Representation of minorities in randomized lung cancer trials in the United States.

Abstract

e16517 Background: The SEER data base shows a higher rate of lung cancer mortality for African Americans and a lower lung cancer mortality rate of Hispanics compared to Caucasians in the US. It is not clear if this is due to socioeconomic or biological factors. This study reviews the representation of Caucasians, African Americans (AA), Hispanics, and Asians in recent randomized trials published in the US. Methods: A systematic review was done of randomized trials in lung cancer published in the NEJM, JAMA, JCO. The percentage of patients of each race in the individual trials was listed. An average percentage with mean standard error for Caucasian, African-American, Hispanic and Asian race was obtained. The percentage for each group is compared to the racial distribution in the US Census data. Results: 30 randomized clinical trials were analyzed for racial distribution. A total of 227,411 patients were enrolled in the trials. Conclusions: African Americans and Hispanics have been significantly underrepresented in randomized trials published in the US. This affects the external validity of the trial results when generalizing the results to these minorities. Strategies to ensure accrual of people of all races are required to ameliorate the disparities clinical trial enrollment. [Table: see text]