背景:研究表明,在临床试验中,女性和黑人的代表性不足,他们的招募现在是联邦授权的。然而,对老年患者的参与水平知之甚少。我们确定了65岁或以上患者在癌症治疗试验中的入选率。
方法:我们根据性别分析了1993年至1996年在164个西南肿瘤组治疗试验中连续招募的16,396名患者的数据,种族(黑色或白色),年龄在65岁以下或65岁以上。将这些比率与癌症患者普通人群中的相应比率进行比较,源自1990年美国人口普查和国家癌症研究所的监测,流行病学,和1992年至1994年期间的最终结果计划。分析中包括15种类型的癌症。
结果:参加西南肿瘤学组试验的女性和黑人的总体比例与美国癌症患者人群中的估计比例相似或相同(女性,41%和43%;黑人,10%和10%,分别)。相比之下,65岁或以上的患者总体代表性不足(25%与63%,P<0.001),并且在涉及除淋巴瘤以外的所有15种癌症的试验中。在乳腺癌治疗试验中,代表性不足尤其显著(9%与49%,P<0.001)。当分析70岁或以上患者的数据时,结果相似,当15项排除老年患者的试验从分析中删除时,以及何时将基于社区的入学与学术中心的入学分开分析。
结论:在癌症治疗研究中,65岁或65岁以上的患者的代表性严重不足。应该澄清原因,以及为纠正这种代表性不足而采取的政策。
BACKGROUND: Studies have documented the underrepresentation of women and blacks in clinical trials, and their recruitment is now federally mandated. However, little is known about the level of participation of elderly patients. We determined the rates of enrollment of patients 65 years of age or older in trials of treatment for cancer.
METHODS: We analyzed data on 16,396 patients consecutively enrolled in 164 Southwest Oncology Group treatment trials between 1993 and 1996 according to sex, race (black or white), and age under 65 years or 65 or older. These rates were compared with the corresponding rates in the general population of patients with cancer, derived from the 1990 U.S. Census and from the National Cancer Institute\'s Surveillance, Epidemiology, and End Results Program for the period from 1992 through 1994. Fifteen types of cancer were included in the analysis.
RESULTS: The overall proportions of women and blacks enrolled in Southwest Oncology Group trials were similar to or the same as the estimated proportions in the U.S. population of patients with cancer (women, 41 percent and 43 percent; blacks, 10 percent and 10 percent, respectively). In contrast, patients 65 years of age or older were underrepresented overall (25 percent vs. 63 percent, P<0.001) and in trials involving all 15 types of cancer except lymphoma. The underrepresentation was particularly notable in trials of treatment for breast cancer (9 percent vs. 49 percent, P<0.001). The findings were similar when data on patients who were 70 years of age or older were analyzed, when 15 trials that excluded older patients were eliminated from the analysis, and when community-based enrollment was analyzed separately from enrollment at academic centers.
CONCLUSIONS: There is substantial underrepresentation of patients 65 years of age or older in studies of treatment for cancer. The reasons should be clarified, and policies adopted to correct this underrepresentation.