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020 ▼a 9780438191600
035 ▼a (MiAaPQ)AAI10907758
040 ▼a MiAaPQ ▼c MiAaPQ ▼d 248032
0820 ▼a 574
1001 ▼a DeVeaux, Michelle Lynn.
24510 ▼a Innovative Statistical Methods for Early Phase Clinical Trials.
260 ▼a [S.l.] : ▼b Yale University., ▼c 2018
260 1 ▼a Ann Arbor : ▼b ProQuest Dissertations & Theses, ▼c 2018
300 ▼a 129 p.
500 ▼a Source: Dissertation Abstracts International, Volume: 79-11(E), Section: B.
500 ▼a Adviser: Daniel Zelterman.
5021 ▼a Thesis (Ph.D.)--Yale University, 2018.
520 ▼a Early phase clinical trials provide some of the first indications of the efficacy of the experimental therapy at treating a disease. Often, the endpoint chosen to evaluate the treatment efficacy requires a lengthy follow-up time on each patient,
520 ▼a We propose a two-stage design for a single-arm clinical trial with an early stopping rule for futility. Unlike Simon's design, our proposed design employs different criteria to assess early stopping and efficacy. The early stopping rule is based
520 ▼a Curtailed sampling rules are introduced into this clinical trial design to allow the study to end as soon as a predefined statistical endpoint is reached. This helps to reduce the required number of patient enrollees and the expected duration of
520 ▼a We also have developed an R package which provides tools to assist in the planning of this two-stage nested clinical trial design as well as the single-stage design with curtailed sampling. Visualization tools are provided to aid in selecting a
520 ▼a The proposed two-stage nested design has the potential to substantially reduce the duration of these types of clinical trials, which is a significant factor in lowering clinical trial costs. Additionally, alleviating the length of the problemati
590 ▼a School code: 0265.
650 4 ▼a Biostatistics.
650 4 ▼a Statistics.
650 4 ▼a Oncology.
690 ▼a 0308
690 ▼a 0463
690 ▼a 0992
71020 ▼a Yale University.
7730 ▼t Dissertation Abstracts International ▼g 79-11B(E).
773 ▼t Dissertation Abstract International
790 ▼a 0265
791 ▼a Ph.D.
792 ▼a 2018
793 ▼a English
85640 ▼u http://www.riss.kr/pdu/ddodLink.do?id=T15000809 ▼n KERIS
980 ▼a 201812 ▼f 2019
990 ▼a 관리자