Effective Data Analysis for Nontraditional Study Designs

Dr. D.J. Tang, senior vice president of data services at Firma Clinical Research, provides insights on effective data analysis for nontraditional study designs in this article for the Association of Clinical Research Professionals

The article discusses the differences between traditional study designs (including those listed in ICH E9 from the International Council for Harmonization and other common ones) and nontraditional study designs, and then explains how biometrics teams can successfully navigate the changing approaches, including through:

  • examples of nontraditional study designs (for example, enrichment designs and event-driven designs);
  • advanced data analysis tools for unconventional data;
  • the application of digital technologies to increase flexibility while preserving integrity; and
  • future development of biostatistical methods for nontraditional designs.