Richard M. Fairbanks School of Public Health, Indiana University-Purdue University Indianapolis, IN 46202, USA.
Cancer. 2013 Aug 15;119(16):2956-63. doi: 10.1002/cncr.28168. Epub 2013 May 14.
Inclusion of diverse groups of participants in cancer clinical trials is an important methodological and clinical issue. The quality of the science and generalizability of results depends on the inclusion of study participants who represent all populations among whom these treatment and prevention approaches will be used.
We conducted a systematic review using OVID as the primary source of reports included. Based on 304 peer-reviewed publications, diversity in the inclusion and reporting of study participants during a decade of cancer treatment and prevention trials (2001-2010) is summarized. Recommendations are made for improvements in the science and reporting of cancer clinical trials.
Of the 277 treatment trials and 27 prevention trials included in this report, more than 80% of participants were white and 59.8% were male. In the recent decade, race and sex are rarely used as selection criteria unless the trial is focused on a sex-specific cancer.
Women and racial/ethnic minorities remain severely underrepresented in cancer clinical trials, thus limiting the generalizability of cancer clinical research.
将不同群体的参与者纳入癌症临床试验是一个重要的方法学和临床问题。科学的质量和结果的普遍性取决于纳入研究参与者，这些参与者代表将使用这些治疗和预防方法的所有人群。
我们使用 OVID 作为纳入报告的主要来源进行了系统综述。基于 304 篇同行评议的出版物，总结了十年来癌症治疗和预防试验（2001-2010 年）中研究参与者纳入和报告的多样性。为改善癌症临床试验的科学和报告提出了建议。
本报告纳入的 277 项治疗试验和 27 项预防试验中，超过 80%的参与者为白人，59.8%为男性。在最近十年中，种族和性别很少被用作选择标准，除非试验专注于特定于性别的癌症。
女性和种族/少数民族在癌症临床试验中仍然严重代表性不足，从而限制了癌症临床研究的普遍性。
