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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.
Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.
Hobbs BP, Barata PC, Kanjanapan Y, Paller CJ, Perlmutter J, Pond GR, Prowell TM, Rubin EH, Seymour LK, Wages NA, Yap TA, Feltquate D, Garrett-Mayer E, Grossman W, Hong DS, Ivy SP, Siu LL, Reeves SA, Rosner GL. Hobbs BP, et al. J Natl Cancer Inst. 2019 Feb 1;111(2):118-128. doi: 10.1093/jnci/djy196. J Natl Cancer Inst. 2019. PMID: 30561713 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.
American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes.
Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, Garrett-Mayer E, Herbst RS, Lilenbaum RC, Sima C, Venook AP, Gonen M, Schilsky RL, Meropol NJ, Schnipper LE. Ellis LM, et al. J Clin Oncol. 2014 Apr 20;32(12):1277-80. doi: 10.1200/JCO.2013.53.8009. Epub 2014 Mar 17. J Clin Oncol. 2014. PMID: 24638016 No abstract available.
Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality.
Unger JM, Stires H, Levit LA, Stewart M, McKelvey BA, Canin B, Dressler E, Flaherty K, Fredette P, Jones L, McCann P, Miller T, Onitilo AA, Palmieri F, Patel T, Paul R, Smith GL, Bruinooge SS, Garrett-Mayer E, Lei XJ, Alva A, Schenkel C. Unger JM, et al. JCO Oncol Pract. 2023 Oct;19(10):907-916. doi: 10.1200/OP.23.00185. Epub 2023 Aug 29. JCO Oncol Pract. 2023. PMID: 37643386 Free PMC article.
280 results