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Critical review of the TransCelerate Template for clinical study reports (CSRs) and publication of Version 2 of the CORE Reference (Clarity and Openness in Reporting: E3-based) Terminology Table

Authors
  • Hamilton, Samina
  • Bernstein, Aaron B.
  • Blakey, Graham
  • Fagan, Vivien
  • Farrow, Tracy
  • Jordan, Debbie
  • Seiler, Walther
  • Gertel, Art
Type
Published Article
Journal
Research Integrity and Peer Review
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Aug 05, 2019
Volume
4
Issue
1
Identifiers
DOI: 10.1186/s41073-019-0075-5
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundCORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user’s guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE Reference as one of two principal sources used in its development.MethodsThe regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.ResultsOur major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference ‘Terminology Table’ Version 2 includes estimand as a defined term and an adaptation of the original ‘worked study example’ to incorporate the recently evolved concept of ‘estimands’.ConclusionsAs TransCelerate’s CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.RegistrationCORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper.

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