Baquet Claudia R, Mishra Shiraz I, Weinberg Armin D
University of Maryland School of Medicine, Baltimore, MD 21201, USA.
J Health Care Poor Underserved. 2009 May;20(2 Suppl):24-39. doi: 10.1353/hpu.0.0156.
This report describes state policy and legislation related to clinical trials participation and Maryland's model to enhance clinical trial availability and participation.
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.
Twenty-four states have mandated clinical trial coverage through specific legislation or agreements since 1994. Covered benefits varied among the states.
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.
本报告描述了与临床试验参与相关的州政策和立法，以及马里兰州提高临床试验可及性和参与度的模式。
基于美国国家癌症研究所（NCI）的州癌症立法数据库、美国癌症协会和NCI的数据，对与临床试验费用覆盖相关的州政策和立法进行描述性回顾；此外，还讨论了马里兰州全面的多层次临床试验模式，该模式包括政策倡议、社区参与、研究、教育和基础设施支持。
自1994年以来，有24个州通过特定立法或协议强制要求覆盖临床试验。各州涵盖的福利各不相同。
除了成本和保险障碍外，还需要解决影响临床试验参与的重要患者、医生和研究人员以及结构性障碍。马里兰州提供了一个全面的模式来解决多方面的临床试验参与决定因素，因为它跟踪州和联邦政策、记录试验障碍并开展社区教育。
