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Related Experiment Videos

Emerging and recurrent issues in drug development.

C Anello1

  • 1Office of Epidemiology and Biostatistics, Center for Drug Evaluation & Research (CDER), FDA, 5600 Fishers Lane, Parklawn Building, Room 15B33, HFD 700, Rockville, Maryland 20857, USA.

Statistics in Medicine
|September 4, 1999
PubMed
Summary
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This review covers emerging and recurring challenges in drug development, focusing on regulatory changes, internationalization, and advanced statistical methods for clinical trials. Statisticians play a key role in addressing these issues for public health improvement.

Area of Science:

  • Pharmaceutical Science
  • Biostatistics
  • Regulatory Science

Background:

  • The drug development process faces evolving challenges impacting regulatory approvals and global market access.
  • Advancements in technology and statistical methodologies are crucial for efficient and reliable drug development.
  • Established statistical approaches require re-evaluation in light of new complexities in clinical trials.

Purpose of the Study:

  • To review emerging and recurrent issues in the drug development process.
  • To highlight the role of statistical methods in addressing these challenges.
  • To emphasize the contribution of statisticians to public health.

Main Methods:

  • Literature review of emerging and recurrent issues in drug development.

Related Experiment Videos

  • Analysis of changes in the FDA regulatory environment.
  • Examination of internationalization trends and technological advancements.
  • Discussion of statistical methodologies for clinical trial design and analysis.

    • Main Results:

    • Emerging issues include regulatory shifts, globalization, technological integration, and meta-analysis adoption.
    • Recurrent issues involve subgroup analysis, alternatives to intention-to-treat, multiplicity adjustments, and data integrity.
    • These challenges necessitate advanced statistical expertise and international collaboration.

    Conclusions:

    • The drug development landscape presents ongoing statistical challenges.
    • Statisticians' diverse perspectives are vital for advancing drug development and public health.
    • Continuous innovation in statistical methods is essential for navigating the complexities of modern drug development.