Amelie G. Ramirez, DrPH¹, Eric Rowinsky, MD², Bradley Pollock, PhD³, Kipling J. Gallion, MA⁴, Patricia Chalela, MPH⁴, and Sandra San Miguel, MPH⁴. (1) Dept. of Medicine, Baylor College of Medicine, 8207 Callaghan Rd., Suite 110, San Antonio, TX 78230, 210 348 0255, aramirez@bcm.tmc.edu, (2) Institute for Drug Development, Cancer Therapy and Research Center, 14960 Omicron Drive, San Antonio, TX 78229, (3) Center for Epidemiology and Biostatistics, The University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr., CTRC U470, San Antonio, TX 78229, (4) Chronic Disease Prevention and Control Research Center, Dept. of Medicine, Baylor College of Medicine, 8207 Callaghan, #110, San Antonio, TX 78230

Advances in cancer treatment require the investigation of new therapeutic agents in early phase clinical trials (EPCTs), but low accrual rates are a major problem especially among Hispanics. Without adequate minority participation in EPCTs researchers cannot assess differential effects among groups nor ensure the generalizability of trial results. This South Texas study is developing an intervention for local oncologists and Hispanic cancer patients to increase EPCT participation. A social assessment phase is currently underway that includes focus groups with cancer patients and interpersonal interviews with oncologists. Discussion topics are informed from limited literature on EPCT barriers. Therefore, the exploratory open forum provided by the focus groups will be important in confirming and expanding on the known issues and revealing new and potentially significant barriers to trial participation. A preliminary list of topics (barriers) drawn from the literature and anecdotal conversations with EPCT staff will form the start of discussions with patients and oncologists. The results will be available by the summer of 2004 and will examine the social, cultural and structural barriers that confront each of these groups. These data will be used to expand the literature on issues surrounding recruitment to EPCTs, particularly for Hispanic cancer patients, as well as providing information on the oncologists involved in those patients’ care. This session will review the assessment process, it’s results and provide implications for development of a culturally sensitive intervention trial to overcome barriers to EPCT’s among Hispanics.

Learning Objectives:

• Remember that for genetic studies, the environment/gene interaction is considered most responsible for genetic alterations that lead to disease. Hispanics are disproportiately exposed to environmental risk due to occupation and low income living conditions. CT's that successfully recruit Hispanics, will have greater chances to improve the longterm health of Hispanics.

Keywords: Clinical Trails, Hispanic

Related Web page: www.saludenaccion.org/Projects/genetics.html

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.