Provider roles in the recruitment of underrepresented populations to cancer clinical trials

Abstract

BACKGROUND.Providers play a vital role in the successful recruitment of underrepresented patients to cancer clinical trials because they often introduce the opportunity of clinical trials. The purpose of the current systematic review was to describe provider‐related factors influencing recruitment of underrepresented populations to cancer clinical trials.METHODS.To find original studies on the recruitment of underrepresented populations to cancer clinical trials, electronic databases from January 1966 to December 2005 were searched; hand‐searched titles in 34 journals from January 2003 to January 2006; and reference lists were examined of eligible articles. Title and abstract reviews were conducted to identify relevant studies. Potential articles were then abstracted using a structured instrument and a serial review process by 2 investigators.RESULTS.Eighteen studies were eligible for review: 13 targeted healthcare providers, 3 targeted patients/participants, and 2 targeted both providers and patients. The study designs included randomized controlled trial, concurrent controlled trial, case‐control, descriptive, and qualitative. A lack of available protocols and/or a lack of provider awareness about clinical trials prevented providers from discussing the opportunity of clinical trials in 2 studies. In 14 studies, patient accrual was affected by provider attitudinal barriers relating to patient adherence to the study protocol, patient mistrust of research, patient costs, data collection costs, and/or patient eligibility. Providers' communication methods were barriers in 5 studies and promoters in 1 study.CONCLUSIONS.A heterogeneous body of evidence suggests that several provider‐related factors influence recruitment of underrepresented groups to clinical trials. Future recruitment efforts should address these factors. Cancer 2007;109:465–476. © 2007 American Cancer Society.

Diversity of participants in clinical trials in an academic medical center

“…DISCUSSION Enrollment in therapeutic clinical trials for cancer is a complex process that is shaped by many factors, both biomedical and social. Although some of the literature on recruitment has addressed the influence of provider attitudes, 7,12,[21][22][23] the current case study illustrates how providers subjectively evaluated social criteria in deciding which patients to recruit for clinical research. In assessing a patient's appropriateness for research, providers sought to balance the patient's clinical needs with their own need to complete trials in a timely fashion by focusing their recruitment efforts on patients who could adhere successfully to complex protocols.…”

“…2,7 Research and interventions have sought to address patient and community factors that impede the recruitment of diverse study participants; it is also important to address clinic-based and provider factors that impede accrual to clinical trials.…”

Early Phase Clinical Trials: Referral Barriers and Promoters among Physicians

“…Physicians act as gatekeepers and provide a majority of patient education regarding clinical trials; therefore, they influence recruitment and patient decision-making. Research has shown that participation and recruitment barriers include physicians' lack of clinical trial awareness, attitudes, level of comfort explaining the trial, fear of losing patients, mistrust of medical institutions and researchers, lack of time and structural support, limited resources for data management, complexity of the study protocol and level of burden, feelings about the patient's age and comorbid conditions, and lack of adequate compensation for involvement [1,2,[8][9][10][11][12][13][14][15][16][17][18][19][20]. Physicians may also feel that referring patients to trials might negatively affect and threaten their relationship with patients, manifesting in patients either blaming the physician for any negative consequences of study participation or threatening the physician's income as patients seek increasing care via trial physicians [17,[21][22][23].…”

“…Physicians may not offer or even discuss clinical trials as a treatment option with minority patients specifically, because they may perceive that these patients face unique barriers: mistrust of researchers and the medical system; lack of interest, awareness/information and resources; insufficient health literacy to understand the trial; and limited protocol compliance [2,8,9,11,12,14,17,20,24]. Other known barriers to the referral of minorities include providers' inadequate language proficiency [20,25,26] and inadequate means of presenting information to patients [2,9,20,24,27].…”

The Impact of Consenter Characteristics and Experience on Patient Interest in Clinical Research

“…These include intrinsic patient characteristics, such as age [3][4][5], gender [3], race [3, 6 -8], and socioeconomic status [6,9]. Additionally, physician characteristics, attitudes toward patients [10], and communication skills [10 -14] have been associated with study accrual rates. However, the role of nonphysician research personnel has not been well studied.…”