Comprehensive Retrospective Study on Patient Safety

A clinical trial had assessed the client drug’s safety profile and specified relative risk estimates based on the trial outcomes data. To interpret these estimates—and thereby develop the product’s value proposition—the client needed to know the incidence and prevalence rates of safety outcomes among real-world patients enrolled in commercial, Medicaid managed care, Medicare Advantage (MA), and Medicare fee-for-service (FFS) plans.

We conducted a retrospective claims analysis—using Avalere’s access to Inovalon’s Medical Outcomes Research for Effectiveness and Economics (MORE²) Registry® for the commercial, Medicaid managed care, and MA markets, and FFS data for the traditional Medicare market—to profile adverse effects associated with the client’s drug.

We stratified study cohorts into patients with the disease and patients without the disease, and then subclassified them to reflect sub-cohorts matching ongoing clinical trials. We adjusted adverse event estimates to mitigate the effects of confounding variables and tailored outcome measures to capture all relevant safety outcomes, all of which were related to cardiac safety and major adverse cardiovascular events. We then generated descriptive summary measures and conducted several comparative studies to assess how safety outcomes of interest varied randomly or systematically across populations. These studies yielded baseline incidence and prevalence rates for selected safety outcomes.

The client can use baseline incidence and prevalence rates for selected safety outcomes as determined in this study to refine its research and clinical trial strategy and generate the evidence needed to understand the safety profile and articulate the value proposition of its drug.