Development of predictive genetic tests for improving the safety of new medicines: the utilization of routinely collected electronic health records.
Serious adverse drug reactions are an important cause of hospitalization and can result in the withdrawal of licensed drugs. Genetic variation has been shown to influence adverse drug reaction susceptibility, and predictive genetic tests have been developed for a limited number of adverse drug reactions. The identification of patients with adverse drug reactions, obtaining samples for genetic analysis and rigorous evaluation of clinical test effectiveness represent significant challenges to predictive genetic test development. Using the example of serious drug-induced liver injury, we illustrate how a database of routinely collected electronic health records (EHRs) could be used to overcome these barriers by facilitating rapid recruitment to genome-wide association studies and supporting efficient randomized controlled trials of predictive genetic test effectiveness.
Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: kevin.wing@lshtm.ac.uk.
Kevin
K
Wing
Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Ian
I
Douglas
Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Krishnan
K
Bhaskaran
Department of Pharmacoepidemiology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.
Olaf H
OH
Klungel
Epidemiology, Pfizer, New York, NY, USA.
Robert F
RF
Reynolds
The Wolfson Centre for Personalised Medicine, Department of Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.
Munir
M
Pirmohamed
Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.
Liam
L
Smeeth
Department of Non-communicable Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK; Department of Pharmacoepidemiology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands; Clinical Practice Research Datalink (CPRD), Medicines and Healthcare Products Regulatory Agency, London, UK.
Tjeerd P
TP
van Staa
D056486:Chemical and Drug Induced Liver Injury / Q000517:prevention & control; D016208:Databases, Factual; D055808:Drug Discovery; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control*; D057286:Electronic Health Records; D005820:Genetic Testing; D055106:Genome-Wide Association Study; D006801:Humans