BackPack and CLAS-ACT: Eliminating disparities in clinical trials

The number of individuals admitted to clinical trials has increased while minority participation has remained stable, resulting in a proportionate decrease of minorities participating in clinical trials. Since the disease burden disproportionately affects racial and ethnic minorities, it is imperative to have them appropriately represented in clinical trials to both learn about their potential differences in treatment protocols, and also increase access to state of the art treatments for these populations. In May 2007, the Office of Minority Health (OMH) at the U.S. Department of Health and Human Services joined with the Eliminating Disparities in Clinical Trials (EDICT) project to address this service delivery gap. The OMH and EDICT, a joint project of the Baylor College of Medicine and the Intercultural Cancer Council (ICC), launched the development of the Culturally and Linguistically Appropriate Standards and Clinical Trials (CLAS-ACT) and BackPack projects. CLAS-ACT adapts the National Standards on Culturally and Linguistically Appropriate Services (CLAS) to clinical research to improve the standards' consistent and systematic utilization. The BackPack is a resource to identify best or promising practices and policies in minority recruitment and retention in clinical trials. Both BackPack and CLAS-ACT will be powerful tools to eliminate disparities in clinical trials.