자료유형 | 학위논문 |
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서명/저자사항 | Innovative Statistical Methods for Early Phase Clinical Trials. |
개인저자 | DeVeaux, Michelle Lynn. |
단체저자명 | Yale University. |
발행사항 | [S.l.]: Yale University., 2018. |
발행사항 | Ann Arbor: ProQuest Dissertations & Theses, 2018. |
형태사항 | 129 p. |
기본자료 저록 | Dissertation Abstracts International 79-11B(E). Dissertation Abstract International |
ISBN | 9780438191600 |
학위논문주기 | Thesis (Ph.D.)--Yale University, 2018. |
일반주기 |
Source: Dissertation Abstracts International, Volume: 79-11(E), Section: B.
Adviser: Daniel Zelterman. |
요약 | 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, |
요약 | 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 |
요약 | 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 |
요약 | 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 |
요약 | 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 |
일반주제명 | Biostatistics. Statistics. Oncology. |
언어 | 영어 |
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