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首页> 外文期刊>Journal of the American Academy of Child and Adolescent Psychiatry >Data safety monitoring boards and other study methodologies that address subject safety in 'high-risk' therapeutic trials in youths.
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Data safety monitoring boards and other study methodologies that address subject safety in 'high-risk' therapeutic trials in youths.

机译：数据安全监控委员会和其他研究方法论，旨在解决青少年“高风险”治疗试验中受试者的安全问题。

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摘要

The underlying proposition for any experimental/ therapeutic trial is the uncertainty that the risks of treatment will be outweighed by its benefits. For some therapeutic interventions (e.g., exercise programs, vitamin supplementation), the potential for treatment-emergent adverse events may prima facie be low or negligible, whereas for others (e.g., chemotherapy, invasive surgeries), the potential for treatment-emergent adverse events may be substantial. Because it is both scientifically and ethically necessary to determine efficacy, tolerability, and safety of medical treatments, a number of strategies have been developed to increase the probability that evidence of both effect and harm can be reasonably identified before the intervention passes into general use. One of those strategies is the randomized, placebo-controlled trial (RCT) in the pharmacotherapy of child and adolescent psychiatric disorders. In addition, a variety of structures and procedures have been developed to mitigate the risk to subjects who agree to participate in therapeutic research.
机译：任何实验/治疗试验的基本命题都是不确定性，即治疗的益处将无法抵消其益处。对于某些治疗性干预措施（例如，锻炼计划，补充维生素），可能在治疗初期出现不良事件的可能性很小或可以忽略不计，而对于其他干预措施（例如，化学疗法，侵入性手术），在治疗初期出现的不良事件的可能性可能是实质性的。由于确定医学治疗的功效，耐受性和安全性在科学和伦理上都是必须的，因此已开发出许多策略来增加在干预措施进入普遍使用之前可以合理地识别出效果和伤害的证据的可能性。这些策略之一是儿童和青少年精神疾病药物治疗的随机安慰剂对照试验（RCT）。另外，已经开发出各种结构和程序以减轻同意参加治疗研究的受试者的风险。

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