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Database Studies

Retrospective databases are an important data source for outcomes research. Our Cytel RWE team is well equipped to prepare and conduct a wide range analyses based on retrospective claims data, EMR and health registries.

Retrospective database studies on epidemiology, treatment patterns and HCRU/Cost

Epidemiology, treatment patterns and HCRU/cost studies form the basis for a great deal of our work. They allow researchers to examine healthcare resource use and treatment as it occurs in routine clinical practice, with access to large unbiased study populations and long observation periods (including baseline and follow-up).

This makes databases a unique resource for researching epidemiology, treatment patterns, and healthcare resource utilization (HCRU). Researchers performing retrospective database studies face a series of methodological challenges related to the correct identification of patients based on diagnostic codes/treatments, identification of treatment patterns alongside challenging treatment paradigms (such as combination or maintenance treatments), and a methodologically sound extrapolation of epidemiological results.

Thanks to our worldwide network of experienced epidemiologists, statisticians, health economists and clinicians, Cytel RWE provides clients with the right solutions to address the above challenges.

Retrospective database studies on comparative effectiveness

If there is more than one treatment on the market for a specific disease and, as is typically the case, no head-to-head randomized clinical trials to compare these treatments, retrospective comparative effectiveness studies can be an important supplement for evidence from clinical trials and prospective observational studies. The advantages of these studies are large, unbiased patient samples with long baseline and follow-up durations.

Cytel RWE’s experience and expertise in this area means we leverage methods such as (high dimensional) propensity score matching, multivariable analysis techniques, negative control analyses, and other advanced tools to compare effectiveness between treatments, patient groups, or both treatments and patient groups simultaneously.

Retrospective database studies: Post-approval safety studies

Post-approval safety studies (PASS) are done for a variety of reasons: to improve market access, to show the superior safety profile of a treatment, or because regulatory or HTA bodies require such studies. Spontaneous adverse event reporting and registries often suffer from an underreporting of adverse events. Sometimes, they only observe selected patient populations. By contrast population-based database studies on safety are by far a better instrument to cover these type of evidence needs.

Cytel RWE’s extensive experience with claims and registry databases helps ensure the validity and quality of your product’s safety data, including a proper validation of the reported outcomes. 

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