The “Dynamic” Integrated Database for Pre-Marketing Risk Assessment – A Paradigm Shift

Michael J Klepper

doi:10.3389/fphar.2011.00085

Abstract

The “Dynamic” Integrated Database for Pre-Marketing Risk Assessment – A Paradigm Shift

Highlights

Determining risk during this period is inherently challenging due to limited exposure to an investigational drug
This means that based on the “Rule of 3,” if 1500 patients were given an investigational drug and an adverse reaction, for example hepatotoxicity, was not seen, one can be 95% confident that the true incidence of hepatotoxicity is less than 0.2% (1500/3 = 500; 1/500 = 0.2%; Rosner, 1995; US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, 2009)
There are many steps required to take the safety data collected from a clinical study site, i.e., raw data, and convert it into data that allows aggregate analyses, i.e., analyses of data from groups of patients, so changes from baseline values and comparisons of these changes from baseline can be compared between treatment groups in order to identify any differences

Summary

Introduction

Determining risk during this period is inherently challenging due to limited exposure to an investigational drug. Because of the limited exposure to the investigational drug, safety data will in most cases have to be pooled (combined) across clinical studies in order to enhance the ability to identify and characterize the drug’s risk profile.

Results

Conclusion