Kasai T, Ohe Y, Nishio K, Kunitoh H, Tamura T, Sekine I, Kubota K, Yamamoto N, Nakamura Y, Shinkai T, Kodama T, Saijo N
Division of Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Jpn J Clin Oncol. 1998 Mar;28(3):214-21. doi: 10.1093/jjco/28.3.214.
It is important to minimize the incidence of ineligible cases to improve the quality of clinical trials. To determine factors which may influence the incidence of ineligible cases, the incidence of and reasons for ineligibility in clinical trials were retrospectively analyzed.
We retrospectively examined the incidence of and reasons for ineligibility for inclusion in eight clinical trials conducted by the Lung Cancer Chemotherapy Study Group of the Japan Clinical Oncology Group and four trials financed by trust funds from a pharmaceutical company.
In these 12 clinical studies, the incidence of ineligibility was 4.2% (32/762) (range 0-10.6%). Specific factors that might influence the incidence of ineligible cases were then analyzed. There was a significant difference in the incidence of ineligibility between the methods of registration (P < 0.05). The incidences using a central registration and without using a central registration system were 2.8% (9/322) and 5.2% (23/440) respectively. We also analyzed ineligible cases in clinical studies published in the Journal of Clinical Oncology. In clinical studies published in the Journal of Clinical Oncology recently and 10 years ago, the incidences of ineligible cases were 5.0% (942/18 878) and 4.1% (206/4995) respectively. In clinical studies on lung cancer published in the Journal of Clinical Oncology from 1984 to 1995, the incidence of ineligible cases was 4.7% (900/19,116). There was no significant difference in the incidence of ineligible cases between our 12 studies and the Journal of Clinical Oncology clinical studies by the chi 2 test (P > 0.05).
We conclude that the incidence of ineligible cases in our studies is similar to that in clinical trials published in the Journal of Clinical Oncology. Central registration systems are useful for checking for ineligibility, and to increase the quality of clinical trials.
尽量减少不符合入选标准病例的发生率对于提高临床试验质量至关重要。为确定可能影响不符合入选标准病例发生率的因素，我们对临床试验中不符合入选标准的发生率及原因进行了回顾性分析。
我们回顾性研究了日本临床肿瘤学会肺癌化疗研究组开展的八项临床试验以及一家制药公司信托基金资助的四项试验中不符合入选标准的发生率及原因。
在这12项临床研究中，不符合入选标准的发生率为4.2%（32/762）（范围为0 - 10.6%）。随后分析了可能影响不符合入选标准病例发生率的具体因素。登记方法之间的不符合入选标准发生率存在显著差异（P < 0.05）。采用集中登记和未采用集中登记系统的发生率分别为2.8%（9/322）和5.2%（23/440）。我们还分析了发表在《临床肿瘤学杂志》上的临床研究中的不符合入选标准病例。在最近以及10年前发表于《临床肿瘤学杂志》的临床研究中，不符合入选标准病例的发生率分别为5.0%（942/18878）和4.1%（206/4995）。在1984年至1995年发表于《临床肿瘤学杂志》的肺癌临床研究中，不符合入选标准病例的发生率为4.7%（900/19116）。通过卡方检验，我们的12项研究与《临床肿瘤学杂志》临床研究之间的不符合入选标准病例发生率无显著差异（P > 0.05）。
我们得出结论，我们研究中不符合入选标准病例的发生率与发表在《临床肿瘤学杂志》上的临床试验相似。集中登记系统有助于检查不符合入选标准的情况，并提高临床试验质量。
