Biostatistical Methodologies in Clinical Trials: An Overview of Recent Developments and Pitfalls

Abstract

Biostatistical analysis has emerged as one of the most crucial applications for clinical trial systems. The relevance of statistical analysis in clinical trials cannot be overstated in the advancement of novel pharmaceuticals and therapeutics. Data volumes, including effectiveness and safety summaries, are produced throughout the process of developing and approving novel medicines. Data standards developed by the Clinical Data Interchange Standards Consortium (CDISC) are well-established, widely accepted, and widely utilized by the pharmaceutical sector for submissions to regulatory bodies.