Department of Psychology and Human Development, Vanderbilt University, Nashville, Tennessee, USA.
J Clin Child Adolesc Psychol. 2022 May-Jun;51(3):360-373. doi: 10.1080/15374416.2022.2062762. Epub 2022 May 12.
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.
国家心理健康研究所（NIMH）战略计划（2021 年）中概述的四个主要目标之一是开发和测试新的治疗方法和预防策略。R61/R33 赠款机制的资助机会公告（FOA）旨在通过实验治疗方法，支持对成人和儿童精神障碍的新型干预措施进行探索性临床试验的高效试点测试。本评论（a）描述了 R61/R33 赠款机制，定义了术语，并总结了系统中当前赠款的信息，（b）概述了审查标准，（c）强调了几个常见的批评。申请人和评审员经常表示关切的问题包括定义和测量目标/机制、确定剂量、选择适当的对照组、测量一致性以及确定功效。最后，讨论了与发现旨在减少和预防整个生命周期精神疾病的新型干预措施的实验治疗方法相比或作为其替代方法的干预开发的随机临床试验的替代途径。
