Abstract

SAFTEY DATA GENERATION: A REVIEW

Sagar A. Daitkar*, Ashwini Andhale, Santosh Waghmare and Hemant Kamble

Abstract

The efficacy and safety of medicinal products should be demonstrated by clinical trials which follow the guidance in 'Good Clinical Practice: Consolidated Guideline' (ICH E6) adopted by the ICH, 1 May 1996. The role of statistics in clinical trial design and analysis is acknowledged as essential in that ICH guideline. The proliferation of statistical research in the area of clinical trials coupled with the critical role of clinical research in the drug approval process and health care in general necessitate a succinct document on statistical issues related to clinical trials. This guidance is written primarily as an attempt to harmonise the principles of statistical methodology applied to clinical trials for marketing applications. All clinical trials should have a safety component as a primary or secondary objective. In early Phase I and Phase II trials, safety and tolerability are often a primary objective and the main reason for conducting the study. In later Phase II and Phase III trials the primary objective is usually efficacy, but safety and tolerability must also be included as a secondary objective.

Keywords: Clinical trials, Good Clinical Practice, ICH guideline, Consolidated Guideline.