Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review

Autor: Villacampa, Guillermo, Patel, Dhrusti, Zheng, Haiyan, McAleese, Jessica, Rekowski, Jan, Solovyeva, Olga, Yin, Zhulin, Yap, Christina

Publikováno v: In eClinicalMedicine June 2023 60

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Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials:the DEFINE study

Autor: Solovyeva, Olga, Dimairo, Munyaradzi, Weir, Christopher J, Hee, Siew Wan, Espinasse, Aude, Ursino, Moreno, Patel, Dhrusti, Kightley, Andrew, Hughes, Sarah E, Jaki, Thomas, Mander, Adrian, Evans, Thomas Ronald Jeffry, Lee, Shing, Hopewell, Sally, Rantell, Khadija Rerhou, Chan, An-Wen, Bedding, Alun, Stephens, Richard, Richards, Dawn, Roberts, Lesley, Kirkpatrick, John, deBono, Johann, Yap, Christina

Publikováno v: Solovyeva, O, Dimairo, M, Weir, C J, Hee, S W, Espinasse, A, Ursino, M, Patel, D, Kightley, A, Hughes, S E, Jaki, T, Mander, A, Evans, T R J, Lee, S, Hopewell, S, Rantell, K R, Chan, A-W, Bedding, A, Stephens, R, Richards, D, Roberts, L, Kirkpatrick, J, deBono, J & Yap, C 2023, ' Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials : the DEFINE study ', BMC Medicine, vol. 21, 246 . https://doi.org/10.1186/s12916-023-02937-0

BackgroundEarly phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and completed trial reports in the

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=od______3094::8e5abb5a1745cff44b6253aec0dd9c81
https://www.pure.ed.ac.uk/ws/files/363334036/s12916_023_02937_0.pdf

Development process of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE (DosE FIndiNg Extensions) study

Autor: Mander, Adrian, Dimairo, Munya, Richards, Dawn, Evans, Jeff, Ursino, Moreno, De Bono, Johann, Hughes, Sarah, Stephens, Richard, Hee, Siew, Roberts, Lesley, Hopewell, Sally, Kirkpatrick, John, Yap, Christina, Bedding, Alun, Rantell, Khadija, Kightley, Andrew, Weir, Christopher, Jaki, Thomas, Patel, Dhrusti, Espinasse, Aude, Solovyeva, Olga, Lee, Shing, Chan, An-Wen

BACKGROUND Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and completed trial reports in the

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::85a55a7ac20c2647af0ce7b2f043543c
https://doi.org/10.31222/osf.io/jtpz2