Fit For Purpose RWD | Droice Labs

Fit For Purpose RWD

Explore the key elements that make RWD fit for purpose to address the research questions at hand – data relevance and reliability – and how to ensure RWD is fit for purpose for clinical trials.

RWD Reliability

Characterizing RWD Quality and Relevancy for Regulatory Purposes

Paper

Duke

RWD Reliability

A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real-World Evidence for Regulatory Decisions

Paper

CPT

RWD Reliability

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

Paper

CPT

RWD Reliability

A Structured Process to Identify Fit-for-Purpose Study Design and Data to Generate Valid and Transparent Real-World Evidence for Regulatory Uses

Paper

CPT

RWD Reliability

SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility

Paper

CPT

RWD Reliability

Staging and clean room: Constructs designed to facilitate transparency and reduce bias in comparative analyses of real-world data

Paper

PDS