Pharmaceutical Organizational Size and Phase 3 Clinical Trial Completion Times

Area of Science:

• Pharmaceutical industry
• Clinical trial management
• Research and Development (R&D)

Background:

• Pharmaceutical industry mergers aim for scale efficiencies and improved commercial and R&D performance.
• Increasingly large pharmaceutical R&D organizations are emerging due to mergers.

Purpose of the Study:

• To investigate the relationship between organizational size and phase 3 clinical trial completion times.
• To identify key factors influencing clinical trial duration in the pharmaceutical sector.

Main Methods:

• Analysis of commercially sponsored phase 3 clinical trials data from ClinicalTrials.gov (2008-2013).
• Utilized bidirectional stepwise Akaike information criterion for statistical model selection.

Main Results:

• Study therapeutic area significantly impacts completion times.
• Protocol design and clinical study execution plans critically influence study duration.
• Organizational experience in a specific therapeutic area, not just size, demonstrably impacts completion times.

Conclusions:

• While larger pharmaceutical companies may achieve scale benefits, increased size does not correlate with faster phase 3 study completion.
• Factors like therapeutic area and specialized organizational experience are more influential in determining clinical trial timelines.