Division of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences (UIPS), Faculty of Science, Utrecht, The Netherlands.
Scand J Rheumatol. 2011 May;40(3):183-91. doi: 10.3109/03009742.2010.509102. Epub 2010 Sep 21.
To investigate the main aims of the post-approval randomized controlled trials (RCTs) on etanercept and the extent to which they were designed to gain more comparative information.
A search of the literature (Medline, Embase), trial registries (Clinical Trials.gov, Controlled Trials.com), and market authorization reports from the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) was carried out to identify all RCTs. A comparison of trial data identified unpublished trials and multiple publications relating to the same study. All RCTs completed and/or published after initial market approval was regarded as post-approval.
Up until 2008, we found 84 post-approval trials, 11 (13%) trials on approved extensions of indication, another 30 (36%) trials on the approved indications, and 43 (51%) trials on indications not (yet) approved. Nearly half of the studies on indications not yet approved were initiated and funded by independent sponsors. After the initial approval of etanercept, six head-to-head trials were conducted on the approved indications. Overall, the main objectives of post-approval trials with etanercept were found to confirm efficacy and safety in new indications, and to gather additional information for optimal use on the approved indications.
Post-approval RCTs on etanercept focus more on studies searching for new indications than on deepening knowledge about use. Ten years after the market entry of etanercept, one of the reasonable demands of clinical practice, for more comparative information, still remains unanswered.
调查依那西普的上市后随机对照试验（RCT）的主要目的，以及它们在多大程度上旨在获得更多的比较信息。
对文献（Medline、Embase）、试验注册处（ClinicalTrials.gov、ControlledTrials.com）以及食品药品监督管理局（FDA）和欧洲药品管理局（EMEA）的市场授权报告进行了检索，以确定所有 RCT。对试验数据进行比较，确定了未发表的试验和与同一研究相关的多个出版物。所有完成并/或在初始市场批准后发布的 RCT 都被视为上市后试验。
截至 2008 年，我们发现了 84 项上市后试验，其中 11 项（13%）是关于批准的适应症扩展的试验，另外 30 项（36%）是关于批准的适应症的试验，43 项（51%）是关于未批准（尚未）批准的适应症的试验。近一半的关于未批准适应症的研究是由独立赞助商发起和资助的。在依那西普最初获得批准后，对批准的适应症进行了六次头对头试验。总体而言，依那西普上市后试验的主要目的是在新适应症中确认疗效和安全性，并收集关于批准适应症的最佳使用的额外信息。
依那西普的上市后 RCT 更多地关注于寻找新适应症的研究，而不是加深对使用的了解。依那西普上市十年后，临床实践的一个合理要求，即更多的比较信息，仍然没有得到满足。
