SPIRIT-DEFINE explanation and elaboration: recommendations for enhancing quality and impact of early phase dose-finding clinical trials protocols
This work is a further extension of the SPIRIT-DEFINE study, which 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; CTUQQR-Dec22/100004), which has contributed to accelerating the advancement and successful completion of this work.
Authors
- Moreno Ursino (ORCID: https://orcid.org/0000-0002-5709-4322)
- Christopher John Weir (ORCID: https://orcid.org/0000-0002-6494-4903)
- Munyaradzi Dimairo (ORCID: https://orcid.org/0000-0002-9311-6920)
- Mahtab Rouhifard (ORCID: https://orcid.org/0009-0006-6118-1097)
- Olga Solovyeva (ORCID: https://orcid.org/0000-0001-7828-4099)
- Yoshiya Tanaka (ORCID: https://orcid.org/0000-0002-0807-7139)
- Courtney H. Coschi
- Shing Yip Lee (ORCID: https://orcid.org/0000-0001-9336-2323)
- Christina Gertrude Yap (ORCID: https://orcid.org/0000-0002-6715-2514)
- Guillermo Villacampa (ORCID: https://orcid.org/0000-0003-4868-6585)
- Elizabeth Garrett‐Mayer (ORCID: https://orcid.org/0000-0003-4709-0333)
- Christina Guo (ORCID: https://orcid.org/0000-0002-1645-3202)
- Robert Golub (ORCID: https://orcid.org/0000-0001-7881-1207)
- Dawn P. Richards (ORCID: https://orcid.org/0000-0003-1151-0826)
- T.R. Jeffry Evans (ORCID: https://orcid.org/0000-0002-4175-914X)
- Adrian Mander (ORCID: https://orcid.org/0000-0002-0742-9040)
- Jordan Berlin (ORCID: https://orcid.org/0000-0001-7571-2385)
- Richard Peck (ORCID: https://orcid.org/0000-0003-1018-9655)
- Dhrusti Patel (ORCID: https://orcid.org/0009-0001-4113-2726)
- Lesley Seymour (ORCID: https://orcid.org/0000-0001-8081-0799)
- John D. Isaacs (ORCID: https://orcid.org/0000-0002-6103-7056)
- Sally Hopewell (ORCID: https://orcid.org/0000-0002-6881-6984)
- Jan Rekowski (ORCID: https://orcid.org/0000-0002-5207-3864)
- Thomas Jaki (ORCID: https://orcid.org/0000-0002-1096-188X)
- An‐Wen Chan (ORCID: https://orcid.org/0000-0002-4498-3382)
- Oliver Boix (ORCID: https://orcid.org/0000-0003-3704-0877)
- Khadija Rantell (ORCID: https://orcid.org/0000-0002-6747-7650)
- Johann Sebastian De Bono (ORCID: https://orcid.org/0000-0002-2034-595X)
- Melanie Calvert (ORCID: https://orcid.org/0000-0002-1856-837X)
- S. Percy Ivy (ORCID: https://orcid.org/0000-0001-7747-072X)
- Andrew Kightley (ORCID: https://orcid.org/0000-0002-5228-3255)
- Kathryn S. Hayward (ORCID: https://orcid.org/0000-0001-5240-3264)
- Lynley V. Marshall (ORCID: https://orcid.org/0000-0002-6537-2118)
- Olga Kholmanskikh (ORCID: https://orcid.org/0000-0002-9530-356X)
- Deborah Ashby (ORCID: https://orcid.org/0000-0003-3146-7466)
- Rong Liu (ORCID: https://orcid.org/0000-0003-2487-2121)
- James Matcham
Institutions
- Northwestern University (US)
- Roche (Switzerland) (CH)
- American Society of Clinical Oncology (US)
- Royal Marsden NHS Foundation Trust (GB)
- Institut national de recherche en sciences et technologies du numérique (FR)
- Institute of Cancer Research (GB)
- University of Liverpool (GB)
- Inserm (FR)
- The University of Melbourne (AU)
- University of Toronto (CA)
- Regeneron (United States) (US)
- University of Occupational and Environmental Health Japan (JP)
- Vanderbilt University (US)
- Université Paris Cité (FR)
- University of Cambridge (GB)
- Florey Institute of Neuroscience and Mental Health (AU)
- Newcastle upon Tyne Hospitals NHS Foundation Trust (GB)
- Women's College Hospital (CA)
- Freeman Hospital (GB)
- National Institute for Health and Care Research (GB)
- Sorbonne Université (FR)
- University of Oxford (GB)
- Centre de Recherche des Cordeliers (FR)
- Vall d'Hebron Institut de Recerca (ES)
- Robarts Clinical Trials (CA)
- St Mary's Hospital (GB)
- Hôpital Robert-Debré (FR)
- Advanced Innovative Engineering (United Kingdom) (GB)
- NIHR Newcastle Biomedical Research Centre (GB)
- MRC Biostatistics Unit (GB)
- Cancer Research UK Scotland Institute (GB)
- NIHR Birmingham Biomedical Research Centre (GB)
- French Clinical Research Infrastructure Network (FR)
- Vanderbilt-Ingram Cancer Center
- Imperial College London (GB)
- University of Regensburg (DE)
- Bayer (Germany) (DE)
- Columbia University (US)
- University of Glasgow (GB)
- Cardiff University (GB)
- University of Birmingham (GB)
- Newcastle University (GB)
- University of Sheffield (GB)
- Cytel (United States) (US)
- University of Edinburgh (GB)
Publication Details
- Journal
- EClinicalMedicine
- Published
- 2025-01-01
- DOI
- https://doi.org/10.1016/j.eclinm.2024.102988
- Citations
- 2
- Primary Topic
- Statistical Methods in Clinical Trials
- Type
- article
- Field-Weighted Citation Impact
- 5.26
Funders
- Cancer Research UK
- National Institute for Health and Care Research
- Medical Research Council