Project Title: Overcoming Barriers to Early Phase Clinical Trials (EPCT): Increasing EPCT Accrual in South Texas

Abstract:

Advances in cancer treatment are critically tied to the investigation of new therapeutic agents in early phase clinical trials. A significant barrier to progress has been the low participation rate into these trials, especially among minority populations. Increasing minority accrual is critical to the development of novel cancer treatments. Without adequate minority participation in early phase clinical trials, researchers cannot assess differential effects among groups nor ensure the generalizability of trial results. The San Antonio Cancer Institute (SACI) is an NCI-designated Cancer Center located in South Texas that services a culturally and ethnically diverse population, largely Hispanic/Latino that historically has had a low participation rate into early phase clinical trials. The goals of the project are to identify the cultural, economic, and structural barriers to early phase clinical trial participation faced by patients and oncologists and to develop an experimental intervention trial to reduce these barriers and increase participation in drug development trials.

PI:

  • Amelie G. Ramirez, DrPH, Professor of Medicine and Deputy Director of the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine

Co-PI's:

  • Christopher Takimoto, MD, Institute for Drug Development (IDD), Cancer Therapy and Research Center (CTRC), San Antonio Cancer Institute
  • Brad H. Pollock, MPH, PhD, University of Texas Health Science Center at San Antonio (UTHSCSA), San Antonio Cancer Institute

Funding Institution:

National Cancer Institute (NCI)

Funding Period:

2 yrs. – 2003-2005

Location/Service Area:

Bexar County, Texas

Collaborators/Co-sponsors:

  • Baylor College of Medicine
  • San Antonio Cancer Institute
  • Cancer Therapy Research Center
  • University of Texas Health Science Center of San Antonio

Goals:

To develop an experimental intervention that would increase participation and reduce barriers among patients and healthcare personnel to participation in Phase 1 clinical trials.

Results:

The patient and oncologist interviews have been completed. After a thorough review of field conditions, it was decided that it was necessary to modify the original protocols and determined that it was statistically feasible to reduce the patient survey sample size to 50 subjects per condition (50 CT participating and 50 non-CT participating patients).

A total of 367 eligible oncologists listed in the Texas Medical Association membership were mailed a study packet containing a cover letter, consent form, questionnaire and self-addressed, stamped envelope. The final oncologist survey response rate of 31% (114 participants) exceeded the anticipated response rate of 20% (74 participants).

Potential Impact:

Cultural, economic, and structural barriers leading to low numbers of diverse participants in clinical trials will be identified, and strategies to overcome these barriers will be developed. Implementation of these strategies will aim to increase the number of racial/ethnic minority participants in early phase clinical trials. This will help expedite the development of novel cancer treatments, as well as improve the generalizability of clinical trial results to racial/ethnic minority populations.

Publications:

Manuscripts Under Development:

  • Barriers to early phase clinical trials: Patient phone interview results, Ramirez AG, et al
  • Barriers to early phase clinical trials: Oncologist survey results, Ramirez AG, et al
  • Barriers to early phase clinical trials: Patient survey results, Ramirez AG, et al