The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework.
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SUBMITTER: Gatto NM
PROVIDER: S-EPMC9299818 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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The Structured Process to Identify Fit-For-Purpose Data: A Data Feasibility Assessment Framework.
Gatto Nicolle M NM Campbell Ulka B UB Rubinstein Emily E Jaksa Ashley A Mattox Pattra P Mo Jingping J Reynolds Robert F RF
Clinical pharmacology and therapeutics 20211201 1
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 Foo ...[more]
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