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CBER's Experience With Adaptive Design Clinical Trials.
Lin M, Lee S, Zhen B, Scott J, Horne A, Solomon G, Russek-Cohen E. Lin M, et al. Among authors: scott j. Ther Innov Regul Sci. 2016 Mar;50(2):195-203. doi: 10.1177/2168479015604181. Ther Innov Regul Sci. 2016. PMID: 30227002
Bayesian Methods in Human Drug and Biological Products Development in CDER and CBER.
Ionan AC, Clark J, Travis J, Amatya A, Scott J, Smith JP, Chattopadhyay S, Salerno MJ, Rothmann M. Ionan AC, et al. Among authors: scott j. Ther Innov Regul Sci. 2023 May;57(3):436-444. doi: 10.1007/s43441-022-00483-0. Epub 2022 Dec 2. Ther Innov Regul Sci. 2023. PMID: 36459346 Free PMC article. Review.
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo M, Pallmann P, Wason J, Todd S, Jaki T, Julious SA, Mander AP, Weir CJ, Koenig F, Walton MK, Nicholl JP, Coates E, Biggs K, Hamasaki T, Proschan MA, Scott JA, Ando Y, Hind D, Altman DG; ACE Consensus Group. Dimairo M, et al. Among authors: scott ja. Trials. 2020 Jun 17;21(1):528. doi: 10.1186/s13063-020-04334-x. Trials. 2020. PMID: 32546273 Free PMC article.
Decision support environment for medical product safety surveillance.
Botsis T, Jankosky C, Arya D, Kreimeyer K, Foster M, Pandey A, Wang W, Zhang G, Forshee R, Goud R, Menschik D, Walderhaug M, Woo EJ, Scott J. Botsis T, et al. Among authors: scott j. J Biomed Inform. 2016 Dec;64:354-362. doi: 10.1016/j.jbi.2016.07.023. Epub 2016 Jul 28. J Biomed Inform. 2016. PMID: 27477839 Free article.
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