Multi-centre, multi-database studies with common protocols: Lessons learnt from the IMI PROTECT project

Autor: Klungel, Olaf H., Kurz, Xavier, de Groot, Mark C. H., Schlienger, Raymond G., Tcherny-Lessenot, Stephanie, Grimaldi, Lamiae, Ibáñez, Luisa, Groenwold, Rolf H. H., Reynolds, Robert F., Alvarez, Y., Candore, G., Durand, J., Slattery, J., Hasford, J., Rottenkolber, M., Schmiedl, S., de Abajo Iglesias, F., Gil, M., Gonzalez, R., Huerta Alvarez, C., Martin, E., Oliva, B., Requena, G., Amelio, J., Brauer, R., Downey, G., Feudjo-Tepie, M., Schoonen, M., Johansson, S., Robinson, J., Gallagher, A., Ng, E., van Staa, T.P., Davis, K., Abbing-Karahagopian, V., Ali, S., Belitser, S., de Boer, Anthonius, De Bruin, M.L., Egberts, A.C.G., van Dijk, L., Gardarsdottir, H., Leufkens, H.G.M., Souverein, P., Uddin, J., van den Ham, H.A., Voogd, E., de Vries, Frank, Udo, R., Sub Pharmacotherapy, Theoretical, Sub Gen. Pharmacoepi and Clinical Pharm, Sub Pharmacoepidemiology, Sub Clinical Pharmacy, Pharmacoepi, Pharmacoepidemiology and Clinical Pharmacology
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Pharmacoepidemiology (PE)
pharmacoepidemiology
anticonvulsive agent
study design
data base
European Medicines Agency
Taverne
antibiotic agent
antidepressant agent
human
Innovative Medicines Initiative
replication study
Observational studies
outcome assessment
suicide
benzodiazepine derivative
long acting drug
beta 2 adrenergic receptor stimulating agent
Methodology
tricyclic antidepressant agent
article
asthma
case control study
long acting beta 2 adrenergic receptor stimulating agent
unclassified drug
acute heart infarction
confounding variable
calcium channel blocking agent
priority journal
risk factor
PROTECT
hip fracture
depression
serotonin uptake inhibitor
epilepsy
observational study
Electronic healthcare databases
clinical protocol
chronic obstructive lung disease
neoplasm
liver injury
Zdroj: Pharmacoepidemiology and Drug Safety, 25(supplement S1), 156. John Wiley and Sons Ltd
ISSN: 1053-8569
Popis: Purpose: To assess the impact of a variety of methodological parameters on the association between six drug classes and five key adverse events in multiple databases. Methods: The selection of Drug-Adverse Event pairs was based on public health impact, regulatory relevance, and the possibility to study a broad range of methodological issues. Common protocols and data analytical specifications were jointly developed and independently and blindly executed in different databases in Europe with replications in the same and different databases. Results: The association between antibiotics and acute liver injury, benzodiazepines and hip fracture, antidepressants and hip fracture, inhaled long-acting beta2-agonists and acute myocardial infarction was consistent in direction across multiple designs, databases and methods to control for confounding. Some variation in magnitude of the associations was observed depending on design, exposure and outcome definitions, but none of the differences were statistically significant. The association between anti-epileptics and suicidality was inconsistent across the UK CPRD, Danish National registries and the French PGRx system. Calcium channel blockers were not associated with the risk of cancer in the UK CPRD, and this was consistent across different classes of calcium channel blockers, cumulative durations of use up to >10years and different types of cancer. Conclusions: A network for observational drug effect studies allowing the execution of common protocols in multiple databases was created. Increased consistency of findings across multiple designs and databases in different countries will increase confidence in findings from observational drug research and benefit/risk assessment of medicines.
Databáze: OpenAIRE
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