Effect of a US National Institutes of Health programme of clinical trials on public health and costs
Effect of a US National Institutes of Health programme of clinical trials on public health and costs
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DOI：
10.1016/s0140-6736(06)68578-4
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发表时间：
2006-04-22
期刊：
影响因子：
168.9
通讯作者：
Elkins, JS
中科院分区：
文献类型：
--
作者：
Johnston, SC;Rootenberg, JD;Elkins, JS
背景 很少有人尝试估计医学研究的公共投资回报。临床试验是测试干预措施的最后一步，其总成本和社会效益可以通过评估试验结果对医疗保健和健康的影响来估计。 方法 纳入 2000 年 1 月 1 日之前由美国国家神经疾病和中风研究所资助的所有 III 期随机试验。通过系统审查确定了有关每种研究干预措施的使用、社会成本和健康影响的相关出版物，并补充了其他公共和专有来源的数据。无论试验结果是阳性还是阴性，有关所测试疗法的使用信息都会与已发布的每次使用的成本和健康影响数据（换算为 2004 美元）相结合，以生成美国人口的 10 年预测。调查结果包括 28 项试验，总成本为 3.35 亿美元。六项试验（21%）显着改善了健康状况，四项试验（14%）为社会节省了成本。 10 年时，试验计划预计带来 47 万个质量调整生命年，总成本达 36 亿美元（包括所有试验的费用以及额外的医疗保健和其他支出）。按人均国内生产总值计算质量调整后的生命年，预计 10 年社会净效益为 152 亿美元。 95% 的置信区间不包括 10 年的净损失。对于该机构而言，临床试验的公共投资回报非常可观。尽管结果导致医疗保健支出增加，但健康收益是巨大且有价值的。
Background Few attempts have been made to estimate the public return on investment in medical research. The total costs and benefits to society of a clinical trial, the final step in testing an intervention, can be estimated by evaluating the effect of trial results on medical care and health.Methods All phase III randomised trials funded by the US National Institute of Neurological Disorders and Stroke before Jan 1, 2000, were included. Pertinent publications on use, cost to society, and health effects for each studied intervention were identified by systematic review, supplemented with data from other public and proprietary sources. Regardless of whether a trial was positive or negative, information on use of tested therapies was integrated with published per-use data on costs and health effect (converted to 2004 US$) to generate 10-year projections for the US population.Findings 28 trials with a total cost of $335 million were included. Six trials (21%) resulted in measurable improvements in health, and four (14%) resulted in cost savings to society. At 10 years, the programme of trials resulted in an estimated additional 470 000 quality-adjusted life years at a total cost of $3.6 billion (including costs of all trials and additional health-care and other expenditures). Valuing a quality-adjusted life year at per-head gross domestic product, the projected net benefit to society at 10-years was $15.2 billion. 95% CIs did not include a net loss at 10 years.Implications For this institute, the public return on investment in clinical trials has been substantial. Although results led to increases in health-care expenditures, health gains were large and valuable.