The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework.

ABSTRACT: To complement real-world evidence (RWE) guidelines, the 2019 Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent real-world Evidence (SPACE) framework elucidated a process for designing valid and transparent real-world studies. As an extension to SPACE, here, we provide a structured framework for conducting feasibility assessments-a step-by-step guide to identify decision grade, fit-for-purpose data, which complements the United States Food and Drug Administration (FDA)'s framework for a RWE program. The process was informed by our collective experience conducting systematic feasibility assessments of existing data sources for pharmacoepidemiology studies to support regulatory decisions. Used with the SPACE framework, the Structured

SUBMITTER: Gatto NM 

PROVIDER: S-EPMC9299818 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature