ABSTRACT

One of the four major goals outlined in the National Institute of Mental Health (NIMH) strategic plan (2021) is to develop and test new treatments and prevention strategies. The aim of the Funding Opportunity Announcement (FOA) for the R61/R33 grant mechanism has been to support the efficient pilot testing of exploratory clinical trials of novel interventions for mental disorders in adults and children through an experimental therapeutics approach. The present commentary (a) describes the R61/R33 grant mechanism, defines terms, and summarizes information about current grants in the system, (b) outlines the review criteria, and (c) highlights several common critiques. Frequent concerns expressed by applicants as well as reviewers include defining and measuring the target/mechanism, establishing dose, selecting an appropriate control group, measuring fidelity, and determining power. Finally, alternative pathways for conducting randomized clinical trials for intervention development are discussed in contrast to or in addition to the experimental therapeutics approach for discovering novel interventions aimed at reducing and preventing mental illness across the lifespan.

 抽象的

美国国家心理健康研究所 (NIMH) 战略计划（2021 年）概述的四个主要目标之一是开发和测试新的治疗和预防策略。 R61/R33 资助机制的资助机会公告 (FOA) 的目的是支持通过实验性治疗方法对成人和儿童精神障碍新型干预措施的探索性临床试验进行有效的试点测试。本评论 (a) 描述了 R61/R33 拨款机制，定义了术语，并总结了有关系统中当前拨款的信息，(b) 概述了审查标准，(c) 强调了一些常见的批评。申请人和审稿人经常表达的担忧包括定义和测量目标/机制、确定剂量、选择适当的对照组、测量保真度和确定功效。最后，讨论了进行干预开发随机临床试验的替代途径，与实验治疗方法形成对比或补充，以发现旨在减少和预防整个生命周期精神疾病的新干预措施。