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Review
. 2022 Jan;111(1):122-134.
doi: 10.1002/cpt.2466. Epub 2021 Dec 1.

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

Nicolle M Gatto  1   2   3 , Ulka B Campbell  2   4 , Emily Rubinstein  1 , Ashley Jaksa  1 , Pattra Mattox  1 , Jingping Mo  4 , Robert F Reynolds  3   5
Affiliations
Review

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

Nicolle M Gatto et al. Clin Pharmacol Ther. 2022 Jan.

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 Process to Identify Fit-For-Purpose Data (SPIFD) provides a systematic process for conducting feasibility assessments to determine if a data source is fit for decision making, helping ensure justification and transparency throughout study development, from articulation of a specific and meaningful research question to identification of fit-for-purpose data and study design.

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Conflict of interest statement

The following personal or financial relationships relevant to this manuscript existed during the conduct of the study: N.G., E.R., A.J., and P.M. are employees of and hold stock options or equity in Aetion Inc. R.R. is an employee of GlaxoSmithKline. U.C. and J.M. are employees of Pfizer Inc. N.G., E.R., U.C., J.M., and R.R. hold stock options in Pfizer Inc. The views expressed herein are the authors and not necessarily those of GlaxoSmithKline or Pfizer.

Figures

Figure 1
Figure 1
RWE decision support: data questions. RWD, real‐world data; RWE, real‐world evidence; SPIFD, Structured Process to Identify Fit‐For‐Purpose Data.
Figure 2
Figure 2
Overview of combined SPACE and SPIFD frameworks with templates and tools for documentation. Note: SPACE tables 1 and 2, and figure 6 are from Gatto et al. SPACE, Structured Preapproval and Postapproval Comparative study design framework to generate valid and transparent real‐world Evidence; SPIFD, Structured Process to Identify Fit‐For‐Purpose Data.
Figure 3
Figure 3
SPIFD step 2: Identify and narrow data source options. SPIFD, Structured Process to Identify Fit‐For‐Purpose Data.
Figure 4
Figure 4
Case Example 1: SPIFD step 2 prospectively applied to COVID‐19 treatment study. COVID‐19, coronavirus disease 2019; SPIFD, Structured Process to Identify Fit‐For‐Purpose Data.
Figure 5
Figure 5
Case Example 1: SPIFD step 3 heatmap prospectively applied to COVID‐19 treatment study. COVID‐19, coronavirus disease 2019; mWHO, modified version of WHO ordinal scale; SPIFD, Structured Process to Identify Fit‐For‐Purpose Data.
See this image and copyright information in PMC

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