• Home
  • Search
  • Improved inference for MCP-Mod approach using time-to-event endpoints with small sample sizes.
  • Open Access IconOpen Access
  • Cite Icon2
  • https://doi.org/10.1002/pst.2303Copy DOI Icon

Improved inference for MCP-Mod approach using time-to-event endpoints with small sample sizes.

Show More
  • Abstract
  • Literature Map
  • References
  • Citations
  • Similar Papers
Abstract

The Multiple Comparison Procedures with Modeling Techniques (MCP-Mod) framework has been recently approved by the U.S. Food, Administration, and European Medicines Agency as fit-for-purpose for phase II studies. Nonetheless, this approach relies on the asymptotic properties of Maximum Likelihood (ML) estimators, which might not be reasonable for small sample sizes. In this paper, we derived improved ML estimators and correction for their covariance matrices in the censored Weibull regression model based on the corrective and preventive approaches. We performed two simulation studies to evaluate ML and improved ML estimators with their covariance matrices in (i) a regression framework (ii) the Multiple Comparison Procedures with Modeling Techniques framework. We have shown that improved ML estimators are less biased than ML estimators yielding Wald-type statistics that controls type I error without loss of power in both frameworks. Therefore, we recommend the use of improved ML estimators in the MCP-Mod approach to control type I error at nominal value for sample sizes ranging from 5 to 25 subjects per dose.

Similar Papers
  • Research Article
  • Citations1

Comparative Study of Blu and ML Estimators of Location and Scale Parameters of an Extreme Value Distribution for Small Samples and Type I Censorship

  • Jan 01, 1989
  • Communications in Statistics - Simulation and Computation
  • Mohamed M Bugaighis
  • Research Article
  • Citations2

Restricted maximum likelihood estimation under Eisenhart model Ill

  • Sep 01, 1991
  • Statistica Neerlandica
  • K.R Lee +1
  • Research Article
  • Citations94

Federated Edge Learning With Misaligned Over-the-Air Computation

  • Jun 01, 2022
  • IEEE Transactions on Wireless Communications
  • Yulin Shao +2
  • Research Article

Estimation of multivariate probit models: A mixed generalized estimating/pseudo-score equations approach and some finite sample results

  • Jan 01, 1996
  • Open access LMU (Ludwid Maxmilian's Universitat Munchen)
  • Martin Spieß +1
  • Research Article
  • Citations87

Person reidentification by minimum classification error-based KISS metric learning.

  • Jun 03, 2014
  • IEEE Transactions on Cybernetics
  • Dapeng Tao +3
  • Research Article
  • Citations4474

The generalized correlation method for estimation of time delay

  • Aug 01, 1976
  • IEEE Transactions on Acoustics, Speech, and Signal Processing
  • C Knapp +1
  • Research Article
  • Citations5

Cramér–Rao Bound Analysis of Reverberation Level Estimators for Dereverberation and Noise Reduction

  • Aug 01, 2017
  • IEEE/ACM Transactions on Audio, Speech, and Language Processing
  • Ofer Schwartz +2
  • PDF
  • Research Article

Robust Estimation for Proportional Odds Model through Monte Carlo Simulation

  • Jul 01, 2021
  • Mathematics and Statistics
  • Faiz Zulkifli +3
  • Conference Article
  • Citations2

Non asymptotic efficiency of a Maximum Likelihood estimator at finite number of samples

  • Jan 07, 2010
  • INFM-OAR (INFN Catania)
  • Alexandre Renaux +2
  • PDF
  • Research Article
  • Citations2

Timing and Carrier Synchronization by Offset Estimation for Cooperative Relay Networks

  • May 11, 2015
  • Indian Journal of Science and Technology
  • K Sureshkumar +2
  • Research Article
  • Citations18

A comparison of Bayesian to maximum likelihood estimation for latent growth models in the presence of a binary outcome

  • Jan 10, 2020
  • International Journal of Behavioral Development
  • Su-Young Kim +3
  • Conference Article

Estimation of laser system pointing parameters using a near-Gaussian irradiance profile

  • Aug 20, 2009
  • Proceedings of SPIE, the International Society for Optical Engineering/Proceedings of SPIE
  • Sreedhar Aeddy +3
  • Research Article

Restricted EM algorithm with application to probit models

  • Oct 01, 2002
  • Applied Economics Letters
  • Sunil K Sapra
  • Conference Article
  • Citations1

Exploiting HF ambient noise to synchronize distributed receivers

  • Jan 01, 2013
  • David Hong +1
  • Research Article
  • Citations11

On the robustness properties for maximum likelihood estimators of parameters in exponential power and generalized T distributions

  • Dec 31, 2018
  • Communications in Statistics - Theory and Methods
  • Mehmet Niyazi Çankaya +1
Cactus Communications logo

Copyright 2026 Cactus Communications. All rights reserved.