Mosenifar Zab
Department of Medicine, Division of Pulmonary and Critical Care Medicine, Cedars-Sinai Medical Center, and David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA 90049, USA.
Proc Am Thorac Soc. 2007 May;4(2):185-7; discussion 187-8. doi: 10.1513/pats.200701-009GC.
Inclusion of underrepresented groups in clinical trials is important for several reasons. Age, sex, race, genetic factors, concomitant use of other medications, and comorbid conditions all may play pivotal roles in response to a drug or intervention. Despite the legislation for broader inclusion of underrepresented groups in clinical trials (via the National Institutes of Health [NIH] Revitalization Act of 1993), underrepresentation of particular populations, particularly minorities, continues to be a problem. Studies of predictors of clinical trial enrollment suggest that most people participate in clinical research to find relief from a disease, not for financial remuneration. Yet, men and whites are more likely to enroll in studies and some data indicate that certain patient populations are preferentially (albeit sometimes inadvertently) chosen for study enrollment. This tendency toward inclusion stems from human nature-the natural tendency for an investigator to relate to a particular investigative topic due to a special connection based on a cultural, socioeconomic, age, ethnicity, or gender level. This article reviews the most common population issues for clinical studies: age, gender, race, socioeconomic status, comorbidities, and disease severity, with examples of each from published studies. Recommendations are also offered to overcome these barriers.
将代表性不足的群体纳入临床试验很重要，原因有几个。年龄、性别、种族、遗传因素、其他药物的同时使用以及合并症在对药物或干预措施的反应中都可能起关键作用。尽管有立法要求在临床试验中更广泛地纳入代表性不足的群体（通过1993年的美国国立卫生研究院[NIH]振兴法案），但特定人群，尤其是少数群体的代表性不足仍然是一个问题。对临床试验入组预测因素的研究表明，大多数人参与临床研究是为了缓解疾病，而非为了经济报酬。然而，男性和白人更有可能参与研究，一些数据表明某些患者群体被优先（尽管有时是无意地）选为研究对象。这种纳入倾向源于人性——由于基于文化、社会经济、年龄、种族或性别层面的特殊联系，研究者自然倾向于与特定的研究主题产生关联。本文回顾了临床研究中最常见的人群问题：年龄、性别、种族、社会经济地位、合并症和疾病严重程度，并列举了已发表研究中的相关示例。还提出了克服这些障碍的建议。
