Evaluating the Feasibility of Electronic Health Records and Claims Data Sources for Specific Research Purposes

Data collected in real-world clinical settings are increasingly being used to evaluate therapeutic options. While in its infancy for research assessing effectiveness, especially comparative effectiveness in the regulatory environment, electronic health records (EHR) and administrative insurance claims data are used extensively by both manufacturers and regulators to evaluate post-marketing safety of products in the real world. The feasibility of using these data for analysis in a research study depends on the specific research question and the availability, quality and relevance of the collected data to address the scientific question. It is unlikely that any specific database could be 'qualified' for use across all research questions, even within a specific therapeutic area, due to dependence of feasibility on the elements of the specific research question. This paper describes considerations for determining whether EHR or claims data can be used for specific research purposes. A new structured approach for assessing the feasibility of these data in research is proposed. The framework builds on and considers whether each element of the PICOTS framework for well-structured research questions is adequately captured to allow for viable reliance on EHR and claims data for that specific scientific question. Practical examples and discussion of the limitations of RWD for research are given along with approaches for interpretation of analyses using RWD.