Getz Kenneth, Faden Laura
Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 02111, USA.
Am J Ther. 2008 Jan-Feb;15(1):3-11. doi: 10.1097/MJT.0b013e31815fa75a.
Evidence shows that minority patients are underrepresented in clinical trials. The development of new drugs and treatments, however, requires that clinical research studies include representative participants, particularly in light of evidence indicating that minority populations sometimes respond differently to prescription medications. Racial disparities among clinical investigators are often cited as a major reason why minority patients are underrepresented in clinical trials. However, there is little to no empirical data to support or refute the prevalence of disparities among clinical investigators. The Tufts Center conducted two online surveys of 1376 physicians. The first survey (N = 859 respondents; 31% response rate) assessed the overall incidence of minority physician involvement in clinical research. The second survey (N = 768 respondents; 20% response rate) assessed the demographics, experience, and infrastructure of minority physicians who have participated in clinical research as a principal investigator or subinvestigator. The results of this study indicate that significant racial disparities exist among clinical investigators. The results also support assertions that physician race influences race of the clinical trial volunteer. The incidence of participation in clinical research among minority physicians is well below that observed among white physicians, more so with regard to U.S. Food & Drug Administration-regulated clinical trials funded by industry. Minority investigators tend to conduct and initiate fewer clinical trials annually. Yet minority and white physician interest in participating in clinical research is similarly high. Minority investigators tend be younger, with more limited clinical research infrastructure and support than their white counterparts. New strategies, policies, incentives, and reforms are needed to address racial disparities among clinical investigators. In addition, disparities among both volunteers and investigators need to be tracked more closely and methodically to monitor and assess the impact of newly implemented programs and reforms.
有证据表明，少数族裔患者在临床试验中的代表性不足。然而，新药和治疗方法的研发需要临床研究纳入具有代表性的参与者，特别是鉴于有证据表明少数族裔人群有时对处方药的反应有所不同。临床研究人员之间的种族差异常被认为是少数族裔患者在临床试验中代表性不足的主要原因。然而，几乎没有实证数据来支持或反驳临床研究人员中存在差异的普遍情况。塔夫茨中心对1376名医生进行了两项在线调查。第一项调查（859名受访者；31%的回复率）评估了少数族裔医生参与临床研究的总体发生率。第二项调查（768名受访者；20%的回复率）评估了作为主要研究者或副研究者参与临床研究的少数族裔医生的人口统计学特征、经验和基础设施。这项研究的结果表明，临床研究人员之间存在显著种族差异。结果还支持了医生种族会影响临床试验志愿者种族的说法。少数族裔医生参与临床研究的发生率远低于白人医生，在由行业资助的美国食品药品监督管理局监管的临床试验中更是如此。少数族裔研究人员每年开展和发起的临床试验往往较少。然而，少数族裔和白人医生参与临床研究的兴趣同样高。少数族裔研究人员往往更年轻，与白人同行相比，他们的临床研究基础设施和支持更为有限。需要新的策略、政策、激励措施和改革来解决临床研究人员之间的种族差异。此外，需要更密切、更系统地跟踪志愿者和研究人员之间的差异，以监测和评估新实施的项目和改革的影响。
