Real world data – the use of data from the real world of daily clinical work to generate evidence (real world evidence, RWE), in support of the value of new intervention is popular and a hot topic of recent years in market access, and in general for the life science industry and healthcare. In many ways RWD is a repurposing of epidemiologic studies to address specific evidence gaps in value demonstration.
A popular epidemiologic study type in RWE is the historical cohort study. In a classic cohort study, two groups, one exposed and one unexposed, are followed over a specific follow-up time and compared with the outcome reported as a relative risk or risk difference.
In a retrospective or historic cohort study the data on exposure or disease has already been collected – this has obvious advantages with regards to time and expense. However, this type of studies relies on that relevant data is collected in a systematic way for adequate samples. In the Nordics we are blessed with the combination of unique personal identification numbers (PINs), several population based health registers with close to 100% coverage allowing for both the detection of exposure and follow-up.
The study of rare disease is particular well suited for the Nordics – the epidemiologic study of rare disease requires the study population to be large (how about the entire population of Sweden?) or with long follow-up (the Swedish cancer register was established 1958!). Often, when the incidence of a disease is low, the preferred epidemiologic study type is the case-control. In a case-control study a group of individuals with a particular disease (case) and a group of individuals without the disease (control) are studied. Case-control studies are particularly well suited in the Nordics with the PIN and high quality health registers, allowing for the easy use of population based control samples.
Here at NMA we have long experience with RWE studies both using Nordic registries and other datasets across the world and are happy to support you in the development and execution of your study.
We’d also like to demonstrate to you how RWE may be generated in alternative ways to full blown epidemiological studies – contact us for more information!