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Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.
Solovyeva O, Dimairo M, Weir CJ, Hee SW, Espinasse A, Ursino M, Patel D, Kightley A, Hughes S, Jaki T, Mander A, Evans TRJ, Lee S, Hopewell S, Rantell KR, Chan AW, Bedding A, Stephens R, Richards D, Roberts L, Kirkpatrick J, de Bono J, Yap C. Solovyeva O, et al. BMC Med. 2023 Jul 5;21(1):246. doi: 10.1186/s12916-023-02937-0. BMC Med. 2023. PMID: 37408015 Free PMC article. Review.
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
Yap C, Solovyeva O, de Bono J, Rekowski J, Patel D, Jaki T, Mander A, Evans TRJ, Peck R, Hayward KS, Hopewell S, Ursino M, Rantell KR, Calvert M, Lee S, Kightley A, Ashby D, Chan AW, Garrett-Mayer E, Isaacs JD, Golub R, Kholmanskikh O, Richards D, Boix O, Matcham J, Seymour L, Ivy SP, Marshall LV, Hommais A, Liu R, Tanaka Y, Berlin J, Espinasse A, Dimairo M, Weir CJ. Yap C, et al. BMJ. 2023 Oct 20;383:e076387. doi: 10.1136/bmj-2023-076387. BMJ. 2023. PMID: 37863501 Free PMC article.
Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.
Yap C, Rekowski J, Ursino M, Solovyeva O, Patel D, Dimairo M, Weir CJ, Chan AW, 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. Yap C, et al. BMJ. 2023 Oct 20;383:e076386. doi: 10.1136/bmj-2023-076386. BMJ. 2023. PMID: 37863491 No abstract available.