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Field Demonstration Research

As described elsewhere, the Policy Research arm of EDICT will address barriers that reside within the health care system in general. The Field Demonstration Research arm of EDICT aims to use identified barriers to clinical trial participation as addressable areas for interventions designed to improve participation. The goal of interventions is to foster better informed decision-making about clinical research among potential participants. Known barriers to participation involving the realms of knowledge, attitudes, beliefs and decision-making skills have been identified. Barriers may exist among clinicians and medical staff, such as study coordinators, as well as among potential participants themselves, their families or others who may have an influence on study participation, and their communities in general.

An obvious opportunity to improve low minority enrollment in clinical research is found at the points of potential study entry. By addressing known barriers at these points with testable interventions, interventions that are successful can be identified and then promulgated to the wider communities of research and clinical medicine. The Field Research Demonstration arm is developing and testing specific interventions to scientifically document their effectiveness in real-world clinical settings.

A moderate amount of research has been done on barriers to research participation among historically underserved populations, and some barriers are by now well-known. However there is a dearth of literature on documented, testable field methods to increase such participation. The Field Research Demonstration arm has selected certain cancers and chronic obstructive pulmonary diseases as target illnesses for which clinical research participation can be increased among historically underserved populations, particularly racial and ethnic minorities. These illnesses are relatively common, show racial and ethnic disparities in incidence and survival, and represent acute and chronic conditions. Therefore improved enrollment into clinical studies on these diseases would have the largest public health impact in terms of recruitment, retention, and the return for society.

By experimentally intervening with newly-diagnosed patients at potential points of study entry, patients can be better-enabled to make an informed choice about research participation. Since clinical trials are at the front line of translating research into practice, participation in clinical trials can be seen as part of clinical care rather than a separate research activity. It is hoped that by testing and finding interventions that are successful, the cycle of medical care, research participation, better medical care will increase.

To properly measure the effect of interventions, The Field Demonstration Research arm will determine clinical trial enrollment rates of target populations in historical, completed clinical trials in the same clinics which will receive interventions. The retrospective arm of the study will gather historical enrollment and retention data, and the prospective arm will determine enrollment and retention rates during a period of the educational interventions for patients as well as for clinicians and medical staff. Enrollment and retention rates in clinical trials will be compared between the retrospective and prospective time periods. Thus the clinic locations and medical specialty will remain constant while the effect of the interventions will be the factor under study. By properly testing and documenting the effect of interventions on study participation scientifically, a sound rationale will be established to inform health policy.