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Clinical trials in allergen immunotherapy: current concepts and future needs

机译：过敏原免疫治疗中的临床试验：目前的概念和未来需求

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Abstract Allergen immunotherapy (AIT) is a safe, effective treatment for allergic rhinoconjunctivitis and allergic asthma. However, AIT's clinical effect is still contested—primarily due to heterogeneity in clinical trial designs, study populations, therapeutic formulations, and efficacy criteria. After discussing current concepts and unmet needs, an international panel of experts made several recommendations: (i) explore and validate definitions for (clinical) responders in AIT trials; (ii) use of well‐documented, standardized provocation tests prior to inclusion of subjects with relevant diseases in AIT trials; (iii) monitoring neo‐sensitizations and occurrence of new allergy in extended AIT trials, and exclusion of polyallergic participants; (iv) validation of allergen exposure chambers with regard to natural exposure; (v) in studies of seasonal allergies, focus on peak exposure but also consider organizing two parallel, geographically distinct but otherwise identical trials; (vi) discuss adaptive trial designs with the regulatory authorities; (vii) use e‐health and m‐health technologies to capture more information on individual exposure to allergens; (viii) initiate research on potential psychological, biochemical, immune, neural, and even genomic markers of the placebo response; (ix) identify trial designs and primary endpoints that will give children with allergies easier, faster access to AIT formulations; and (x) promote and apply standardized methods for reporting systemic and local adverse events. The latest technologies and trial designs may provide novel, ethical ways of reducing bias and heterogeneity in AIT clinical trials. There is scope for physicians, patient organizations, companies, and regulators to improve clinical trials in AIT and, ultimately, to provide patients with better treatments.
机译：摘要过敏原免疫疗法（AIT）是一种安全，有效的过敏性鼻咽炎和过敏性哮喘的治疗方法。然而，AIT的临床效果仍然是争论 - 主要是由于临床试验设计，研究人群，治疗制剂和功效标准的异质性。在讨论当前概念和未满足需求之后，国际专家委员会提出了一些建议：（i）探索和验证AIT试验中（临床）响应者的定义; （ii）在将受试者纳入AIT试验中的受试者之前使用良好记录的标准化挑衅试验; （iii）监测延长AIT试验中的新敏感性和新过敏的发生，并排除了多功能参与者; （iv）对自然暴露的过敏原曝光室的验证; （v）在季节性过敏的研究中，专注于峰值曝光，但也考虑组织两个平行，地理上截然不同但其他相同的试验; （vi）与监管机构讨论自适应试验设计; （vii）使用电子健康和m健康技术来捕获更多有关过敏原的接触的更多信息; （viii）启动安慰剂反应的潜在心理，生物化学，免疫，神经甚至甚至基因组标记的研究; （IX）识别试验设计和主要终点，使过敏患者更容易，更快地获得AIT配方; （x）促进并应用报告系统和局部不良事件的标准化方法。最新的技术和试验设计可以提供新的，在AIT临床试验中降低偏倚和异质性的道德方式。医生，患者组织，公司和监管机构有范围，以改善AIT的临床试验，并最终为患者提供更好的治疗。

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