Does Firm's Alliances Increase New Drug Development Time? A Multiple Regression Analysis of Clinical Development Time.

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. [ABSTRACT FROM AUTHOR]