Purpose

Alliances between firms are becoming more common for drug development; however, it is not clear how these alliances affect the time spent on drug development. This study analyzes the effect of firm’s alliances on the clinical development time of new drugs by clinical phase.

Methods

Datasets of the new drug development program in which the Phase 1 trials were started between 2000 and 2015 were constructed using the Evaluate Pharma’s pipeline database. The development time was calculated by measuring the number of days between the initiation dates of a development phase and the date of the subsequent phase, utilizing data from the database. A multiple regression analysis was performed to determine the effect of firm’s alliances on the new drug development time at each stage of development, after controlling for the origin of substances, therapeutic indications, drug designation, and firm size.

Results

A firm’s alliances significantly increased the development times of clinical Phases 1, 2, and 3 by 549.3 days, 617.3 days, and 232.0 days, respectively. However, there was no statistically significant effect on the development time of the approval stage.

Conclusion

As a firm’s alliances significantly increases the drug development time in the early clinical phases, companies developing new drugs through alliances in the early clinical development stages need to make more efforts to reduce the development time.

中文翻译：

---

公司联盟是否会增加新药开发时间？临床开发时间的多元回归分析

目的

公司之间的联盟在药物开发中变得越来越普遍；然而，尚不清楚这些联盟如何影响药物开发的时间。本研究按临床阶段分析了企业联盟对新药临床开发时间的影响。

方法

使用 Evaluate Pharma 的管道数据库构建了 2000 年至 2015 年间开始的第一阶段试验的新药开发计划的数据集。开发时间是通过利用数据库中的数据测量开发阶段的开始日期和后续阶段的日期之间的天数来计算的。在控制了物质来源、治疗适应症、药物名称和公司规模后，进行了多元回归分析，以确定公司联盟对每个开发阶段的新药开发时间的影响。

结果

公司联盟将临床 1、2 和 3 期的开发时间分别显着增加了 549.3 天、617.3 天和 232.0 天。然而，对审批阶段的开发时间没有统计上显着的影响。

结论

由于企业联盟大大增加了早期临床阶段的药物开发时间，因此在临床早期阶段通过联盟开发新药的企业需要付出更多努力来缩短开发时间。