Practical clinical trials for schizophrenia.
Practical clinical trials for schizophrenia.
复制标题
精神分裂症的实用临床试验。
DOI：
10.1017/s1121189x00006370
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发表时间：
2005
期刊：
影响因子：
--
通讯作者：
Stroup,Scott
中科院分区：
文献类型：
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作者：
Stroup,Scott
为了有效地满足监管机构的要求，疗效试验建立了药物的短期安全性以及在理想情况下减轻目标症状的能力。这些试验几乎没有提供关于干预措施在现实世界中如何发挥作用的信息，在现实世界中，临床医生在提出建议时要进行相当大的判断，患者对所提供的治疗方法做出选择，以及成本、便利性和舒适度有重大影响的地方。其结果是所谓的疗效差距，即在典型情况下，治疗效果不如在疗效试验的理想情况下（医学研究所，1985年）。此外，疗效试验不能回答患者、临床医生和政策制定者面临的许多重要问题。由于疗效试验通常将新药与安慰剂或单一活性药物进行比较，因此它们通常不能提供与最常用治疗方法相比的治疗效果的直接信息。此外，他们不关心许多重要的问题
In order to meet the requirements of regulatory agencies efficiently, efficacy trials establish the short-term safety of a drug and its ability to lessen target symptoms under ideal circumstances. These trials provide little information about how interventions will work in the real world, where clinicians exercise considerable judgment in making recommendations, patients make choices about the treatments they are offered, and where costs, convenience, and comfort have significant influence. A result is the so-called efficacy-effectiveness gap in which treatments are found less beneficial in typical circumstances rather than in the ideal circumstances of efficacy trials (Institute of Medicine, 1985). In addition, efficacy trials do not answer many important questions faced by patients, clinicians, and policy makers. Because efficacy trials usually compare new drugs to placebo or a single active drug, they often do not provide direct information regarding a treatment's efficacy compared to the most commonly used treatments. Further, they are not concerned with many important out-