The same principles and approaches to data collection as for other pharmacoepidemiological studies can be followed (see section 3 of this Guide on Approaches to Data Collection). An efficient approach to data collection for pharmacogenetic studies is to combine secondary use of electronic health records with primary data collection (e.g. biological samples to extract DNA).
Examples are given by SLCO1B1 genetic variant associated with statin-induced myopathy: a proof-of-concept study using the clinical practice research datalink (Clin Pharmacol Ther 2013;94(6):695-701), Diuretic therapy, the alpha-adducin gene variant, and the risk of myocardial infarction or stroke in persons with treated hypertension (JAMA 2002;287(13):1680-9) and Interaction between the Gly460Trp alpha-adducin gene variant and diuretics on the risk of myocardial infarction (J Hypertens 2009 Jan;27(1):61-8). Another approach to enrich electronic health records with biological samples is record linkage to biobanks as illustrated in Genetic variation in the renin-angiotensin system modifies the beneficial effects of ACE inhibitors on the risk of diabetes mellitus among hypertensives (Hum Hypertens 2008;22(11):774-80). A third approach is to use active surveillance methods to fully characterise drug effects such that a rigorous phenotype can be developed prior to genetic analysis. This approach was followed in Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals (Pharmacoepidemiol Drug Saf 2009;18(8):713-21) and EUDRAGENE: European collaboration to establish a case-control DNA collection for studying the genetic basis of adverse drug reactions (Pharmacogenomics 2006;7(4):633-8).
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|