%0 Journal Article
%T Representation of Minorities and Women in Oncology Clinical Trials: Review of the Past 14 Years
%A Aaron S. Mansfield
%A Alex A. Adjei
%A C
%A Jesus Vera Aguilera
%A Joleen M. Hubbard
%A Jonas Paludo
%A Konstantinos Leventakos
%A Miguel Gonzalez Velez
%A Narjust Duma
%A Ronald S. Go
%A Yucai Wang
%A ace L. Haddox
%J General Information | Journal of Oncology Practice
%D 2018
%R https://doi.org/10.1200/JOP.2017.025288
%X INTRODUCTION Section: ChooseTop of pageAbstractINTRODUCTION <<METHODSRESULTSDISCUSSIONREFERENCES The National Institutes of Health (NIH) Revitalization Act of 1993 was created to encourage investigators to increase the representation of women and minorities in clinical trials.1 Despite multiple efforts lead by the NIH and other governmental institutions, minority, elderly, and female patients remain underrepresented in cancer clinical trials.2 One study from 1996 reported equal representation of minorities in National Cancer Institute (NCI)¨Csponsored trials.3 However, this was followed by multiple publications reporting poor enrollment of these subgroups of patients in cancer clinical trials. The most recent study on this topic, conducted by Murthy et al,2 reviewed all NCI cooperative group clinical trials for breast, colorectal, lung, and prostate cancer from 1996 to 2002. Results showed that racial and ethnic minorities, women, and the elderly were less likely to enroll in all cooperative group trials compared with whites, men, and younger patients. The proportion of African Americans enrolled in clinical trials also declined during the study period. On the basis of the Surveillance, Epidemiology, and End Results (SEER) data,4 elderly patients (age 65 years or older) represent approximately 60% of all patients with cancer but account for only 20% to 30% of the clinical trial participants.2,5 Conversely, inclusion of minority subpopulations in research has always been a complex and challenging issue. With the development of targeted therapy and immunotherapy, the number of therapeutic clinical trials has significantly grown in the past 15 years. With these new therapeutic options, the overall adverse effect profile of cancer treatment has improved, making it more tolerable for our oncology patients. At the same time, it has been increasingly recognized that it is important to collect data on subpopulations for whom knowledge gaps exist. Balanced enrollment in clinical trials offers the opportunity to understand whether variances in ethnicity, age, and sex result in substantial differences in drug efficacy and tolerability. However, it is not clear whether the enrollment of minorities and female patients has increased with the apparently increased availability of clinical trials. In this analysis, we reviewed the enrollment pattern of all completed cancer clinical trials in the seven most prevalent tumor types over the past 14 years. Our goal was to compare participation in clinical trials by racial/ethnic group and sex. We also assessed changes in
%U http://ascopubs.org/doi/full/10.1200/JOP.2017.025288