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

Olaf H Klungel1,2, Xavier Kurz3, Mark C H de Groot1,4

  • 1Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, Utrecht, the Netherlands.

Pharmacoepidemiology and Drug Safety
|April 3, 2016
PubMed
Summary
This summary is machine-generated.

A network of databases consistently linked drug classes to adverse events, enhancing confidence in observational drug research. Some drug-suicidality associations were inconsistent, but others like antibiotics and acute liver injury were reliable.

Keywords:
European Medicines AgencyInnovative Medicines InitiativePROTECTelectronic healthcare databasesmethodologyobservational studiespharmacoepidemiologypharmacoepidemiology (PE)

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Area of Science:

  • Pharmacovigilance and Pharmacoepidemiology
  • Drug Safety Research
  • Methodological Validation in Observational Studies

Background:

  • Observational studies are crucial for drug safety assessment.
  • Methodological variations can impact findings on drug-adverse event associations.
  • Ensuring consistency across studies is vital for reliable benefit/risk assessments.

Purpose of the Study:

  • To evaluate how different methodological parameters influence the observed associations between specific drug classes and key adverse events.
  • To assess the consistency of drug-adverse event associations across multiple databases and analytical approaches.
  • To establish a robust network for conducting reproducible observational drug effect studies.

Main Methods:

  • Selected Drug-Adverse Event pairs based on public health impact and regulatory relevance.
  • Developed common protocols and data analytical specifications for independent, blinded execution across European databases.
  • Replicated study designs within and across different databases to ensure robustness.

Main Results:

  • Consistent associations were found for antibiotics and acute liver injury, benzodiazepines and hip fracture, antidepressants and hip fracture, and inhaled long-acting beta2-agonists and acute myocardial infarction across various methods.
  • Some variation in the magnitude of associations was noted due to differing exposure/outcome definitions, but these were not statistically significant.
  • Inconsistent associations were observed for anti-epileptics and suicidality across databases, while calcium channel blockers showed no association with cancer risk.

Conclusions:

  • A network facilitating common protocol execution across multiple databases for observational drug effect studies has been successfully established.
  • Increased consistency in findings across diverse designs and international databases enhances confidence in observational drug research.
  • The developed network and improved consistency will aid in more reliable drug benefit/risk assessments.