CEEOR

It is broadly acknowledged that, while randomized clinical trials provide the “gold standard” in the sense that they provide solid evidence of product efficacy under carefully controlled conditions, they are carried out using selected populations under idealized conditions. In addition, they are expensive to conduct. Other data sources can contribute to the evidence base in important ways (e.g., demonstrating how a drug works in populations or under conditions not studied in the trial, or relative to another drug not included in the study).

PatientMonitor™ is a software tool facilitating data capture and data analysis from patient registries and other types of post-approval studies. In addition, the most important descriptive statistics are generated in real-time online and can be followed throughout the course of the study. PatientMonitor™ follows up a cohort of patients using their identification numbers. Irregular repeated visits can be tracked with all clinically relevant records as well as treatment intervention and economic parameters. PatientMonitor™ thus helps to understand the natural history of a disease, to assess real-world safety and effectiveness, quality of care and provider performance, prescribing patterns and cost-effectiveness of monitored strategies. The necessary regulatory issues may be arranged by CEEOR within a reasonably short time interval.

There are several applications of PatientMonitor™ for collecting real-world data depending on the type of data collected; disease- or product-oriented registries may be focused on clinical, health economics, intervention or patient-reported outcomes. CEEOR can provide a catalog of health economics questionnaire items for all major medical areas.