Health Outcomes and Behavior Program, Moffitt Cancer Center, Tampa, Florida 33612-9416, USA.
J Urol. 2010 Sep;184(3):901-6. doi: 10.1016/j.juro.2010.04.076.
On June 7, 2000 President Clinton issued an executive memorandum directing Medicare payment for routine patient care in qualifying clinical trials. We estimated the proportion of older patients with prostate cancer who were examined as part of a qualifying clinical trial, and the association between participation and patient characteristics.
We performed an observational study using the Surveillance, Epidemiology and End Results Medicare database to determine participation in qualifying clinical trials in a sample of 37,216 men 66 years old or older who were enrolled in Medicare and diagnosed with prostate cancer between September 2000 and December 2002.
Within 3 years of diagnosis 211 men (0.567%) received routine patient care in a qualifying clinical trial. These participants were more likely to be younger than 70 years (OR 1.687, 95% CI 1.27-2.24) and less likely to be less educated and reside in low income, metropolitan neighborhoods. White men were more likely to participate in clinical trials than nonwhite men but this association was not statistically significant (OR 1.426, CI 0.97-2.09). Participation varied significantly by registry site (0% to 1.2%) but not by tumor grade or stage, or prostate specific antigen status.
Few older patients with prostate cancer participated in qualifying trials between 2000 and 2002. Those who participated were not representative of the general population of older patients with prostate cancer. Greater efforts are required to expand trial enrollment and decrease disparities in research participation.
2000 年 6 月 7 日，克林顿总统发布行政备忘录，指示医疗保险为符合条件的临床试验中的常规患者护理提供支付。我们估计了参加合格临床试验的老年前列腺癌患者的比例，以及参与度与患者特征之间的关系。
我们使用监测、流行病学和最终结果医疗保险数据库进行了一项观察性研究，以确定在 2000 年 9 月至 2002 年 12 月期间参加医疗保险并被诊断患有前列腺癌的 37216 名 66 岁或以上的男性样本中，有多少人参加了合格的临床试验。
在诊断后的 3 年内，有 211 名男性（0.567%）在合格的临床试验中接受了常规患者护理。这些参与者更年轻，年龄在 70 岁以下（OR 1.687，95%CI 1.27-2.24），受教育程度较低，居住在低收入的大都市区。白人男性比非白人男性更有可能参加临床试验，但这种关联没有统计学意义（OR 1.426，CI 0.97-2.09）。参与度因登记处地点而异（0%至 1.2%），但与肿瘤分级或分期或前列腺特异性抗原状态无关。
2000 年至 2002 年间，很少有老年前列腺癌患者参加合格试验。参与试验的患者不能代表一般的老年前列腺癌患者人群。需要做出更大的努力来扩大试验招募并减少研究参与的差异。
