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The role of minimal sets in dose finding studies

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The role of minimal sets in dose finding studies. / Clertant, Matthieu; O'Quigley, John.

In: Journal of Nonparametric Statistics, Vol. 30, No. 4, 2018, p. 1016-1031.

Research output: Contribution to journalJournal articlepeer-review

Harvard

Clertant, M & O'Quigley, J 2018, 'The role of minimal sets in dose finding studies', Journal of Nonparametric Statistics, vol. 30, no. 4, pp. 1016-1031. https://doi.org/10.1080/10485252.2018.1515430

APA

Clertant, M., & O'Quigley, J. (2018). The role of minimal sets in dose finding studies. Journal of Nonparametric Statistics, 30(4), 1016-1031. https://doi.org/10.1080/10485252.2018.1515430

Vancouver

Clertant M, O'Quigley J. The role of minimal sets in dose finding studies. Journal of Nonparametric Statistics. 2018;30(4):1016-1031. https://doi.org/10.1080/10485252.2018.1515430

Author

Clertant, Matthieu ; O'Quigley, John. / The role of minimal sets in dose finding studies. In: Journal of Nonparametric Statistics. 2018 ; Vol. 30, No. 4. pp. 1016-1031.

Bibtex

@article{01409f9146914aba911ec76b496af621,
title = "The role of minimal sets in dose finding studies",
abstract = "In view of the impossibility theorem of Azriel et al., the Maximum Tolerated Dose (MTD), as currently defined in Phase I and Phase I/II trials, cannot be consistently estimated without making some very strong parametric assumptions. Experimentation carried out at a single dose will fail to provide a consistent estimator of the MTD. We require that information be obtained on a subset of the doses which we describe as the {\textquoteleft}minimal set{\textquoteright}. We provide a definition of this set and study its role in semiparametric inference concerning the MTD. Focusing inference on the minimal set, and only indirectly on the MTD, has important consequences. Among these is consistency of estimators for both the minimal set and the MTD, in completely general conditions. Even when the goal is only to estimate the MTD, we do no worse, and often better than other methods and without making any sacrifice in terms of safety for the patient. {\textcopyright} 2018, {\textcopyright} American Statistical Association and Taylor & Francis 2018.",
keywords = "clinical trial, continual reassessment method, dose finding methodology, hierarchical model, Sequential design",
author = "Matthieu Clertant and John O'Quigley",
year = "2018",
doi = "10.1080/10485252.2018.1515430",
language = "English",
volume = "30",
pages = "1016--1031",
journal = "Journal of Nonparametric Statistics",
issn = "1048-5252",
publisher = "Taylor and Francis Ltd.",
number = "4",

}

RIS

TY - JOUR

T1 - The role of minimal sets in dose finding studies

AU - Clertant, Matthieu

AU - O'Quigley, John

PY - 2018

Y1 - 2018

N2 - In view of the impossibility theorem of Azriel et al., the Maximum Tolerated Dose (MTD), as currently defined in Phase I and Phase I/II trials, cannot be consistently estimated without making some very strong parametric assumptions. Experimentation carried out at a single dose will fail to provide a consistent estimator of the MTD. We require that information be obtained on a subset of the doses which we describe as the ‘minimal set’. We provide a definition of this set and study its role in semiparametric inference concerning the MTD. Focusing inference on the minimal set, and only indirectly on the MTD, has important consequences. Among these is consistency of estimators for both the minimal set and the MTD, in completely general conditions. Even when the goal is only to estimate the MTD, we do no worse, and often better than other methods and without making any sacrifice in terms of safety for the patient. © 2018, © American Statistical Association and Taylor & Francis 2018.

AB - In view of the impossibility theorem of Azriel et al., the Maximum Tolerated Dose (MTD), as currently defined in Phase I and Phase I/II trials, cannot be consistently estimated without making some very strong parametric assumptions. Experimentation carried out at a single dose will fail to provide a consistent estimator of the MTD. We require that information be obtained on a subset of the doses which we describe as the ‘minimal set’. We provide a definition of this set and study its role in semiparametric inference concerning the MTD. Focusing inference on the minimal set, and only indirectly on the MTD, has important consequences. Among these is consistency of estimators for both the minimal set and the MTD, in completely general conditions. Even when the goal is only to estimate the MTD, we do no worse, and often better than other methods and without making any sacrifice in terms of safety for the patient. © 2018, © American Statistical Association and Taylor & Francis 2018.

KW - clinical trial

KW - continual reassessment method

KW - dose finding methodology

KW - hierarchical model

KW - Sequential design

U2 - 10.1080/10485252.2018.1515430

DO - 10.1080/10485252.2018.1515430

M3 - Journal article

VL - 30

SP - 1016

EP - 1031

JO - Journal of Nonparametric Statistics

JF - Journal of Nonparametric Statistics

SN - 1048-5252

IS - 4

ER -