Redes Researchers Launch Early Phase Trial Study

Early phase trial study

January 26, 2004.

By addressing cultural and other barriers to early-phase clinical trial participation, a two-year study recently initiated in South Texas will benefit both cancer patients and research oncologists.

The research project, "Increasing Early Phase Clinical Trial (EPCT) Accrual Among Hispanics in South Texas," will identify barriers to Latino participation in clinical research and develop interventions to help reduce these obstacles. Early-phase (Phase I and II) clinical trials determine which experimental cancer prevention and treatment agents show promise for testing in larger, randomized trials.

"Increased participation in these clinical trials by Latinos means greater opportunity for cutting-edge treatment for Latino cancer patients," said Amelie G. Ramirez, DrPH, Principal Investigator (PI) of the study, as well as PI of Redes En Acción. "In addition, it provides a much-needed boost for underrepresented population accrual rates for investigators who are leading these clinical research studies."

The research project represents a partnership between the federal government and the private sector. The study is one of several at institutions around the country that combine funding from the National Cancer Institute and a consortium of pharmaceutical companies to help clinical and comprehensive cancer centers increase participation among underrepresented and older patient populations in early-stage clinical trials. Participating private sector partners are Aventis, Novartis, Eli Lilly and Company, GlaxoSmithKline and Bristol-Myers Squibb.

The partnership's goal is to develop replicable models that NCI cancer centers and other organizations can use to raise early-phase clinical trial accrual rates among members of underrepresented and aging populations. The rapid growth of both of these population groups underscores the need for greater representation in future cancer research efforts.

Under the direction of Dr. Ramirez and Co-Principal Investigators Brad Pollock, PhD, MPH, from the University of Texas Health Science Center at San Antonio and Eric Rowinsky, MD, from the Cancer Therapy and Research Center, investigators will research clinical trial participation barriers through patient focus groups and interviews, as well as interviews with area oncologists.

Based on information gained from cancer patients and oncologists, researchers will identify the most relevant barriers to early trial participation by South Texas area cancer patients and determine strategies for overcoming the obstacles. The study will incorporate those strategies into an intervention model. Plans call for field-testing the model in a subsequent research study.

What Is Redes En Acción? Redes En Acción is a major NCI-supported initiative to combat cancer among Latinos through a nationwide network of community-based organizations, research institutions, government health agencies and the public. Core activities include promoting cancer training and research opportunities for Latino students and researchers, generating research projects on key Latino cancer issues, and supporting cancer awareness activities within the Latino community.

The initiative is coordinated by the Baylor College of Medicine in Houston and San Antonio, with regional network centers in San Antonio, New York, Miami, Chicago, San Francisco and San Diego.