Professor David Henry - How distributed networks of population data centres are changing the way in which we investigate serious adverse effects of prescription medicines

Abstract

Historically, adverse effects of medicines have been identified through spontaneous adverse reaction reporting followed by ‘ad hoc’ studies designed to quantify risk.  Widespread access to large linked routinely collected databases made this process more efficient, but it often takes years for separate research groups to collectively address an important safety question. In response, several collaborations have formed internationally that enable simultaneous analyses of data bases in multiple jurisdictions. The Canadian Network for Observational Drug Effect Studies was established in 2011 and since then 120 researchers in 8 provinces have performed over 120 analyses of large population data-bases from 10 jurisdictions. This work has confirmed specific risks or demonstrated relative safety of several major drug classes, including anti-microbials, anti-psychotics, incretin-based drugs, opioids, statins, retinoids, acid pump inhibitors, anticoagulants, biologics and anti-emetics. Distributed analysis ensures that a common analytical protocol is applied to multiple data-bases, comprising a possible total population of 100 million or more. A Methods team ensures consistency of work across sites and monitors factors that might introduce bias into treatment effect estimates.  A COI management policy limits the roles of individuals who have any links to manufacturers and a knowledge translation group.

Speaker Bio

David Henry , (Bond University)

Is a Professor at the Institute for Evidence-Based Healthcare at Bond University. He also holds conjoint positions at the University of Newcastle, University of Melbourne and an Emeritus Chair at the University of Toronto. He also worked as an internal medicine specialist for many years after completing training in clinical pharmacology and gastroenterology. His research has been mainly in the fields of pharmacoepidemiology and WHO medicines policies in both high- and low-income countries. He was active in the development of drug subsidization programs in Australia and South Africa.