Abstract
B12
In 1993 the NIH Revitalization Act was enacted, and it requires applicants for federal research funding to provide a strategy for inclusion of people of diverse racial and ethnic origin and women into clinical trials. In spite of the Revitalization Act, current research indicates that underrepresented groups are still not adequately represented in cancer clinical trials. According to the Coalition of Cancer Cooperative Groups, 89% of participants enrolled in NCI clinical trials between January 2003 and June 2005 were white. In addition to the clear emphasis of the Belmont Report on equity and justice in both burdens and benefits of clinical research, social justice has not been achieved when it comes to inclusion of the underrepresented in cancer clinical trials. Without adequate representation of these populations in clinical trials, researchers cannot learn about differences in safety and efficacy between groups and cannot ensure generalization of scientific results. This also contributes to health disparities by keeping the newest techniques and drugs out of the reach of the disadvantaged groups. This concern for the overwhelming underrepresentation of diverse groups in cancer clinical trials specifically, has led to the development of the EDICT (Eliminating Disparities in Clinical Trials ) Project*, a joint project between Baylor College of Medicine and the Intercultural Cancer Council. The EDICT mission is to address problems and solutions related to improving the participation of minority and underserved populations in clinical trials. The underlying premise of the EDICT Project is the need for a change in how we design and oversee clinical research so that there is accountability and enforcement for equitable inclusion in clinical trials, and fostering research design which takes into account not only equitable participant accrual, but also differential plans for retention of underrepresented populations. One early focus of EDICT has been policy research, while ongoing EDICT field demonstration research will test the effect of various interventions on participant accrual and retention rates in clinical trials when applied to underrepresented populations, as compared to no intervention. It is anticipated that the outcomes of the EDICT Project will benefit all of the underserved, whether the reason for underrepresentation be race, ethnicity, elderly status or rural domicile. * Funded by Genentech, Inc.
First AACR International Conference on the Science of Cancer Health Disparities-- Nov 27-30, 2007; Atlanta, GA