Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials: The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance

Christina Yap; Olga Solovyeva; Johann de Bono; Jan  Rekowski; Dhrusti Patel; Thomas Jaki; Thomas R. Jeffry Evans; Richard  Peck; Kathryn S  Hayward; Sally Hopewell; Moreno Ursino; Khadija Rerhou Rantell; Melanie Calvert; Shing Lee; Andrew Kightley; Deborah Ashby; An-Wen Chan; Elizabeth  Garrett Mayer; John D Isaacs; Robert  Golub; Olga  Kholmanskikh; Dawn P. Richards; Oliver  Boix; James Matcham; Lesley  Seymour; S. Percy  Ivy; Lynley V Marshall; Antoine  Hommais; Rong  Liu; Yoshiya  Tanaka; Jordan  Berlin; Aude Espinasse; Munyaradzi Dimairo; Christopher J Weir

doi:10.1136/bmj-2023-076387

Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials: The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance

Christina Yap^*
, Olga Solovyeva
, Johann de Bono
, Jan Rekowski
, Dhrusti Patel
, Thomas Jaki
, Thomas R. Jeffry Evans
, Richard Peck
, Kathryn S Hayward
, Sally Hopewell
, Moreno Ursino
, Khadija Rerhou Rantell
, Melanie Calvert
, Shing Lee
, Andrew Kightley
, Deborah Ashby
, An-Wen Chan
, Elizabeth Garrett Mayer
, John D Isaacs
, Robert Golub

Olga Kholmanskikh, Dawn P. Richards, Oliver Boix, James Matcham, Lesley Seymour, S. Percy Ivy, Lynley V Marshall, Antoine Hommais, Rong Liu, Yoshiya Tanaka, Jordan Berlin, Aude Espinasse, Munyaradzi Dimairo, Christopher J Weir

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	e076387
Number of pages	14
Journal	BMJ
Volume	383
DOIs	https://doi.org/10.1136/bmj-2023-076387
Publication status	Published - 20 Oct 2023

Bibliographical note

Funding: CONSORT-DEFINE is funded by the UK Medical Research Council (MRC)-National Institute for Health and Care Research (NIHR) Methodology Research Programme (grant MR/T044934/1). ICR-CTSU receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351), which has contributed to accelerating the advancement and successful completion of this work. TJ received funding from the MRC (MC_UU_00002/14). DA acknowledges support from the NIHR Imperial Biomedical Research Centre. LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and also acknowledges funding support from the UK’s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Research (ICR) Biomedical Research Centre. The funders and sponsor had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This article reflects personal the views of the authors, the Delphi participants, and the consensus meeting participants, and may not represent the views of the broader stakeholder groups, authors’ institutions, or other affiliations. The personal views may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties, or to any organisation with which the authors are affiliated.

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Yap, C., Solovyeva, O., de Bono, J., Rekowski , J., Patel, D., Jaki, T., Evans, T. R. J., Peck , R., Hayward, K. S., Hopewell, S., Ursino, M., Rantell, K. R., Calvert, M., Lee, S., Kightley, A., Ashby, D., Chan, A.-W., Garrett Mayer , E., Isaacs, J. D., ... Weir, C. J. (2023). Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials: The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance. BMJ, 383, Article e076387. https://doi.org/10.1136/bmj-2023-076387

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title = "Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials: The 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.",

author = "Christina Yap and Olga Solovyeva and \{de Bono\}, Johann and Jan Rekowski and Dhrusti Patel and Thomas Jaki and Evans, \{Thomas R. Jeffry\} and Richard Peck and Hayward, \{Kathryn S\} and Sally Hopewell and Moreno Ursino and Rantell, \{Khadija Rerhou\} and Melanie Calvert and Shing Lee and Andrew Kightley and Deborah Ashby and An-Wen Chan and \{Garrett Mayer\}, Elizabeth and Isaacs, \{John D\} and Robert Golub and Olga Kholmanskikh and Richards, \{Dawn P.\} and Oliver Boix and James Matcham and Lesley Seymour and Ivy, \{S. Percy\} and Marshall, \{Lynley V\} and Antoine Hommais and Rong Liu and Yoshiya Tanaka and Jordan Berlin and Aude Espinasse and Munyaradzi Dimairo and Weir, \{Christopher J\}",

