells, Washington, District of
Columbia, US; 4Harvard Law School, Center for Health Law and Policy Innovation, Cambridge, Massachusetts, US; 5Brigham and Women’s Hospital, Boston,
Massachusetts, US and 6Harvard Medical School, Massachusetts, US
Abstract
The risk of losing access to crucial means-tested programs— like Medicaid, Supplemental Security Income (SSI), the Supplemental Nutrition
Assistance Program (SNAP), and Temporary Assistance for Needy Families (TANF)— poses a barrier to the enrollment of low-income
Americans in clinical trials. This burden likely disproportionately affects members of racial and ethnic minority groups, people with disabilities,
elderly individuals, and rural populations, and may frustrate efforts to reflect the US population in clinical trial enrollment. To help achieve
representative clinical trials for myriad conditions, Congress should pass legislation excluding payments to clinical trial participants from gross
income and expand the clinical trial compensation exclusions for means-tested programs established in the Ensuring Access to Clinical Trials
Act of 2015.
Keywords: Entitlement Programs; means-tested; clinical trials; representation
Open-access on FirstView: Assessing Federal Policies to Reduce Economic Barriers to Clinical Trial Enrollment
by Daniel Albert-Rozenberg, David Peloquin, Joseph Liss, Erika Hanson, and Barbara E. Bierer.
#EntitlementPrograms #ClinicalTrials #MeansTesting
www.cambridge.org/core/journal...