Guest editors' introduction: what can large pragmatic clinical trials do for public mental health care?
Guest editors' introduction: what can large pragmatic clinical trials do for public mental health care?
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客座编辑介绍：大型实用性临床试验能为公众精神卫生保健做什么？
DOI：
10.1093/oxfordjournals.schbul.a006979
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发表时间：
2003
影响因子：
6.6
通讯作者：
Stroup,TScott
中科院分区：
文献类型：
--
作者：
Lieberman,JeffreyA;Stroup,TScott
身居要职的人往往需要在信息不充分的情况下做出重要决定。那些参与公共精神卫生保健的人也不例外。前景看好的新疗法往往伴随着高昂的价格标签，决策者必须利用他们掌握的任何信息来权衡收益和成本。最近，这种紧张局势变得更加尖锐，有可能达到危机的程度。随着医疗费用再次以超过通货膨胀的速度上涨，联邦和州政府面临预算短缺，医疗保险、医疗补助、退伍军人健康管理局和私人第三方支付者面临着越来越大的压力，要求他们限制支出(Abelson 2002；Freudenheim 2002；Pear 2002b，2002 c)。越来越多的人没有保险，预计投保人的选择更少，面临更高的自掏腰包支出(Strunk等人。生物医学研究技术的革命和由此产生的迅速增长的知识基础，与高额利润的前景相一致，加快了制药业的药物开发速度(Berndt 2001)。因此，每年都有越来越多的药物获得美国食品和药物管理局(FDA)的批准并投入临床使用(Berndt 2001)。抗精神病药物就是一个很好的例子。自1953年第一种抗精神病药物氯丙嗪在美国推出后，11种药物获得了FDA的批准，并在1989年投入临床使用。氯丙嗪是一类药物的原型，最初被称为抗精神病药物，但自那以来已被称为各种名称，包括典型的、常规的或第一代抗精神病药物。1989年，被认为是被称为非典型抗精神病药物的第二代抗精神病药物的原型氯氮平获得了FDA的批准。在氯氮平被引入之前的12年里，没有新药在美国被批准作为抗精神病药物，而在氯氮平之后的12年里，有6种药物目前只有5种被上市用于临床
Persons in positions of responsibility often need to make important decisions with inadequate information. Those involved in public mental health care are no exception. Promising new treatments often come with high price tags, and decision makers must use whatever information they have to weigh benefits against costs. Of late, this tension has become more acute, threatening to reach crisis proportions. With the costs for health care once again rising at a rate that exceeds inflation and Federal and State governments facing budget shortfalls, increasing pressure is being placed on Medicare, Medicaid, the Veterans Health Administration, and private third party payers to limit expenditures (Abelson 2002; Freudenheim 2002; Pear 2002b, 2002c). A growing number of people are uninsured, and the insured are expected to have fewer options and to face higher out-of-pocket expenditures (Strunk et al. 2001; Abelson 2002; Pear 2002a).The revolution in biomedical research technology and the burgeoning knowledge base that this has produced, in concert with the prospect of large profits, have accelerated the pharmaceutical industry’s rate of drug development (Berndt 2001). Consequently, an increasing number of drugs are approved by the US Food and Drug Administration (FDA) and introduced into clinical use each year (Berndt 2001). Antipsychotic drugs are a case in point. After the first antipsychotic drug chlorpromazine was introduced in the United States in 1953, 11 agents were approved by the FDA and made available for clinical use through 1989. Chlorpromazine was the prototype of a class of drugs that were initially termed neuroleptics but have since become known by a variety of names, including typical, conventional, or first generation antipsychotic drugs. In 1989, clozapine, considered the prototype of a second generation of antipsychotic drugs called atypical antipsychotic drugs, was approved by the FDA. In the 12 years prior to the introduction of clozapine, there were no new drugs approved as antipsychotics in the United States, while in the 12 years since clozapine, there have been six though only five are currently marketed for clinical use