Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance
Christina Yap
(1)
,
Olga Solovyeva
(1)
,
Johann de Bono
(1)
,
Jan Rekowski
(1)
,
Dhrusti Patel
(1)
,
Thomas Jaki
(2)
,
Adrian Mander
(3)
,
Thomas Evans
(4)
,
Richard Peck
(5)
,
Kathryn Hayward
(6)
,
Sally Hopewell
(7)
,
Moreno Ursino
(8, 9)
,
Khadija Rerhou Rantell
(10)
,
Melanie Calvert
(11)
,
Shing Lee
(12)
,
Andrew Kightley
(13)
,
Deborah Ashby
(14)
,
An-Wen Chan
(15)
,
Elizabeth Garrett-Mayer
(16)
,
John Isaacs
(17)
,
Robert Golub
(18)
,
Olga Kholmanskikh
(19)
,
Dawn Richards
(20)
,
Oliver Boix
(21)
,
James Matcham
(22)
,
Lesley Seymour
(23)
,
S Percy Ivy
(24)
,
Lynley Marshall
(1)
,
Antoine Hommais
(25)
,
Rong Liu
(26)
,
Yoshiya Tanaka
(27)
,
Jordan Berlin
(28)
,
Aude Espinasse
(1)
,
Munyaradzi Dimairo
(29)
,
Christopher Weir
(30)
1
The institute of cancer research [London]
2 CAM - University of Cambridge [UK]
3 Cardiff University
4 University of Glasgow
5 University of Liverpool
6 University of Melbourne
7 University of Oxford
8 CRC (UMR_S_1138 / U1138) - Centre de Recherche des Cordeliers
9 HeKA - Health data- and model- driven Knowledge Acquisition
10 MHRA - Medicines and Healthcare Products Regulatory Agency
11 University of Birmingham [Birmingham]
12 Columbia University [New York]
13 PPIE - Patient and public involvement and engagement lead [Lichfield]
14 Imperial College London
15 University of Toronto
16 American Society of Clinical Oncology [Alexandria, VA]
17 Newcastle University [Newcastle]
18 Feinberg School of Medicine
19 FAMPH - Federal Agency for Medicines and Health Products
20 Clinical Trials Ontario
21 Bayer Pharma AG [Berlin]
22 Cytel [Perth]
23 Queen's University [Kingston, Canada]
24 NIH - National Institutes of Health [Bethesda, MD, USA]
25 INCa - Institut national du cancer
26 Bristol-Myers Squibb Company
27 UEOH - University of Occupational and Environmental Health [Kitakyushu]
28 VICC - Vanderbilt-Ingram Cancer Center
29 University of Sheffield [Sheffield]
30 Edin. - University of Edinburgh
2 CAM - University of Cambridge [UK]
3 Cardiff University
4 University of Glasgow
5 University of Liverpool
6 University of Melbourne
7 University of Oxford
8 CRC (UMR_S_1138 / U1138) - Centre de Recherche des Cordeliers
9 HeKA - Health data- and model- driven Knowledge Acquisition
10 MHRA - Medicines and Healthcare Products Regulatory Agency
11 University of Birmingham [Birmingham]
12 Columbia University [New York]
13 PPIE - Patient and public involvement and engagement lead [Lichfield]
14 Imperial College London
15 University of Toronto
16 American Society of Clinical Oncology [Alexandria, VA]
17 Newcastle University [Newcastle]
18 Feinberg School of Medicine
19 FAMPH - Federal Agency for Medicines and Health Products
20 Clinical Trials Ontario
21 Bayer Pharma AG [Berlin]
22 Cytel [Perth]
23 Queen's University [Kingston, Canada]
24 NIH - National Institutes of Health [Bethesda, MD, USA]
25 INCa - Institut national du cancer
26 Bristol-Myers Squibb Company
27 UEOH - University of Occupational and Environmental Health [Kitakyushu]
28 VICC - Vanderbilt-Ingram Cancer Center
29 University of Sheffield [Sheffield]
30 Edin. - University of Edinburgh
Christina Yap
- Fonction : Auteur
- PersonId : 1322647
- ORCID : 0000-0002-6715-2514
Olga Solovyeva
- Fonction : Auteur
- PersonId : 1322636
- ORCID : 0000-0001-7828-4099
Johann de Bono
- Fonction : Auteur
- PersonId : 821128
- ORCID : 0000-0002-2034-595X
Jan Rekowski
- Fonction : Auteur
- PersonId : 1322648
- ORCID : 0000-0002-5207-3864
Dhrusti Patel
- Fonction : Auteur
- PersonId : 1322640
- ORCID : 0009-0001-4113-2726
Thomas Jaki
- Fonction : Auteur
- PersonId : 803185
- ORCID : 0000-0002-1096-188X
Richard Peck
- Fonction : Auteur
- PersonId : 1322649
- ORCID : 0000-0003-1018-9655
Kathryn Hayward
- Fonction : Auteur
- PersonId : 1322650
- ORCID : 0000-0001-5240-3264
Sally Hopewell
- Fonction : Auteur
- PersonId : 1322644
- ORCID : 0000-0002-6881-6984
Moreno Ursino
- Fonction : Auteur
- PersonId : 1029557
- IdHAL : moreno-ursino
Khadija Rerhou Rantell
- Fonction : Auteur
- PersonId : 1322645
- ORCID : 0000-0002-6747-7650
Melanie Calvert
- Fonction : Auteur
- PersonId : 1322651
- ORCID : 0000-0002-1856-837X
Andrew Kightley
- Fonction : Auteur
- PersonId : 1322641
- ORCID : 0000-0002-5228-3255
Deborah Ashby
- Fonction : Auteur
- PersonId : 1322652
- ORCID : 0000-0003-3146-7466
Elizabeth Garrett-Mayer
- Fonction : Auteur
- PersonId : 1322653
- ORCID : 0000-0003-4709-0333
John Isaacs
- Fonction : Auteur
- PersonId : 1322654
- ORCID : 0000-0002-6103-7056
Dawn Richards
- Fonction : Auteur
- PersonId : 1322646
- ORCID : 0000-0003-1151-0826
Lesley Seymour
- Fonction : Auteur
- PersonId : 1322655
- ORCID : 0000-0001-8081-0799
S Percy Ivy
- Fonction : Auteur
- PersonId : 1322656
- ORCID : 0000-0001-7747-072X
Lynley Marshall
- Fonction : Auteur
- PersonId : 1322657
- ORCID : 0000-0002-6537-2118
Yoshiya Tanaka
- Fonction : Auteur
- PersonId : 825739
- ORCID : 0000-0002-0807-7139
Jordan Berlin
- Fonction : Auteur
- PersonId : 1322658
- ORCID : 0000-0001-7571-2385
Aude Espinasse
- Fonction : Auteur
- PersonId : 1322639
- ORCID : 0000-0002-1271-302X
Munyaradzi Dimairo
- Fonction : Auteur
- PersonId : 1322637
- ORCID : 0000-0002-9311-6920
Christopher Weir
- Fonction : Auteur
- PersonId : 1322638
- ORCID : 0000-0002-6494-4903
Résumé
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.