note = "Funding: CONSORT-DEFINE is funded by the UK Medical Research Council (MRC)-National Institute for Health and Care Research (NIHR) Methodology Research Programme (grant MR/T044934/1). ICR-CTSU receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351), which has contributed to accelerating the advancement and successful completion of this work. TJ received funding from the MRC (MC\_UU\_00002/14). DA acknowledges support from the NIHR Imperial Biomedical Research Centre. LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and also acknowledges funding support from the UK{\textquoteright}s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Research (ICR) Biomedical Research Centre. The funders and sponsor had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This article reflects personal the views of the authors, the Delphi participants, and the consensus meeting participants, and may not represent the views of the broader stakeholder groups, authors{\textquoteright} institutions, or other affiliations. The personal views may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties, or to any organisation with which the authors are affiliated.",

year = "2023",

month = oct,

day = "20",

doi = "10.1136/bmj-2023-076387",

language = "English",

volume = "383",

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issn = "1756-1833",

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}

Yap, C, Solovyeva, O, de Bono, J, Rekowski , J, Patel, D, Jaki, T, Evans, TRJ, Peck , R, Hayward, KS, Hopewell, S, Ursino, M, Rantell, KR, Calvert, M, Lee, S, Kightley, A, Ashby, D, Chan, A-W, Garrett Mayer , E, Isaacs, JD, Golub, R, Kholmanskikh, O, Richards, DP, Boix, O, Matcham, J, Seymour, L, Ivy, SP, Marshall, LV, Hommais, A, Liu, R, Tanaka, Y, Berlin, J, Espinasse, A, Dimairo, M & Weir, CJ 2023, 'Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials: The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance', BMJ, vol. 383, e076387. https://doi.org/10.1136/bmj-2023-076387

TY - JOUR

T1 - Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials

T2 - The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance

AU - Yap, Christina

AU - Solovyeva, Olga

AU - de Bono, Johann

AU - Rekowski , Jan

AU - Patel, Dhrusti

AU - Jaki, Thomas

AU - Evans, Thomas R. Jeffry

AU - Peck , Richard

AU - Hayward, Kathryn S

AU - Hopewell, Sally

AU - Ursino, Moreno

AU - Rantell, Khadija Rerhou

AU - Calvert, Melanie

AU - Lee, Shing

AU - Kightley, Andrew

AU - Ashby, Deborah

AU - Chan, An-Wen

AU - Garrett Mayer , Elizabeth

AU - Isaacs, John D

AU - Golub, Robert

AU - Kholmanskikh, Olga

AU - Richards, Dawn P.

AU - Boix, Oliver

AU - Matcham, James

AU - Seymour, Lesley

AU - Ivy, S. Percy

AU - Marshall, Lynley V

AU - Hommais, Antoine

AU - Liu, Rong

AU - Tanaka, Yoshiya

AU - Berlin, Jordan

AU - Espinasse, Aude

AU - Dimairo, Munyaradzi

AU - Weir, Christopher J

N1 - Funding: CONSORT-DEFINE is funded by the UK Medical Research Council (MRC)-National Institute for Health and Care Research (NIHR) Methodology Research Programme (grant MR/T044934/1). ICR-CTSU receives programmatic infrastructure funding from Cancer Research UK (C1491/A25351), which has contributed to accelerating the advancement and successful completion of this work. TJ received funding from the MRC (MC_UU_00002/14). DA acknowledges support from the NIHR Imperial Biomedical Research Centre. LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and also acknowledges funding support from the UK’s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Research (ICR) Biomedical Research Centre. The funders and sponsor had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. This article reflects personal the views of the authors, the Delphi participants, and the consensus meeting participants, and may not represent the views of the broader stakeholder groups, authors’ institutions, or other affiliations. The personal views may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties, or to any organisation with which the authors are affiliated.

PY - 2023/10/20

Y1 - 2023/10/20

N2 - 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.

AB - 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.

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U2 - 10.1136/bmj-2023-076387

DO - 10.1136/bmj-2023-076387

M3 - Article

SN - 1756-1833

VL - 383

JO - BMJ

JF - BMJ

M1 - e076387

ER -

Enhancing Reporting Quality and Impact of Early Phase Dose-Finding Clinical Trials: The CONSORT Dose-Finding Extension (CONSORT-DEFINE) Guidance

Abstract

Bibliographical note

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