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Making what's advanced today routine tomorrow.

Stephen J Ruberg1

  • 1a Lilly Corporate Center, Global Statistical Sciences , Eli Lilly & Company , Indianapolis , Indiana , USA.

Journal of Biopharmaceutical Statistics
|September 24, 2015
PubMed
Summary

Statistical principles have transformed clinical drug development over 70 years, improving patient lives. Future statistical methodologies offer exciting opportunities for the pharmaceutical industry and regulatory science.

Keywords:
Adaptive designsICH-E9adequate and well-controlled trialsanalytics strategybayesian statisticsinterim analysismultiplicitynoninferiorityrandomizationsubgroup identification

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Area of Science:

  • Biostatistics
  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • The evolution of statistical principles has significantly impacted clinical drug development.
  • Over seven decades, statistical methodologies have reshaped the pharmaceutical industry and regulatory agencies.
  • Statistical thinking is crucial for effective drug development and decision-making.

Purpose of the Study:

  • To recount significant historical highlights in the journey of statistical principles in drug development.
  • To explore future opportunities for statistical science and its profession.
  • To emphasize the impact of statistics on improving patient lives globally.

Main Methods:

  • Historical review of statistical methodologies in clinical drug development.
  • Analysis of the impact of statistical principles on the pharmaceutical industry and regulatory bodies.
  • Exploration of emerging trends and future directions in biostatistics.

Main Results:

  • Statistical principles have demonstrably improved the clinical drug development process.
  • The pharmaceutical industry and regulatory agencies have been reshaped by statistical advancements.
  • Countless patient lives have been improved through the application of statistical science.

Conclusions:

  • The historical progression of statistical principles underscores its vital role in modern medicine.
  • Continued innovation in statistical methodologies promises further advancements in drug development.
  • The science and profession of statistics are poised for significant future growth and impact.