Choosing the right data for the right purpose
Read world evidence (RWE) is an integral part of the evidence base of every medical technology or drug. Historically it originated from the concept of studying “effectiveness” (effect under real conditions such as the presence of comorbidities, treatment practice etc.) vs “efficacy (effect in a randomized controlled trial (RCT) with very strict inclusion and exclusion criteria, well-defined treatment approach etc.). Eventually, every technology on the market will be used in real clinical settings. However, over the past couple of decades, with technical evolution and increased availability of claims databases and patient registries, they have started to be used to generate unique insights into patient pathways, treatment patterns, burden of disease, prediction of response to drug or medical technology and economics.
RWD is more than electronic health records
Industry-sponsored real world evidence research is often biased towards claims databases. Due to their relatively easy accessibility, claims databases (developed by both state and private organizations) are widely used to answer a variety of questions from burden of disease and cost of care to supporting the design of clinical studies.
However, most research questions, except for economics or characterization of a patient population, can be better answered using patient registries. Patient registries, with large lists of included variables and long follow-ups, present an invaluable source of research which is currently underutilized. Registries are the only available source of information with a comprehensive medical history, clinical and laboratory parameters, and clinical and quality of life outcomes. They have a great potential for industry but are not yet fully utilized.
There are number of research questions which should only be addressed with high-quality patient registry data and not claims database data:
- Selection of predictors of response to a drug or medical technology
- Studying effectiveness
- Studying health-related quality of life
The common reason why industry is not actively using patient registries and evidence originated from them is lack of awareness about the source and the process of gaining access to it. Lack of good overview of what RWE is available prevents industry from the most efficient evidence generation effort and addressing payer and HTA questions.
Based on your research questions, you should identify the appropriate data-set that includes the right scope of data. For some research questions, electronic health records will be sufficient, but frequently patient / disease registries are the preferred option with their ability to provide a rich data-set. This overview gives high level guidance of when to choose which type of data-set.
Learn more about our solution my-RWE that give you insight to shape your real world evidence strategy