Recruitment and participation in clinical trials: Socio-demographic, rural/urban, and health care access predictors

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Abstract

Background: Recruitment and participation in clinical trials by minorities, particularly African Americans and rural underserved populations, are low. This report examines predictors of clinical trial recruitment and participation for adult Marylanders. Methods: A cross-sectional design was used to survey 5154 adults (18 years and older) residing in 13 of the 24 jurisdictions in Maryland, including urban Baltimore City, and the rural regions of Western Maryland and the Eastern Shore. The survey, conducted between December 2001 and March 2003, used Computer-Assisted Telephone Interviewing and random-digit dialing procedures. Primary dependent variables included “ever asked to participate” (i.e., recruited) and “participated” in clinical trials. Results: 11.1% of the respondents had been recruited to clinical trials. In addition, 59.4% of the respondents recruited to clinical trials actually participated in a clinical trial. Among respondents recruited to clinical trials, black and middle income respondents were significantly less likely to actually participate in clinical trials; whereas, respondents who received information about clinical trials from their health care provider, who were knowledgeable about clinical trials, and those who had the time commitment were significantly more likely to participate in clinical trials. Conclusions: These results suggest serious gaps in efforts to recruit racial/ethnic minorities and residents of rural regions into clinical trials. The findings provide the basis for the development and implementation of community-based educational programs for both the general public and health care professionals, and to enhance availability of community-based clinical trials, especially in the rural areas of the state.

Introduction

Clinical trials are a critical resource for the discovery of new prevention, diagnostic and treatment modalities for disease. For cancer, clinical trials have produced advances in treatment as well as prevention. Despite these advances in cancer prevention and patient care, only about 3–5% of cancer patients participate in clinical trials [1], [2].

Assuring diversity in clinical trial participation is a national priority. In 1993, the most recent amendment to the National Institutes of Health (NIH) Revitalization Act (Public Law 103-43) [3], mandated the inclusion of women and minorities in clinical research and government sponsored human subject research including clinical trials. This Act states that women and minorities must be included in all clinical research studies and must be included in Phase III clinical trials. Trials must also be designed to permit valid subgroup analyses. The Act states that cost is not an allowable reason for excluding minorities and that the NIH will support outreach efforts to fulfill this mandate. However, for communities that experience high cancer burden as demonstrated by elevated cancer incidence and mortality rates, such as African Americans, the uninsured and poor, and rural patients, participation in cancer clinical trials is particularly low [2], [4], [5]. Moreover, the proportion of trial participants who are African Americans has declined in recent years [5].

Participation in clinical trials is affected by individual (patient and provider) and structural factors. Some evidence suggests that slightly less than one-third (32%) of Americans would be willing to participate in clinical trials if asked, and, an additional 38% would be inclined to participate if asked but had some questions or reservations [1]. Therefore, factors other than patient intent or willingness seem to impede participation in clinical trials. Some of the salient factors impeding participation in clinical trials include: being a racial minority [2], [5], [6], [7]; older age [2], [5], [7], [8], [9]; lower socioeconomic status [2], [6], [7], [10], [11]; lack of appropriate clinical trials and the disqualification of patients [1]; the reluctance of physicians to engage in accrual [1], [12]; doctor–patient communications regarding clinical trials [7], [10], [13]; mistrust of academic institutions, research and the medical system [6], [10], [12], [14], [15], [16], [17]; fear of negative effects [11]; lack of community and physician awareness and knowledge of clinical trials benefits [10], [11], [18]; lack of sufficient infrastructure (including oncologists and approved cancer programs) to support trials in community settings [2]; lack of researcher training in culturally appropriate patient concerns and communication methods [13], [17], [19]; certain historical factors [14]; lack of adequate support for community outreach; poor access to care [12]; lack of information on available trials [10], [12].

The low participation in cancer trials by African Americans and other minorities may contribute to existing cancer survival and mortality rate disparities. These avoidable disparities in cancer research participation are a public health problem in that access to cutting edge advances in cancer prevention and therapy are not equitably available to those populations experiencing substantially higher cancer incidence, morbidity and mortality rates [20]. While numerous studies discuss issues related to the low participation of African Americans in trials, very few discuss possible predictive factors associated with trial participation. The focus of this report is two-fold: first, to present the prevalence of clinical trial recruitment and participation in three regions of Maryland; second, to determine multivariate socio-demographic, rural/urban geography, source of clinical trial information, enabling factors, and health care access predictors of recruitment and participation. The results from this analysis will be used to document geographic and population-specific barriers and channels for clinical trial education and promotion. Moreover, the report's findings would serve as the basis for the development of educational programs to increase participation in trials and also facilitate the identification of key areas for education and outreach programs to promote greater knowledge and awareness of key facts on trials. Ultimately, it is hoped that greater awareness and intensive educational programs will increase the availability and likelihood of participation in clinical trials by urban, rural and minority underserved patients.

Section snippets

Methods

The data are derived from a larger investigation on the health behavior, health care access, and screening and health status conducted in 13 of the 24 jurisdictions in the state of Maryland between December 2001 and March 2003 [21]. The 13 jurisdictions studied included urban Baltimore City, the three counties of rural Western Maryland (Garrett, Allegany, and Washington counties), and the nine counties of the rural Eastern shore (Cecil, Kent, Queen Annes, Talbot, Caroline, Dorchester, Wicomico,

Sample characteristics

The sample consisted of 5154 adults surveyed in urban Baltimore City (n = 681), rural Western Maryland (n = 1122), and rural Eastern Shore (n = 3351). Overall, the majority of adults surveyed were less than 65 years of age (74.7%), white (79.2%), female (53.1%), considered themselves in “not poor” health (94.6%), high school graduate (34.7%) or with some college (25.4%) level of education, with health insurance coverage (90.6%), and with an annual income of less than US$ 50,000 (59.7%). There were

Discussion

Enhancing recruitment and participation in clinical trials, especially for minorities, is a national priority. Addressing avoidable disparities in participation requires better understanding about the specific factors that may lead to recruitment and participation. The results presented in this report shed light on factors associated with clinical trial recruitment and participation in a population-based, rural and urban sample covering 13 of the 24 jurisdictions in the state of Maryland.

Acknowledgments

This research was supported by grants from the National Cancer Institute (1UO1CA86249-01), the National Center for Minority Health and Health Disparities (P60MD000532), and the Maryland Cigarette Restitution Fund Program. The contents of the article are solely the responsibility of the authors and do not necessarily represent the views of the funding agencies. The authors acknowledge the outstanding biostatistical contributions provided by Fanlun Meng.

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