Yazici Yusuf
New York University School of Medicine, NY, USA.
Bull NYU Hosp Jt Dis. 2008;66(2):143-5.
Reporting of adverse events (AEs) in randomized clinical trials (RCTs) is often lacking and with limited application in the real world, as RCTs are of short duration, include small numbers of patients, and are selective for subjects lacking in comorbid conditions. It is not surprising that new and unexpected safety concerns emerge with any new drug after it has been launched and used by many more patients. Part of the problem is inherent to the way safety data are reported in RCTs. This article focuses on some of the shortcomings of AE reporting in RCTs, especially those involving tumor necrosis factor (TNF) inhibitors. Discussion focuses on reporting of "time-to-event" issues, use of standardized incidence ratios for comparison to normal population or disease controls, use of "patient-years" when reporting AEs, and the problem of adequate sample size and power calculations that are lacking in safety outcome data trials.
随机临床试验（RCT）中不良事件（AE）的报告往往缺失，且在现实世界中的应用有限，因为RCT持续时间短，纳入患者数量少，且对无合并症的受试者具有选择性。因此，任何新药在上市并被更多患者使用后出现新的和意想不到的安全问题也就不足为奇了。部分问题源于RCT中安全数据的报告方式。本文重点关注RCT中AE报告的一些缺点，尤其是那些涉及肿瘤坏死因子（TNF）抑制剂的缺点。讨论集中在“事件发生时间”问题的报告、与正常人群或疾病对照进行比较时标准化发病率比的使用、报告AE时“患者年”的使用，以及安全结局数据试验中缺乏足够样本量和功效计算的问题。
