A Descriptive Analysis of State Legislation and Policy Addressing Clinical Trials Participation

Objectives. This report describes state policy and legislation related to clinical trials participation and Maryland’s model to enhance clinical trial availability and participation.

Methods. Descriptive review of state policy and legislation related to coverage for clinical trials costs based on data from the National Cancer Institute (NCI) State Cancer Legislative Database, the American Cancer Society, and NCI; additionally, discussion of Maryland’s comprehensive multilevel clinical trial model comprising policy initiatives, community engagement, research, education, and infrastructure support.

Results. Twenty-four states have mandated clinical trial coverage through specific legislation or agreements since 1994. Covered benefits varied among the states.

Conclusions. Besides cost and insurance barriers, there is a need to address important patient, physician and researcher, and structural barriers to clinical trial participation. Maryland provides a comprehensive model to address the multi-faceted clinical trial participation determinants as it tracks state and federal policy, documents trial barriers, and conducts community education.