Promoting Factors and Barriers to Participation in Early Phase Clinical Trials: Patients Perspectives

Abstract

Background Inclusion of minorities in clinical research is an essential step to develop novel cancer treatments, improve health care overall, understand potential differences in pharmacogenomics and address minorities’ disproportionate cancer burden. However, Latinos and other minority groups continue to be critically underrepresented, particularly in early-phase clinical trials (EPCTs). The objective of the present study was to explore barriers and promoting factors influencing patients’ decisions to enroll or not in early phase clinical trials (EPCTs) and identify areas for intervention to increase minority enrollment into clinical research. Methods An interviewer-administered survey was conducted with 100 cancer patients in the predominantly Latino region of South Texas. Exploratory factor analysis was conducted to identify underlying dimensions, and multiple logistic regression assessed significant factors that promote or deter patients enrollment to EPCTs. In addition, a separate subgroup mean analysis assessed differences by enrollment status and race/ethnicity. Results For one standard deviation increase in the importance given to the possibility of symptoms improvement, the predicted odds of refusing enrollment were 3.20 times greater (OR=3.20, 95% CI=1.06–9.71, p 0.040). Regarding barriers, among patients who considered fear/uncertainty of the new treatment a deterrent to enrollment, one standard deviation increase in agreement with these barriers was associated with a 3.60 increase (OR=3.60, 95% CI=1.30–9.97h, p 0.014) in the odds of not being enrolled in an EPCT. In contrast, non-enrolled patients were less likely (OR=0.14, 95% CI=0.05–0.44, p 0.001) to consider fatalistic beliefs as an important barrier. Conclusion This study, one of the first to identify South Texas patients’ barriers to enroll in EPCTs, highlights potential focal areas to increase participation of both minority and non-minority patients in clinical research. Culturally tailored interventions promoting patient-centered care and bilingual, culturally competent study teams could solve common barriers and enhance Latinos’ likelihood of joining clinical trials. These interventions may simultaneously increase opportunities to involve patients and physicians in clinical trials, while ensuring the benefits of participation are equitably distributed to all patients.

Culturally Competent Strategies for Recruitment and Retention of African American Populations into Clinical Trials

“…We believe that most of these barriers can be overcome by using appropriate and culturally sensitive strategies with regard to recruitment. In addition, adequate minority representation in clinical trials is important if differential effects among diverse groups are to be assessed and for the results to be generalized …”

“…Historically, African Americans and other minority groups were largely excluded from clinical trials until the National Institutes of Health (NIH) mandated the inclusion women and minorities in studies yet African Americans and other minority groups continue to be underrepresented in trials . Some of the major reasons cited for excluding minorities, as noted by include, “the difficulty of recruitment and retention, a general belief that racial populations are essentially monolithic, without significant differences, and the desire and need to focus on optimizing internal validity” (p. 1345) …”

Adaptation of a Cancer Clinical Trials Education Program for African American and Latina/o Community Members

“…E. Ford et al, 2013). It has been recommended that strategies for increasing minority CCT participation should be tailored to specific populations, include education tools directed to underserved populations, and emphasize culturally and linguistically appropriate education (Chalela et al, 2014; Christian & Trimble, 2003; Springfield, 2010; Symonds, Lord, Mitchell, & Raghavan, 2012). This project aimed to adapt a promising, single-session intervention designed to increase knowledge and improve attitudes toward CCT participation for African Americans and Latinas/os and to test the feasibility of delivering the adaption in the context of the adapting site.…”

Participation of underrepresented minority children in clinical trials for Fragile X syndrome and other neurodevelopmental disorders

“…With this rise, a push towards potential targeted treatments for neurodevelopmental disorders has led to multiple Phase II clinical trials for children with neurodevelopmental disorders including Fragile X syndrome (FXS) (9) and autism (10). Although several studies have proffered reasons for the relative absence of URM among clinical trial participants (11)(12)(13) to our knowledge none have specifically looked at participation of children with neurodevelopmental disorders. Here we present a small cross-sectional survey of factors associated with participation in clinical trials for children with FXS syndrome and other neurodevelopmental disorders.…”