Clinical Trials Program at Metropolitan Nashville General Hospital

Harold L. Moses, M.D.African Americans participate in clinical trials far less frequently than do non-Hispanic whites. Mistrust and poor communication are among the barriers persistently identified by health disparities research. However, a program developed at Nashville General Hospital that targets some of these barriers provides 7 years of evidence that recruitment rates can be dramatically increased, according to results presented this week at the AACR annual meeting in Denver.

The hospital is part of Meharry Medical College, the first medical school in the South for African Americans and part of the NCI-funded Minority-Based Community Clinical Oncology Program (MB-CCOP). Meharry participates with the Vanderbilt-Ingram Cancer Center in one of NCI’s comprehensive partnerships, where minority-serving institutions that work primarily in the community setting forge an alliance with a major academic NCI-designated cancer center.

Since the Meharry-Vanderbilt partnership was established in 2000, researchers from the institutions have been developing a systematic model to increase enrollment by African Americans in appropriate cancer clinical trials.

The study involved 1,125 African American patients newly diagnosed with cancer and screened between 2001 and 2007. While the national average for African American participation in clinical trials is between 2 and 4 percent, the program at Meharry was able to enlist into trials up to 25 percent of all patients who were interviewed.

From 2001 to 2004, 569 patients were screened by the newly trained researchers, who were part of the permanent medical staff and fully integrated into the provision of clinical care. While only 164 were matched to a study, 95 agreed to enroll. This was 17 percent of those screened, but 58 percent of those who were eligible.

After an evaluation of these results, the researchers refined their techniques and began a new dataset in 2005. Through 2007, of 556 patients screened, 80 percent (138 of the 172 patients deemed eligible) agreed to participate in a trial. Combining the two datasets over 7 years, 68 percent of those eligible agreed to participate.