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08/24/2023
A preplanned multi-stage platform trial for discovering multiple superior treatments with control of FWER and power
There is a growing interest in the implementation of platform trials, wh...
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01/25/2023
Adaptive enrichment trial designs using joint modeling of longitudinal and time-to-event data
Adaptive enrichment allows for pre-defined patient subgroups of interest...
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01/24/2023
Improving Software Engineering in Biostatistics: Challenges and Opportunities
Programming is ubiquitous in applied biostatistics; adopting software en...
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11/28/2022
Point estimation for adaptive trial designs II: practical considerations and guidance
In adaptive clinical trials, the conventional end-of-trial point estimat...
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05/24/2022
Bayesian sample size determination in basket trials borrowing information between subsets
Basket trials are increasingly used for the simultaneous evaluation of a...
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04/21/2022
Backfilling Cohorts in Phase I Dose-Escalation Studies
The use of `backfilling', assigning additional patients to doses deemed ...
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03/30/2022
Dose Finding Studies for Therapies with Late-Onset Safety and Efficacy Outcomes
In Phase I/II dose-finding trials, the objective is to find the Optimal ...
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02/08/2022
Online error control for platform trials
Platform trials evaluate multiple experimental treatments under a single...
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12/12/2021
A multi-arm multi-stage platform design that allows pre-planned addition of arms while still controlling the family-wise error
There is growing interest in platform trials that allow for adding of ne...
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05/18/2021
Point estimation for adaptive trial designs
Recent FDA guidance on adaptive clinical trial designs defines bias as "...
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04/30/2021
Dose Finding Studies for Therapies with Late-Onset Toxicities: A Comparison Study of Designs
An objective of phase I dose-finding trials is to find the maximum toler...
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04/30/2021
A Comparison of Model-Free Phase I Dose Escalation Designs for Dual-Agent Combination Therapies
It is increasingly common for therapies in oncology to be given in combi...
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11/06/2020
A Novel Statistical Test for Treatment Differences in Clinical Trials using a Response Adaptive Forward Looking Gittins Index Rule
The most common objective for response adaptive clinical trials is to se...
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11/02/2020
Bayesian sample size determination using commensurate priors to leverage pre-experimental data
This paper develops Bayesian sample size formulae for experiments compar...
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10/07/2020
A Seamless Phase I/II Platform Design with a Time-To-Event Efficacy Endpoint for Potential COVID-19 Therapies
In the search for effective treatments for COVID-19, initial emphasis ha...
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07/09/2020
Adding experimental treatment arms to Multi-Arm Multi-Stage platform trials in progress
Multi-Arm Multi-Stage (MAMS) platform trials are an efficient tool for t...
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06/23/2020
Adding flexibility to clinical trial designs: an example-based guide to the practical use of adaptive designs
Adaptive designs for clinical trials permit alterations to a study in re...
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06/09/2020
Endpoints for randomized controlled clinical trials for COVID-19 treatments
Introduction: Endpoint choice for randomized controlled trials of treatm...
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11/17/2019
A Permutation Test for Assessing the Presence of Individual Differences in Treatment Effects
One size fits all approaches to medicine have become a thing of the past...
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11/13/2019
A Bayesian hierarchical model for bridging across patient subgroups in phase I clinical trials with animal data
Incorporating preclinical animal data, which can be regarded as a specia...
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06/26/2019
Estimation of treatment effects following a sequential trial of multiple treatments
When a clinical trial is subject to a series of interim analyses as a re...
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07/16/2018
Improving Safety of the Continual Reassessment Method via a Modified Allocation Rule
This paper proposes a novel criterion for the allocation of patients in ...
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03/12/2018
An information-theoretic Phase I/II design for molecularly targeted agents that does not require an assumption of monotonicity
For many years Phase I and Phase II clinical trials were conducted separ...
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12/23/2017