Journal article
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance
- Abstract:
- The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote greater clarity, reproducibility, informativeness, and usefulness of results.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 400.3KB, Terms of use)
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- Publisher copy:
- 10.1136/bmj-2023-076387
Authors
+ Cancer Research UK
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- Funder identifier:
- https://ror.org/054225q67
- Grant:
- 11650
+ Medical Research Council
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- Funder identifier:
- https://ror.org/03x94j517
- Grant:
- MR/N026977/1
- MR/S014357/1
- MR/W020483/1
- Publisher:
- BMJ Publishing Group
- Journal:
- British Medical Journal More from this journal
- Volume:
- 383
- Article number:
- e076387
- Place of publication:
- England
- Publication date:
- 2023-10-20
- Acceptance date:
- 2023-08-05
- DOI:
- EISSN:
-
0959-8138
- ISSN:
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1759-2151
- Pmid:
-
37863501
- Language:
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English
- Keywords:
- Pubs id:
-
1549012
- Local pid:
-
pubs:1549012
- Deposit date:
-
2025-03-31
- ARK identifier:
Terms of use
- Copyright date:
- 2023
- Rights statement:
- This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.
- Licence:
- CC Attribution (CC BY)
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