Reducing the costs of phase III cardiovascular clinical trials
Reducing the costs of phase III cardiovascular clinical trials
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DOI：
10.1016/j.ahj.2004.04.049
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发表时间：
2005-03-01
影响因子：
4.8
通讯作者：
Califf, RM
中科院分区：
文献类型：
--
作者：
Eisenstein, EL;Lemons, PW;Califf, RM
制药行业每年用于研发的费用约为264亿美元（心血管产品为41亿美元）。我们比较了制药公司在III期心血管试验中计划的资源使用和成本，并确定了节省成本的策略。方法和结果我们开发了2个病例情景（17，000例患者，开放标签急性冠状动脉综合征[ACS]试验和14;500例患者，双盲充血性心力衰竭[CHF]）试验，并调查了6名制药专家关于预期资源（例如，研究中心数量、病例报告表[CRF]页和监查访视）。使用经过验证的模型，我们根据每位专家的假设估算了成本。ACS试验平均费用为8300万美元（中位数为6700万美元;范围为5700万至1.58亿美元），CHF试验平均费用为1.42亿美元（中位数为1.35亿美元;范围为1.02亿至2.07亿美元）。两项试验的研究中心相关费用（研究中心管理和付款）均占总成本的65%以上。在敏感性分析中，总成本降低>40%，同时减少CRF页，监测访问，和网站支付金额，但保持患者和sites.Conclusions的数量与一组网站和患者，最有效的方法来降低试验成本，仍然满足试验的科学目标是减少管理的复杂性。管理参数的适度变化释放了大量资金来回答更多的研究问题。
Background The pharmaceutical industry spends similar to$26.4 billion annually for research and development ($4.1 billion in cardiovascular products). We compared pharmaceutical companies' planned resource use and costs in Phase III cardiovascular trials and identified cost-saving strategies.Methods and Results We developed 2 case scenarios (a 17,000-patient, open-label acute coronary syndromes [ACS] trial and a 1 4;500-patient, double-blind congestive heart failure [CHF]) trial and surveyed 6 pharmaceutical experts about expected resources (e.g., number of sites, case report form [CRF] pages, and monitoring visits) needed for the trials. Using a validated model, we estimated costs under each expert's assumptions. ACS trial costs averaged $83 million (median, $67 million; range, $57 to $158 million) and $142 million (median, $135 million; range, $102 to $207 million) for the CHF trial. Site-related expenses (site management and payments) were >65% of total costs for both trials. In sensitivity analyses, total costs were reduced >40% by simultaneously reducing CRF pages, monitoring visits, and site-payment amounts but maintaining the numbers of patients and sites.Conclusions With a set number of sites and patients, the most efficient way to reduce trial costs and still meet the trial's scientific objectives is to reduce management complexity. Modest changes in management parameters release significant monies to answer more research questions.