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Abstract

CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.


Mayer CS, Williams N, Huser V

AMIA Annu Symp Proc. 2021;2021:438-444.

Abstract:

Many research sponsors require sharing of data from human clinical trials. We created the CONSIDER statement, a set of recommendations to improve data sharing practices and increase the availability and re-usability of individual participant data from clinical trials. We developed the recommendations by reviewing shared individual participant data and study artifacts from a set of completed studies, as well as study data deposited on ClinicalTrials.gov and on several data sharing platforms. The CONSIDER statement is comprised of seven sections including: format, data sharing, study design, case report forms, data dictionary, data de-identification and choice of data sharing platform. We developed several different forms of CONSIDER which includes a brief form (the checklist), a full form (detailed descriptions and examples), and a scoring methodology. The checklist can be used to evaluate adherence to various progressive data sharing recommendations. We are currently in Phase 2 of collecting feedback on the CONSIDER statement.


Mayer CS, Williams N, Huser V CONSIDER Statement: Consolidated Recommendations for Sharing Individual Participant Data from Human Clinical Studies.  
AMIA Annu Symp Proc. 2021;2021:438-444.

PMID | PMCID