Pharmacoepidemiology - The Basics

Pharmacoepidemiology - The Basics

Dr. Annette Stemhagen,  Senior Vice President, Safety, Epidemiology, Registries and Risk Management, and Dr. Robert Sharrar, Executive Director, Safety, Epidemiology, Registries and Risk Management, led an informative tutorial on pharmacoepidemiology this week at the DIA Pharmacovigilance and Risk Management conference.

The tutorial provided an introduction to the topic, including an overview of the different concepts, types, and methods used in pharmacoepidemiology.  Drs. Stemhagen and Sharrar made the topic easily digestible for all levels – from novice to expert. Here are the key takeaways:

• Pharmacoepidemiology has a place in all phases of drug development, pre- and post-marketing
     o Preclinical through Phase II – Conduct natural history of disease  studies to understand the disease for which the product is being developed
     o Phase III – Inform pivotal clinical trials of  efficacy and safety by understanding characteristics of patients with the disease and their outcomes
     o Phase IV – Determine safety of the product as used in a “real world” population

• To be in accordance with regulations and guidelines – follow three rules of thumb:
     o Have a PROACTIVE approach
     o FOCUS on specific issues identified
     o Be TRANSPARENT in all you do

• Consider a number of different study types (e.g., descriptive, analytical, experimental)

• Beyond effectiveness and safety, companies now must demonstrate product value. Manufacturers should consider these study methods:
     o Chart reviews
     o Observational prospective, cross-sectional and case-control studies
     o Time and motion studies
     o Patient and physician surveys

Participant engagement in the session made it clear that regulatory requirements and the pharmacoepidemiology methods required to meet these requirements are not black and white. Methods used require a great deal of thought, and a variety of epidemiology methods may be needed to evaluate product safety and value after the product is launched in the marketplace.  One thing, however, is certain — the need for information is constant.