关于药物开发延迟一天的成本的新估算。

IF 2 4区 医学 Q4 MEDICAL INFORMATICS Therapeutic innovation & regulatory science Pub Date : 2024-09-01 Epub Date: 2024-05-21 DOI:10.1007/s43441-024-00667-w
Zachary P Smith, Joseph A DiMasi, Kenneth A Getz
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引用次数: 0

摘要

临床研究业内人士和观察家经常引用的两个数字--错过一天产生处方药销售额的成本和错过一天进行临床试验的成本--已经过时,而且是基于传闻证据。2023 年底,塔夫茨药物开发研究中心开展了实证研究,以收集更准确、更细化的估算数据,并检验日平均销售额是否随时间推移而发生变化。研究人员从商业可用数据集和专有数据集中提取并分析了自 2000 年以来上市的 645 种药物和 409 项临床试验预算。结果表明,一天的处方药或生物制剂销售损失约等于 50 万美元,其中传染病、血液病、心血管病和胃肠道疾病的处方药日销售额最高。结果还显示,处方药和生物制剂的日均销售额每年都会减少约 8 万至 10 万美元。在 II 期和 III 期临床试验中,估计每天进行临床试验的直接成本约为 40,000 美元,其中呼吸系统、风湿病和皮肤病领域每天的相对直接成本最高。
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New Estimates on the Cost of a Delay Day in Drug Development.

Two frequently cited figures by clinical research insiders and observers - the cost of missing a day to generate prescription drug sales and the cost of a day to conduct a clinical trial - are outdated and based on anecdotal evidence. In late 2023, the Tufts Center for the Study of Drug Development conducted empirical research to gather more accurate and granular estimates and to test whether average sales per day have changed over time. 645 drugs launched since 2000, and 409 clinical trial budgets were drawn from commercially available and proprietary data sets and analyzed. The results indicate that a single day equals approximately $500,000 in lost prescription drug or biologic sales, with daily prescription sales for infectious, hematologic, cardiovascular, and gastrointestinal diseases among the highest. The results also show that each year, the average sales per day of prescription drugs and biologics has decreased by approximately $80,000-$100,000. The estimated direct daily cost to conduct a clinical trial is approximately $40,000 per day for phase II and III clinical trials, with those in respiratory, rheumatology, and dermatology having the highest relative daily direct costs.

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来源期刊
Therapeutic innovation & regulatory science
Therapeutic innovation & regulatory science MEDICAL INFORMATICS-PHARMACOLOGY & PHARMACY
CiteScore
3.40
自引率
13.30%
发文量
127
期刊介绍: Therapeutic Innovation & Regulatory Science (TIRS) is the official scientific journal of DIA that strives to advance medical product discovery, development, regulation, and use through the publication of peer-reviewed original and review articles, commentaries, and letters to the editor across the spectrum of converting biomedical science into practical solutions to advance human health. The focus areas of the journal are as follows: Biostatistics Clinical Trials Product Development and Innovation Global Perspectives Policy Regulatory Science Product Safety Special Populations
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