title: 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,p0.040). 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,p0.014) 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,p0.001) to consider fatalistic beliefs as an important barrier.
  
  
  CONCLUSIONS
  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.
authors: 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.
authors: Patricia
authors: P
authors: Chalela
authors: Austin, Texas 78703.
authors: Lucina
authors: L
authors: Suarez
authors: 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.
authors: Edgar
authors: E
authors: Muñoz
authors: 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.
authors: Kipling J
authors: KJ
authors: Gallion
authors: Department of Epidemiology and Biostatistics The University of Texas Health Science Center at San Antonio 7703 Floyd Curl Ave., Mail Code 7933 San Antonio, TX 78229-3901.
authors: Brad H
authors: BH
authors: Pollock
authors: The University of Texas Health Science Center at San Antonio Cancer Therapy & Research Center Institute for Drug Development 7979 Wurzbach Road, Room Z459 San Antonio, Texas 78229.
authors: Steven D
authors: SD
authors: Weitman
authors: The University of Texas Health Science Center at San Antonio Cancer Therapy & Research Center Institute for Drug Development 7979 Wurzbach Road, Room Z459 San Antonio, Texas 78229.
authors: Anand
authors: A
authors: Karnad
authors: 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.
authors: Amelie G
authors: AG
authors: Ramirez
keywords: Barriers; Cancer Patients; Clinical Trials; Early phase; Enrollment; Promoters