Objective
The task force will establish emerging good practices for transparent and pre-specified feasibility assessment of identified real-world data (RWD) sources to support non-interventional real-world evidence (RWE) study proposals fit for regulatory agency submissions.
Rationale
Both health authority agencies and academics are calling for the need to document data checks conducted during development of study design, proposals, and protocols prior to study initiation to avoid using already collected data to influence study outcomes, an important concern for real-world evidence (RWE) studies. At the same time, this need must be balanced with determining the feasibility of studying the desired outcomes.
Despite existing frameworks to assess data relevance and reliability and identify sources fit for purpose for regulatory submissions, there is currently no good practice guidance addressing detailed, transparent feasibility assessments of candidate RWD sources prior to regulatory engagement, including how to pre-specify, document, and communicate these assessments.
An ISPOR multistakeholder task force can address this gap by developing a scientifically driven roadmap and emerging good practices to support feasibility assessments and study proposals. This will improve the quality, transparency, and consistency of RWE study proposals, strengthen scientific rigor, and better align evidence generation with evolving regulatory expectations.