Zobrazeno 1 - 10
of 642
pro vyhledávání: '"BRETZ, FRANK"'
Dose selection is critical in pharmaceutical drug development, as it directly impacts therapeutic efficacy and patient safety of a drug. The Generalized Multiple Comparison Procedures and Modeling (MCP-Mod) approach is commonly used in Phase II trial
Externí odkaz:
http://arxiv.org/abs/2410.11716
This paper addresses the problem of deciding whether the dose response relationships between subgroups and the full population in a multi-regional trial are similar to each other. Similarity is measured in terms of the maximal deviation between the d
Externí odkaz:
http://arxiv.org/abs/2404.17682
A common problem in clinical trials is to test whether the effect of an explanatory variable on a response of interest is similar between two groups, e.g. patient or treatment groups. In this regard, similarity is defined as equivalence up to a pre-s
Externí odkaz:
http://arxiv.org/abs/2401.05817
Autor:
Fleming, Thomas R, Hampson, Lisa V, Bharani-Dharan, Bharani, Bretz, Frank, Chakravartty, Arunava, Coroller, Thibaud, Koukouli, Evanthia, Wittes, Janet, Yateman, Nigel, Zuber, Emmanuel
Indolent cancers are characterized by long overall survival (OS) times. Therefore, powering a clinical trial to provide definitive assessment of the effects of an experimental intervention on OS in a reasonable timeframe is generally infeasible. Inst
Externí odkaz:
http://arxiv.org/abs/2310.20658
Simultaneous confidence bands (SCBs) for percentiles in linear regression are valuable tools with many applications. In this paper, we propose a novel criterion for comparing SCBs for percentiles, termed the Minimum Area Confidence Set (MACS) criteri
Externí odkaz:
http://arxiv.org/abs/2309.05620
There has been a growing interest in covariate adjustment in the analysis of randomized controlled trials in past years. For instance, the U.S. Food and Drug Administration recently issued guidance that emphasizes the importance of distinguishing bet
Externí odkaz:
http://arxiv.org/abs/2306.05823
Autor:
Dunger-Baldauf, Cornelia, Hemmings, Rob, Bretz, Frank, Jones, Byron, Schiel, Anja, Holmes, Chris
The past few years have seen an increasing number of initiatives aimed at integrating information generated outside of confirmatory randomised clinical trials (RCTs) into drug development. However, data generated non-concurrently and through observat
Externí odkaz:
http://arxiv.org/abs/2210.15264
Regression modeling is the workhorse of statistics and there is a vast literature on estimation of the regression function. It is realized in recent years that in regression analysis the ultimate aim may be the estimation of a level set of the regres
Externí odkaz:
http://arxiv.org/abs/2207.04300
Autor:
Van Lancker, Kelly, Tarima, Sergey, Bartlett, Jonathan, Bauer, Madeline, Bharani-Dharan, Bharani, Bretz, Frank, Flournoy, Nancy, Michiels, Hege, Parra, Camila Olarte, Rosenberger, James L, Cro, Suzie
The COVID-19 pandemic continues to affect the conduct of clinical trials globally. Complications may arise from pandemic-related operational challenges such as site closures, travel limitations and interruptions to the supply chain for the investigat
Externí odkaz:
http://arxiv.org/abs/2202.03531