Promoting Factors and Barriers to Participation in Early Phase Clinical Trials: Patients PerspectivesPatricia Chalela1, Lucina Suarez1, Edgar Muñoz1, Kipling J Gallion1, Brad H Pollock2, Steven D Weitman3, Anand Karnad3 and Amelie G Ramirez1*
- Corresponding Author:
- Amelie G Ramirez
Institute for Health Promotion Research
The University of Texas Health Science Center at San Antonio
7411 John Smith Dr., Suite 1000, San Antonio, TX 78229, USA
E-mail: [email protected]
Received Date: October 19, 2013; Accepted Date: April 21, 2014; Published Date: April 24, 2014
Citation: Chalela P, Suarez L, Munoz E, Gallion KJ, Ramirez AG, et al. (2014) Promoting Factors and Barriers to Participation in Early Phase Clinical Trials: Patients Perspectives. J Community Med Health Educ 4:281. doi:10.4172/2161-0711.1000281
Copyright: © 2014 Chalela P, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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 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 regressions 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=1.30-9.97, 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 language 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.