Gerth van Wijk Roy
Section of Allergology, Department of Internal Medicine, Erasmus Medical Centre, 's Gravendijkwal 230, 3015 CE Rotterdam, The Netherlands.
Allergo J Int. 2018;27(6):167-172. doi: 10.1007/s40629-018-0058-y. Epub 2018 May 24.
Allergen immunotherapy has proven to be efficacious in allergic rhinitis and asthma. However, results from randomised clinical trials may vary substantially. Clinical trials may unexpectedly fail. The purpose of this review is to discuss the possible factors that may contribute to a successful or unsuccessful study.
Descriptive review exploring the possible causes of negative outcomes in allergen immunotherapy trials.
A series of factors may lead to negative results. Among of these are underpowering of the study, low allergen content in tested extracts, insufficient allergen exposure during monitoring and recruitment of inappropriate patients. In addition, the choice of the primary endpoint may be critical.
A clinical trial aims to evaluate the efficacy of an agent. However, studies with potential effective compounds may fail because of methodical issues. Sometimes, they are the cause of discrepancies between successful phase II and unsuccessful phase III trials. To understand more about failure of studies, investigators and editors should be encouraged to publish negative trials.
变应原免疫疗法已被证明在过敏性鼻炎和哮喘中有效。然而，随机临床试验的结果可能差异很大。临床试验可能会意外失败。本综述的目的是讨论可能导致研究成功或失败的因素。
描述性综述，探讨变应原免疫疗法试验中出现阴性结果的可能原因。
一系列因素可能导致阴性结果。其中包括研究样本量不足、测试提取物中的变应原含量低、监测期间变应原暴露不足以及招募了不合适的患者。此外，主要终点的选择可能至关重要。
临床试验旨在评估一种药物的疗效。然而，具有潜在有效化合物的研究可能因方法问题而失败。有时，这些是II期试验成功与III期试验失败之间差异的原因。为了更了解研究失败的情况，应鼓励研究者和编辑发表阴性试验结果。
