Smith Zachary P, DiMasi Joseph A, Getz Kenneth A
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA.
Ther Innov Regul Sci. 2024 Sep;58(5):855-862. doi: 10.1007/s43441-024-00667-w. Epub 2024 May 21.
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- the cost of missing a day to generate prescription drug sales and the cost of a day to conduct a clinical trial - are outdated and based on anecdotal evidence.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.
临床研究业内人士和观察家经常引用的两个数据——错失一天产生处方药销售额的成本以及进行一天临床试验的成本——已经过时,且基于传闻证据。2023年末,塔夫茨药物开发研究中心开展了实证研究,以获取更准确、更详细的估计,并检验日均销售额是否随时间变化。从商业可用的专有数据集中提取并分析了2000年以来推出的645种药物以及409个临床试验预算。结果表明,一天的损失相当于处方药或生物制品销售额损失约50万美元,其中传染病、血液学、心血管疾病和胃肠道疾病的日处方销售额最高。结果还显示,每年处方药和生物制品的日均销售额大约下降了8万至10万美元。II期和III期临床试验进行一天的估计直接成本约为每天4万美元,其中呼吸科、风湿病科和皮肤科的相对每日直接成本最高。