Critical review of the TransCelerate Template for clinical study reports (CSRs) and publication of Version 2 of the CORE Reference ( C larity and O penness in R eporting: E 3-based) Terminology Table.

Autor: Hamilton S; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; Sam Hamilton Medical Writing Services Limited, Newcastle Upon Tyne, UK., Bernstein AB; 2American Medical Writers Association, 30 W. Gude Drive, Ste. 525, Rockville, MD 20850-4347 USA.; Aaron Bernstein Consulting, LLC, Millburn, NJ USA., Blakey G; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; Consult2Deliver, BioCity, Pennyfoot Street, Nottingham, NG1 1GF UK., Fagan V; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; 6IQVIA, The Alba Campus, Rosebank, Livingston, West Lothian EH54 7EG UK., Farrow T; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; PPD, Granta Park, Great Abingdon, Cambridge, CB21 6GQ UK., Jordan D; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; Debbie Jordan Limited, Hook, Hampshire UK., Seiler W; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; 9Bayer AG, 13342 Berlin, Germany., Gertel A; European Medical Writers Association, Chester House, 68 Chestergate, Macclesfield, Cheshire SK11 6DY UK.; 2American Medical Writers Association, 30 W. Gude Drive, Ste. 525, Rockville, MD 20850-4347 USA.; MedSciCom, LLC, Lebanon, NJ USA.
Jazyk: angličtina
Zdroj: Research integrity and peer review [Res Integr Peer Rev] 2019 Aug 05; Vol. 4, pp. 16. Date of Electronic Publication: 2019 Aug 05 (Print Publication: 2019).
DOI: 10.1186/s41073-019-0075-5
Abstrakt: Background: CORE ( C larity and O penness in R eporting: E 3-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.
Methods: The 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.
Results: Our 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'.
Conclusions: As 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.
Registration: CORE 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.
Competing Interests: Competing interestsAll BWG team members declare that they: (1) have provided, or do provide, ethical professional services to academic, biotechnology, or pharmaceutical clients and (2) are active in national and international not-for-profit associations that encourage ethical professional practices. BWG team members are volunteers and are not paid for the time they dedicate to this project. They are all employees of their respective companies or are freelance contractors or consultants.
Databáze: MEDLINE
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