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Adaptive designs for phase II oncology trials

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Adaptive designs for phase II oncology trials. / Kieser, Meinhard; Englert, Stefan; Rauch, Geraldine.

In: J BIOPHARM STAT, Vol. 5, No. 4, 2015, p. 363–366.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Kieser, M, Englert, S & Rauch, G 2015, 'Adaptive designs for phase II oncology trials', J BIOPHARM STAT, vol. 5, no. 4, pp. 363–366. <http://www.openaccessjournals.com/articles/adaptive-designs-for-phase-ii-oncology-trials.pdf>

APA

Kieser, M., Englert, S., & Rauch, G. (2015). Adaptive designs for phase II oncology trials. J BIOPHARM STAT, 5(4), 363–366. http://www.openaccessjournals.com/articles/adaptive-designs-for-phase-ii-oncology-trials.pdf

Vancouver

Kieser M, Englert S, Rauch G. Adaptive designs for phase II oncology trials. J BIOPHARM STAT. 2015;5(4):363–366.

Bibtex

@article{efbc28e8184e458a899e9672148950db,
title = "Adaptive designs for phase II oncology trials",
abstract = "When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to specify an interval for the possible true rate to accommodate this uncertainty. For this situation, we examine comprehensively the overall performance of various Phase II oncology designs and sample size recalculation strategies. The methods and results of our investigations can be used to identify the most appropriate approach for a specific clinical trial situation at hand. Application is illustrated with a clinical trial in rectal cancer.",
keywords = "Clinical Trials, Phase II as Topic, Disease-Free Survival, Endpoint Determination, Humans, Medical Oncology, Randomized Controlled Trials as Topic, Rectal Neoplasms, Research Design, Sample Size, Journal Article, Research Support, Non-U.S. Gov't",
author = "Meinhard Kieser and Stefan Englert and Geraldine Rauch",
year = "2015",
language = "English",
volume = "5",
pages = "363–366",
journal = "J BIOPHARM STAT",
issn = "1054-3406",
publisher = "Taylor & Francis",
number = "4",

}

RIS

TY - JOUR

T1 - Adaptive designs for phase II oncology trials

AU - Kieser, Meinhard

AU - Englert, Stefan

AU - Rauch, Geraldine

PY - 2015

Y1 - 2015

N2 - When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to specify an interval for the possible true rate to accommodate this uncertainty. For this situation, we examine comprehensively the overall performance of various Phase II oncology designs and sample size recalculation strategies. The methods and results of our investigations can be used to identify the most appropriate approach for a specific clinical trial situation at hand. Application is illustrated with a clinical trial in rectal cancer.

AB - When planning a single-armed clinical trial with binary endpoint, the sample size is determined such that the desired power is achieved for a single value of the target rate. However, there is usually some uncertainty with respect to the true treatment effect. It is therefore more realistic to specify an interval for the possible true rate to accommodate this uncertainty. For this situation, we examine comprehensively the overall performance of various Phase II oncology designs and sample size recalculation strategies. The methods and results of our investigations can be used to identify the most appropriate approach for a specific clinical trial situation at hand. Application is illustrated with a clinical trial in rectal cancer.

KW - Clinical Trials, Phase II as Topic

KW - Disease-Free Survival

KW - Endpoint Determination

KW - Humans

KW - Medical Oncology

KW - Randomized Controlled Trials as Topic

KW - Rectal Neoplasms

KW - Research Design

KW - Sample Size

KW - Journal Article

KW - Research Support, Non-U.S. Gov't

M3 - SCORING: Journal article

C2 - 24905363

VL - 5

SP - 363

EP - 366

JO - J BIOPHARM STAT

JF - J BIOPHARM STAT

SN - 1054-3406

IS - 4

ER -