title: Development of statistics as a discipline for clinical research: Past, present and future.
abstract: This article traces the history and evolution of statistics in the era of evidence based medicine, and focuses on the Indian perspective of this growth of statistics as a discipline for clinical research. Statistics will assume a more inter disciplinary form. Use of software other than SAS likely to grow further. In India, innovative statistical methods will help propel the development of biosimilars. The future is exciting with statistics being used for real world evidence, development of biosimilars, mining of adverse event data and becoming a core function in medicinal product development and lifecycle maintenance.
authors.affiliation: Chief Scientific Officer, Ph.D, Sciformix Corporation, US.
authors.forename: Chitra
authors.initials: C
authors.lastname: Lele
keywords: Biostatistics; clinical research; real world evidence; risk-based monitoring