Enrollment disparities in clinical trials improved between 1990 and 2012 for female and elderly patients with lung cancer, according to an article published in the Journal of Clinical Oncology.1 This improvement was not, however, reflected for minority patients.
The National Institutes of Health (NIH) Revitalization Act of 1993 was implemented to ensure that women and minorities were represented in research funded by the NIH. If the diversity of representation is greater, research can be more effectively generalized.
Researchers evaluated enrollment statistics of 23,006 patients with lung cancer from 210 National Cancer Institute (NCI) clinical trials. Although lung cancer occurs most often among the elderly, between 1990 and 1993, 1600 patients younger than 70 were enrolled to clinical trials; only 392 patients older than 70 were enrolled.
Between 2010 and 2012, however, 679 patients younger than 70 and 299 patients older than 70 were enrolled, reflecting a rise of enrollment for elderly patients from 19.7% to 30.6%. The percentage of women enrolled increased by about 9% in the same timeframe.
These improvements were not found for minority patients. Elderly women are also still underrepresented in small cell lung cancer studies.
The authors conclude that although the NIH Revitalization Act of 1993 improved some disparities of enrollment, there are populations still underrepresented in NCI clinical trials. Subgroup examination in statistical analyses is recommended to improve study generalizability.
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Study limitations included low numbers of minority patients evaluated, which may have skewed results, and that only statistics from NCI studies were used.
- Pang HH, Wang X, Stinchcombe TE, et al. Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012. J Clin Oncol. 2016 Sep 19. doi: 10.1200/JCO.2016.67.7088 [Epub ahead of print]