Administrative healthcare claims databases are commonly used in health economics and outcomes research. However, the information within these claims databases were initially intended for administrative or billing purposes and typically don't include clinical details which could impact study outcomes. Alternative sources of patient data that include clinical information are clinical trials and registries.
Clinical trial data analytics
Randomized clinical trials are the gold standard source of clinical data for determining the safety and efficacy of treatment interventions. However, a single clinical trial may be underpowered with a patient sample size that is insufficient to determine an outcome with statistical certainty. Combining comparable clinical trials can create a patient population that is sufficient for analysis. In addition, while clinical trials are conducted to determine a particular set of outcomes, comprehensive clinical information is collected for each patient. This supplemental data& can be used to retrospectively analyze other outcomes. Pooled trial analyses, meta-analyses, and post-hoc analyses are routinely performed by Novosys Health team members using data from clinical trials in a wide range of therapeutic areas.
Registry data analytics
Patient or disease registries are databases that collect the clinical data of patients with a particular diagnosis or medical condition, or have undergone a specific procedure. Unlike clinical trials, where patients must meet specific inclusion and exclusion criteria, patients are typically not excluded from registries, making study results more generalizable. In addition, registries often collect patient data over a long period of time, allowing for the assessment of long-term outcomes. They are an effective method of observing real-world clinical practice. Novosys Health can design and execute a registry data analysis as a stand-alone study or to complement an administrative database analysis.
Once-daily prandial lixisenatide versus once-daily rapid-acting insulin in patients with type 2 diabetes mellitus insufficiently controlled with basal insulin: analysis of data from five randomized, controlled trials. J Diabetes Complications. 2013
Efficacy and safety of lixisenatide in Japanese patients with type 2 diabetes mellitus: a meta-analysis of 2 randomized controlled trials. European Association for the Study of Diabetes (EASD) Annual Meeting, 2013
Efficacy and safety of lixisenatide in elderly type 2 diabetes mellitus patients: subanalysis from the GetGoal program. European Association for the Study of Diabetes (EASD) Annual Meeting, 2013
Basal insulin + lixisenatide induces less symptomatic hypoglycemia and weight gain than basal bolus. American Diabetes Association (ADA) Annual Meeting, 2013
Glycemic control and hypoglycemia prevalence in Chinese T2DM patients treated with insulin glargine or NPH: an analysis of the FINE Asia registry population. Chinese Diabetes Society (CDS) Annual Conference, 2012