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Early Clinical Trial Design Recommendations in Oncology Based on Overall Success across Phases I, II, and III

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서명/저자사항Early Clinical Trial Design Recommendations in Oncology Based on Overall Success across Phases I, II, and III.
개인저자Ruppert Stark, Amy S.
단체저자명The Ohio State University. Biostatistics.
발행사항[S.l.]: The Ohio State University., 2017.
발행사항Ann Arbor: ProQuest Dissertations & Theses, 2017.
형태사항204 p.
기본자료 저록Dissertation Abstracts International 79-12B(E).
Dissertation Abstract International
ISBN9780438097766
학위논문주기Thesis (Ph.D.)--The Ohio State University, 2017.
일반주기 Source: Dissertation Abstracts International, Volume: 79-12(E), Section: B.
Adviser: Abigail Shoben.
요약Conventionally, drug development has spanned three distinct phases, and the success rate for experimental drugs across phases has been less than 15% (Hay, Thomas, Craighead, Economides, and Rosenthal, 2014). Despite increased options for nonstan
요약Phase I, II, and III trials were simulated for clinical scenarios defined by eight toxicity profiles and two nondecreasing efficacy profiles. Early results showed that correctly selecting the maximum tolerated dose (MTD) greatly impacted overall
요약Based on our results, we make the following recommendations for design selection when data informing the shape of the dose-toxicity curve exist. If a large jump in toxicity between dose levels is expected, we recommend the standard 3+3 design, w
일반주제명Biostatistics.
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