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

Christina Yap; Jan Rekowski; Moreno Ursino; Olga Solovyeva; Dhrusti Patel; Munyaradzi Dimairo; Christopher J Weir; An-Wen Chan; Thomas Jaki; Adrian Mander; Thomas R Jeffry Evans; Richard Peck; Kathryn S Hayward; Melanie Calvert; Khadija Rerhou Rantell; Shing Lee; Andrew Kightley; Sally Hopewell; Deborah Ashby; Elizabeth Garrett-Mayer; John 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; Johann de Bono

doi:10.1136/bmj-2023-076386

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

Christina Yap^*, Jan Rekowski, Moreno Ursino, Olga Solovyeva, Dhrusti Patel, Munyaradzi Dimairo, Christopher J Weir, An-Wen Chan, Thomas Jaki, Adrian Mander, Thomas R Jeffry Evans, Richard Peck, Kathryn S Hayward, Melanie Calvert, Khadija Rerhou Rantell, Shing Lee, Andrew Kightley, Sally Hopewell, Deborah Ashby, Elizabeth Garrett-MayerJohn 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, Johann de Bono

^*Corresponding author for this work

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

Original language	English
Article number	e076386
Number of pages	14
Journal	BMJ (Clinical Research ed.)
Volume	383
DOIs	https://doi.org/10.1136/bmj-2023-076386
Publication status	Published - 20 Oct 2023

Access to Document

10.1136/bmj-2023-076386

BMJ SPIRIT-DEFINE Statement_R1_AcceptedVersionAccepted author manuscript, 453 KBLicence: Creative Commons: Attribution (CC-BY)

Cite this

Yap, C., Rekowski, J., Ursino, M., Solovyeva, O., Patel, D., Dimairo, M., Weir, C. J., Chan, A.-W., Jaki, T., Mander, A., Evans, T. R. J., Peck, R., Hayward, K. S., Calvert, M., Rantell, K. R., Lee, S., Kightley, A., Hopewell, S., Ashby, D., ... de Bono, J. (2023). Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance. BMJ (Clinical Research ed.), 383, Article e076386. https://doi.org/10.1136/bmj-2023-076386

@article{a99ef38be1254ac4aa08086f9dfd75e7,

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

author = "Christina Yap and Jan Rekowski and Moreno Ursino and Olga Solovyeva and Dhrusti Patel and Munyaradzi Dimairo and Weir, {Christopher J} and An-Wen Chan and Thomas Jaki and Adrian Mander and Evans, {Thomas R Jeffry} and Richard Peck and Hayward, {Kathryn S} and Melanie Calvert and Rantell, {Khadija Rerhou} and Shing Lee and Andrew Kightley and Sally Hopewell and Deborah Ashby and Elizabeth Garrett-Mayer and John Isaacs 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 {de Bono}, Johann",

note = "The SPIRIT-DEFINE study obtained no external funding. The principal investigator (CY) used internal staff resources, together with additional resources from external partners, to conduct this study. The SPIRIT-DEFINE study is a component of the DEFINE project, which also developed the MRC/NIHR funded CONSORT-DEFINE guidance. 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 UK Medical Research Council (MC_UU_00002/14). DA acknowledges support from the National Institute for Health and Care Research (NIHR) Imperial Biomedical Research Centre. KSH received funding from the National Health and Medical Research Council of Australia (grants 2016420, 2015705) and acknowledges support from the Heart Foundation of Australia (grant 106607). LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and acknowledges further funding support from the UK{\textquoteright}s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Biomedical Research Centre. JdB received programmatic funding support from Cancer Research UK and the UK NIHR, who together support the Experimental Cancer Medicine Centre at the Royal Marsden and ICR, as well as from the Medical Research Council. 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 the views of the authors, the Delphi participants, and the Consensus Meeting participants, and may not represent the views of the broader stakeholder groups, the authors{\textquoteright} institutions, or other affiliations.",

year = "2023",

month = oct,

day = "20",

doi = "10.1136/bmj-2023-076386",

language = "English",

volume = "383",

journal = "BMJ (Clinical Research ed.)",

issn = "0959-8138",

publisher = "BMJ Publishing Group",

}

Yap, C, Rekowski, J, Ursino, M, Solovyeva, O, Patel, D, Dimairo, M, Weir, CJ, Chan, A-W, Jaki, T, Mander, A, Evans, TRJ, Peck, R, Hayward, KS, Calvert, M, Rantell, KR, Lee, S, Kightley, A, Hopewell, S, Ashby, D, Garrett-Mayer, E, Isaacs, J, 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 & de Bono, J 2023, 'Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance', BMJ (Clinical Research ed.), vol. 383, e076386. https://doi.org/10.1136/bmj-2023-076386

TY - JOUR

T1 - Enhancing quality and impact of early phase dose-finding clinical trial protocols

T2 - SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance

AU - Yap, Christina

AU - Rekowski, Jan

AU - Ursino, Moreno

AU - Solovyeva, Olga

AU - Patel, Dhrusti

AU - Dimairo, Munyaradzi

AU - Weir, Christopher J

AU - Chan, An-Wen

AU - Jaki, Thomas

AU - Mander, Adrian

AU - Evans, Thomas R Jeffry

AU - Peck, Richard

AU - Hayward, Kathryn S

AU - Calvert, Melanie

AU - Rantell, Khadija Rerhou

AU - Lee, Shing

AU - Kightley, Andrew

AU - Hopewell, Sally

AU - Ashby, Deborah

AU - Garrett-Mayer, Elizabeth

AU - Isaacs, John

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 - de Bono, Johann

N1 - The SPIRIT-DEFINE study obtained no external funding. The principal investigator (CY) used internal staff resources, together with additional resources from external partners, to conduct this study. The SPIRIT-DEFINE study is a component of the DEFINE project, which also developed the MRC/NIHR funded CONSORT-DEFINE guidance. 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 UK Medical Research Council (MC_UU_00002/14). DA acknowledges support from the National Institute for Health and Care Research (NIHR) Imperial Biomedical Research Centre. KSH received funding from the National Health and Medical Research Council of Australia (grants 2016420, 2015705) and acknowledges support from the Heart Foundation of Australia (grant 106607). LVM is funded by the Oak Foundation via the Royal Marsden Cancer Charity and acknowledges further funding support from the UK’s Experimental Cancer Medicines Centre Paediatric Network grant and the NIHR Royal Marsden/Institute of Cancer Biomedical Research Centre. JdB received programmatic funding support from Cancer Research UK and the UK NIHR, who together support the Experimental Cancer Medicine Centre at the Royal Marsden and ICR, as well as from the Medical Research Council. 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 the views of the authors, the Delphi participants, and the Consensus Meeting participants, and may not represent the views of the broader stakeholder groups, the authors’ institutions, or other affiliations.

PY - 2023/10/20

Y1 - 2023/10/20

U2 - 10.1136/bmj-2023-076386

DO - 10.1136/bmj-2023-076386

M3 - Article

C2 - 37863491

SN - 0959-8138

VL - 383

JO - BMJ (Clinical Research ed.)

JF - BMJ (Clinical Research ed.)

M1 - e076386

ER -