Abstract
Research Methods & Reporting
Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance
BMJ 2023; 383 doi: https://doi.org/10.1136/bmj-2023-076386 (Published 20 October 2023)
Cite this as: BMJ 2023;383:e076386
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Enhancing reporting quality and impact of early phase dose-finding clinical trials
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Christina Yap, professor of clinical trials biostatistics1, Jan Rekowski, principal statistician1, Moreno Ursino, research fellow and associate professor2 3 4 5, Olga Solovyeva, trial methodologist1, Dhrusti Patel, research assistant1, Munyaradzi Dimairo, senior research fellow6, Christopher J Weir, professor of medical statistics and clinical trials7, An-Wen Chan, Phelan senior scientist8, Thomas Jaki, professor of statistics and chair for computational statistics9 10, Adrian Mander, professor of medical statistics11, Thomas R Jeffry Evans, clinical director12, Richard Peck, honorary professor and global head of clinical pharmacology13 14, Kathryn S Hayward, associate professor and senior research fellow15 16, Melanie Calvert, director and centre director and academic lead17 18 19 20 21, Khadija Rerhou Rantell, senior statistical adviser22, Shing Lee, associate professor of biostatistics23, Andrew Kightley, patient and public involvement and engagement lead24, Sally Hopewell, professor of clinical trials and evidence synthesis25, Deborah Ashby, professor of medical statistics and clinical trials26, Elizabeth Garrett-Mayer, vice president27, John Isaacs, professor of clinical rheumatology and honorary consultant rheumatologist28 29, Robert Golub, professor of medicine (general internal medicine) and preventive medicine30, Olga Kholmanskikh, clinical assessor and oncology working party member31, Dawn P Richards, director of patient and public engagement32, Oliver Boix, expert statistician oncology early clinical development33, James Matcham, vice president34, Lesley Seymour, director35, S Percy Ivy, associate branch chief36, Lynley V Marshall, honorary appointment and consultant1 37, Antoine Hommais, project manager38, Rong Liu, senior director of biostatistics39, Yoshiya Tanaka, professor and chairman40, Jordan Berlin, associate director for clinical research41, Aude Espinasse, clinical trials programme manager1, Johann de Bono, regius professor of cancer research and professor in experimental cancer medicine1 37
Author affiliations
Correspondence to: C Yap [email protected]
Accepted 5 August 2023
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care.
Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance
BMJ 2023; 383 doi: https://doi.org/10.1136/bmj-2023-076386 (Published 20 October 2023)
Cite this as: BMJ 2023;383:e076386
Linked Research Methods & Reporting
Enhancing reporting quality and impact of early phase dose-finding clinical trials
Article
Related content
Metrics
Responses
Peer review
Christina Yap, professor of clinical trials biostatistics1, Jan Rekowski, principal statistician1, Moreno Ursino, research fellow and associate professor2 3 4 5, Olga Solovyeva, trial methodologist1, Dhrusti Patel, research assistant1, Munyaradzi Dimairo, senior research fellow6, Christopher J Weir, professor of medical statistics and clinical trials7, An-Wen Chan, Phelan senior scientist8, Thomas Jaki, professor of statistics and chair for computational statistics9 10, Adrian Mander, professor of medical statistics11, Thomas R Jeffry Evans, clinical director12, Richard Peck, honorary professor and global head of clinical pharmacology13 14, Kathryn S Hayward, associate professor and senior research fellow15 16, Melanie Calvert, director and centre director and academic lead17 18 19 20 21, Khadija Rerhou Rantell, senior statistical adviser22, Shing Lee, associate professor of biostatistics23, Andrew Kightley, patient and public involvement and engagement lead24, Sally Hopewell, professor of clinical trials and evidence synthesis25, Deborah Ashby, professor of medical statistics and clinical trials26, Elizabeth Garrett-Mayer, vice president27, John Isaacs, professor of clinical rheumatology and honorary consultant rheumatologist28 29, Robert Golub, professor of medicine (general internal medicine) and preventive medicine30, Olga Kholmanskikh, clinical assessor and oncology working party member31, Dawn P Richards, director of patient and public engagement32, Oliver Boix, expert statistician oncology early clinical development33, James Matcham, vice president34, Lesley Seymour, director35, S Percy Ivy, associate branch chief36, Lynley V Marshall, honorary appointment and consultant1 37, Antoine Hommais, project manager38, Rong Liu, senior director of biostatistics39, Yoshiya Tanaka, professor and chairman40, Jordan Berlin, associate director for clinical research41, Aude Espinasse, clinical trials programme manager1, Johann de Bono, regius professor of cancer research and professor in experimental cancer medicine1 37
Author affiliations
Correspondence to: C Yap [email protected]
Accepted 5 August 2023
SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 provides guidance for clinical trial protocol writing. However, neither the original guidance nor its extensions adequately cover the features of early phase dose-finding trials. The SPIRIT Dose-finding Extension (DEFINE) statement is a new guideline that provides recommendations for essential items that should be provided in the protocols of these trials. It details extensions to the SPIRIT 2013 guidance, incorporating 17 new items and modifying 15 existing items. The purpose of this guideline is to promote transparency, completeness, reproducibility of methods, and interpretation of early phase dose-finding trial protocols. It is envisioned that the resulting improvements in the design and conduct of early phase clinical trials will ultimately reduce research inefficiencies and inconsistencies, driving transformational advances in clinical care.
| Original language | English |
|---|---|
| Article number | e076386 |
| Number of pages | 14 |
| Journal | BMJ |
| Volume | 383 |
| DOIs | |
| Publication status | Published - 20 Oct 2023 |