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Correlates of time to approval and other clinical development periods

Christopher D Breder1, Margaret VanHeusen2, Lin-Chau Chang3

  • 1Advanced Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC; Center for Drug Safety and Effectiveness, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.

Drug Discovery Today
|June 7, 2019
PubMed

Insights

This study analyzed 825 New Drug Applications (NDAs) to understand drug development timelines. Key factors influencing the duration of clinical and review phases were identified to aid pharmaceutical planning.

Area of Science:

  • Pharmaceutical Science
  • Drug Development
  • Regulatory Science

Background:

  • The drug development cycle traditionally includes clinical and review phases, with clinical trials being a key component.
  • Systematic investigation into factors influencing the duration of these development intervals is lacking.
  • Understanding these timelines is crucial for efficient pharmaceutical development.

Purpose of the Study:

  • To systematically investigate factors affecting the duration of drug development intervals.
  • To characterize the typical duration of clinical and review phases for New Drug Applications (NDAs).
  • To provide data-driven insights for pharmaceutical development planning.

Main Methods:

  • Analysis of a large population (N=825) of New Drug Applications (NDAs).
  • Data collected from NDAs approved between 2008 and 2017.
  • Statistical analysis to identify factors associated with development interval durations.

Main Results:

  • Characterization of typical durations for drug development intervals.
  • Identification of specific factors that influence the length of these intervals.
  • Quantitative insights into the drug development process.

Conclusions:

  • The study provides a systematic analysis of drug development timelines.
  • Identified factors can inform data-driven planning in pharmaceutical development.
  • Insights gained can help optimize the efficiency of bringing new drugs to market.

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