TY - JOUR
T1 - Development of predictive genetic tests for improving the safety of new medicines
T2 - The utilization of routinely collected electronic health records
AU - Wing, Kevin
AU - Douglas, Ian
AU - Bhaskaran, Krishnan
AU - Klungel, Olaf H.
AU - Reynolds, Robert F.
AU - Pirmohamed, Munir
AU - Smeeth, Liam
AU - Van Staa, Tjeerd P.
N1 - Funding Information:
I.D. is funded by an MRC methodology fellowship; K.B. is funded by a post-doctoral fellowship from the National Institute of Health Research ; L.S. is funded by a Wellcome Trust Senior Clinical Fellowship ; and M.P. and L.S. are NIHR senior investigators. The views expressed are those of the authors only and not of their respective institutions, companies, or other bodies/committees that they might be associated with.
Funding Information:
The research leading to these results was conducted as part of the PROTECT consortium (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium, http://www.imi-protect.eu ), which is a public-private partnership coordinated by the European Medicines Agency. The PROTECT project has received support from the Innovative Medicine Initiative Joint Undertaking ( http://www.imi.europa.eu ) under Grant Agreement n° 115004, resources of which comprise financial contribution from the European Union's Seventh Framework Programme (FP7/2007–2013) and EFPIA companies’ in kind contribution. In the context of the IMI Joint Undertaking (IMI JU), the London School of Hygiene and Tropical Medicine and the Department of Pharmacoepidemiology, Utrecht University, received direct financial contributions from Pfizer .
PY - 2014/4/1
Y1 - 2014/4/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84899537758&partnerID=8YFLogxK
U2 - 10.1016/j.drudis.2013.11.003
DO - 10.1016/j.drudis.2013.11.003
M3 - Short survey
C2 - 24239729
AN - SCOPUS:84899537758
SN - 1359-6446
VL - 19
SP - 361
EP - 366
JO - Drug Discovery Today
JF - Drug Discovery Today
IS - 4
ER -