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Oncology phase I trial design and conduct: time for a change - MDICT Guidelines 2022.
Araujo D, Greystoke A, Bates S, Bayle A, Calvo E, Castelo-Branco L, de Bono J, Drilon A, Garralda E, Ivy P, Kholmanskikh O, Melero I, Pentheroudakis G, Petrie J, Plummer R, Ponce S, Postel-Vinay S, Siu L, Spreafico A, Stathis A, Steeghs N, Yap C, Yap TA, Ratain M, Seymour L. Araujo D, et al. Among authors: kholmanskikh o. Ann Oncol. 2023 Jan;34(1):48-60. doi: 10.1016/j.annonc.2022.09.158. Epub 2022 Sep 29. Ann Oncol. 2023. PMID: 36182023 Free article. Review.
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. Among authors: kholmanskikh o. BMJ. 2023 Oct 20;383:e076386. doi: 10.1136/bmj-2023-076386. BMJ. 2023. PMID: 37863491 No abstract available.
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. Among authors: kholmanskikh o. BMJ. 2023 Oct 20;383:e076387. doi: 10.1136/bmj-2023-076387. BMJ. 2023. PMID: 37863501 Free PMC article.
EMA Review of Axicabtagene Ciloleucel (Yescarta) for the Treatment of Diffuse Large B-Cell Lymphoma.
Papadouli I, Mueller-Berghaus J, Beuneu C, Ali S, Hofner B, Petavy F, Tzogani K, Miermont A, Norga K, Kholmanskikh O, Leest T, Schuessler-Lenz M, Salmonson T, Gisselbrecht C, Garcia JL, Pignatti F. Papadouli I, et al. Among authors: kholmanskikh o. Oncologist. 2020 Oct;25(10):894-902. doi: 10.1634/theoncologist.2019-0646. Epub 2020 Apr 27. Oncologist. 2020. PMID: 32339368 Free PMC article. Review.