Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance - Inria - Institut national de recherche en sciences et technologies du numérique Access content directly
Journal Articles BMJ - British Medical Journal Year : 2023

Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance

Christina Yap (1) , Jan Rekowski (1) , Moreno Ursino (2, 3) , Olga Solovyeva (1) , Dhrusti Patel (1) , Munyaradzi Dimairo (4) , Christopher Weir (5) , An-Wen Chan (6) , Thomas Jaki (7) , Adrian Mander (8) , Thomas Evans (9) , Richard Peck (10) , Kathryn Hayward (11) , Melanie Calvert (12) , Khadija Rerhou Rantell (13) , Shing Lee (14) , Andrew Kightley (15) , Sally Hopewell (16) , Deborah Ashby (17) , Elizabeth Garrett-Mayer (18) , John Isaacs (19) , Robert Golub (20) , Olga Kholmanskikh (21) , Dawn Richards (22) , Oliver Boix (23) , James Matcham (24) , Lesley Seymour (23) , S Percy Ivy (25) , Lynley Marshall (1) , Antoine Hommais (26) , Rong Liu (27) , Yoshiya Tanaka (28) , Jordan Berlin (29) , Aude Espinasse (1) , Johann de Bono (1, 30)
1 The institute of cancer research [London]
2 CRC (UMR_S_1138 / U1138) - Centre de Recherche des Cordeliers
3 HeKA - Health data- and model- driven Knowledge Acquisition
4 University of Sheffield [Sheffield]
5 Edin. - University of Edinburgh
6 University of Toronto
7 CAM - University of Cambridge [UK]
8 Cardiff University
9 University of Glasgow
10 University of Liverpool
11 University of Melbourne
12 University of Birmingham [Birmingham]
13 MHRA - Medicines and Healthcare Products Regulatory Agency
14 Columbia University [New York]
15 PPIE - Patient and public involvement and engagement lead [Lichfield]
16 University of Oxford
17 St Mary's Hospital [London]
18 American Society of Clinical Oncology [Alexandria, VA]
19 Newcastle University [Newcastle]
20 Feinberg School of Medicine
21 FAMPH - Federal Agency for Medicines and Health Products
22 Clinical Trials Ontario
23 Queen's University [Kingston, Canada]
24 Cytel [Perth]
25 NIH - National Institutes of Health [Bethesda, MD, USA]
26 INCa - Institut national du cancer
27 Bristol-Myers Squibb Company
28 UEOH - University of Occupational and Environmental Health [Kitakyushu]
29 VICC - Vanderbilt-Ingram Cancer Center
30 The Royal Marsden NHS Foundation Trust [London]
Christina Yap
The institute of cancer research [London]
Jan Rekowski
The institute of cancer research [London]
Moreno Ursino
Centre de Recherche des Cordeliers
Health data- and model- driven Knowledge Acquisition
Olga Solovyeva
The institute of cancer research [London]
Dhrusti Patel
The institute of cancer research [London]
Munyaradzi Dimairo
University of Sheffield [Sheffield]
Christopher Weir
University of Edinburgh
An-Wen Chan
  • Function : Author
University of Toronto
Thomas Jaki
University of Cambridge [UK]
Adrian Mander
Cardiff University
Thomas Evans
University of Glasgow
Richard Peck
University of Liverpool
Kathryn Hayward
University of Melbourne
Melanie Calvert
University of Birmingham [Birmingham]
Khadija Rerhou Rantell
Medicines and Healthcare Products Regulatory Agency
Shing Lee
  • Function : Author
Columbia University [New York]
Andrew Kightley
Patient and public involvement and engagement lead [Lichfield]
Sally Hopewell
University of Oxford
Deborah Ashby
St Mary's Hospital [London]
Elizabeth Garrett-Mayer
American Society of Clinical Oncology [Alexandria, VA]
John Isaacs
Newcastle University [Newcastle]
Robert Golub
  • Function : Author
Feinberg School of Medicine
Olga Kholmanskikh
  • Function : Author
Federal Agency for Medicines and Health Products
Dawn Richards
Clinical Trials Ontario
Oliver Boix
  • Function : Author
Queen's University [Kingston, Canada]
James Matcham
  • Function : Author
Cytel [Perth]
Lesley Seymour
Queen's University [Kingston, Canada]
S Percy Ivy
National Institutes of Health [Bethesda, MD, USA]
Lynley Marshall
The institute of cancer research [London]
Antoine Hommais
  • Function : Author
Institut national du cancer
Rong Liu
  • Function : Author
Bristol-Myers Squibb Company
Yoshiya Tanaka
University of Occupational and Environmental Health [Kitakyushu]
Jordan Berlin
Vanderbilt-Ingram Cancer Center
Aude Espinasse
The institute of cancer research [London]
Johann de Bono
The institute of cancer research [London]
The Royal Marsden NHS Foundation Trust [London]

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Humanities and Social Sciences

Moreno Ursino  : Connect in order to contact the contributor

https://hal.science/hal-04336820

Submitted on : Monday, December 11, 2023-10:31:13 PM

Last modification on : Thursday, April 25, 2024-11:00:02 PM

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hal-04336820 , version 1 (11-12-2023)

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Christina Yap, Jan Rekowski, Moreno Ursino, Olga Solovyeva, Dhrusti Patel, et al.. Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance. BMJ - British Medical Journal, In press, pp.e076386. ⟨10.1136/bmj-2023-076386⟩. ⟨hal-04336820⟩

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