Database and Registry Research

Within pharmacoepidemiology research, database studies present both opportunities and limitations. We understand the issues and can help you determine if it is feasible and effective to use databases, and if so, which data source(s), to answer your epidemiology and/or drug safety questions. Database research can help you gain insights on:

  • Medication, device, vaccine, and other treatment safety profiles
  • Disease prevalence and public health impact
  • Event rates
  • Patient characteristics
  • Treatment patterns and drug utilization
  • Medication adherence and persistence
  • Comparative effectiveness and value of alternative treatments
  • Validity of electronic database information to identify specific disease endpoints  

In addition to pharmaceutical clients, our experts have conducted database safety studies at the request of FDA, EMA, and other national agencies in North America, Europe, and the Asian Pacific region.

Select the Best Data Source

We have conducted research in populations covered by electronic medical records, administrative claims, and registries for several decades. However, for each project, we identify and access the most appropriate database(s) for the study. Moreover, we develop and validate exposure, outcomes, and covariates through structured coding of data (e.g., diagnosis codes), unstructured data (e.g., clinical notes), and combinations of both, appropriate to the database(s). We have experience working with the following data sources, directly or through collaborative research partnerships:

Country Database
Canada Saskatchewan Health
Denmark Danish National and regional registries*
Italy Friuli-Venezia Giulia databases*
Netherlands PHARMO Institute Data*
Nordic Countries Scandinavian Sarcoma Group 
Spain Aragon Institute of Health Sciences (IACS)*
Information System for the Development of Research in Primary Care (SIDIAP)*
Sweden Swedish National Registries*
United Kingdom Clinical Practice Research Datalink (CPRD) (previously GPRD)
The Health Improvement Network (THIN)
United States HealthCore Integrated Research Database (HIRD)*
Henry Ford Health System*

Integrated Health Care Information Services (IHCIS) Managed Care Benchmark Database*
Kaiser Permanente of Northern California
Kaiser Permanente of Southern California
Kaiser Permanente of Washington
LifeLink (formerly PharMetrics)

Medicare and Medicaid administrative claims
National Death Index (NDI)
National Center for Health Statistics surveys
Optum
Regenstrief Institute 
Surveillance, Epidemiology and End Results (SEER) cancer registries
SEER-Medicare linked data
Statewide cancer registries in the US
Truven MarketScan Commercial Claims and Encounters (CCAE) database
Truven MarketScan Health and Productivity Management (HPM) database

* We work collaboratively with these organizations to design studies and provide specifications for analyses. Analyses are conducted at the custodian institution.

Coordinating Center for Studies using Multiple Databases

Increasingly, safety studies require a sample size exceeding that available from a single database—and if you have such a need, we can help. Our project experience includes serving as a coordinating center for studies that utilize multiple databases. For example, we coordinated research across 11 US databases using a data model based on the US Sentinel Network project. Other multi-database projects can be found among studies in the EU PAS register.

 

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