4.5 Article

Practical implementation of the partial ordering continual reassessment method in a Phase I combination-schedule dose-finding trial

Related references

Note: Only part of the references are listed.
Article Mathematical & Computational Biology

A benchmark for dose-finding studies with unknown ordering

Pavel Mozgunov et al.

Summary: The article introduces a new benchmark evaluation method that takes into account the uncertainty in dose ordering, providing a sharper upper bound on performance. This approach can be applied to trials with multiple endpoints with discrete or continuous distributions.

BIOSTATISTICS (2022)

Article Health Care Sciences & Services

Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic

Sean Ewings et al.

Summary: This study presents a practical approach to design and conduct adaptive dose-finding trials to promote the adoption of these methods. A model-based design for dose-finding trial within the AGILE platform is demonstrated, and the challenges and adaptations encountered in the practical delivery are discussed.

BMC MEDICAL RESEARCH METHODOLOGY (2022)

Article Biology

Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics

Emma Gerard et al.

Summary: Phase I dose-finding trials in oncology aim to determine the maximum tolerated dose of a drug under a specific schedule. The DRtox method proposed in this study uses PK/PD data to estimate the maximum tolerated dose regimen (MTD-regimen) and outperforms traditional designs in correctly selecting the MTD-regimen. This method can provide more precise estimates for the entire dose regimen toxicity curve and recommend alternative untested regimens for expansion cohorts.

BIOMETRICS (2022)

Article Pharmacology & Pharmacy

A dose-finding design for dual-agent trials with patient-specific doses for one agent with application to an opiate detoxification trial

Pavel Mozgunov et al.

Summary: There is a growing interest in early phase dose-finding clinical trials studying combinations of several treatments. The proposed design for a dual-agent combination trial motivated by an opiate detoxification trial results in high accuracy of individual dose recommendation and is robust to model misspecification and assumptions on the distribution of externally defined doses, as shown in a simulation study.

PHARMACEUTICAL STATISTICS (2022)

Article Mathematical & Computational Biology

A straightforward meta-analysis approach for oncology phase I dose-finding studies

Christian Roever et al.

Summary: Phase I clinical studies are crucial for understanding the safety and dose-toxicity relationship of drugs or drug combinations. This study proposes a simple and robust two-stage approach using penalized logistic regression and Bayesian random-effects meta-analysis methodology to estimate the maximum tolerated dose. The methods are investigated through simulations and illustrated with examples from oncology.

STATISTICS IN MEDICINE (2022)

Article Environmental Sciences

Using an Interaction Parameter in Model-Based Phase I Trials for Combination Treatments? A Simulation Study

Pavel Mozgunov et al.

Summary: Studies have shown that including interaction parameters between two compounds in the combination-toxicity model does not improve the accuracy of selection, but results in fewer patients being allocated to the target combination on average.

INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH (2021)

Article Health Care Sciences & Services

Phase I dose-escalation oncology trials with sequential multiple schedules

Burak Kuersad Guenhan et al.

Summary: The study explores sequential phase I trials in oncology, utilizing information from multiple schedules to inform dose decisions. The adapted TITE-PK model demonstrates improved performance in recommending acceptable doses and avoiding toxicity, with similar patient requirements compared to alternatives. It is recommended for phase I oncology trials with sequential multiple schedules.

BMC MEDICAL RESEARCH METHODOLOGY (2021)

Article Oncology

Phase I/II trial of a long peptide vaccine (LPV7) plus toll-like receptor (TLR) agonists with or without incomplete Freund's adjuvant (IFA) for resected high-risk melanoma

Sapna P. Patel et al.

Summary: This study evaluated the safety and immunogenicity of a novel long peptide vaccine with different adjuvants, showing that the LPV7 vaccine induced certain immune responses under various adjuvant strategies, but did not significantly enhance T cell responses compared to vaccines using short peptides.

JOURNAL FOR IMMUNOTHERAPY OF CANCER (2021)

Article Medicine, Research & Experimental

Designing and evaluating dose-escalation studies made easy: The MoDEsT web app

Philip Pallmann et al.

CLINICAL TRIALS (2020)

Article Mathematical & Computational Biology

Improving safety of the continual reassessment method via a modified allocation rule

Pavel Mozgunov et al.

STATISTICS IN MEDICINE (2020)

Article Health Care Sciences & Services

A surface-free design for phase I dual-agent combination trials

Pavel Mozgunov et al.

STATISTICAL METHODS IN MEDICAL RESEARCH (2020)

Article Medicine, Research & Experimental

A comparison of phase I dose-finding designs in clinical trials with monotonicity assumption violation

Rachid Abbas et al.

CLINICAL TRIALS (2020)

Article Mathematical & Computational Biology

A Bayesian time-to-event pharmacokinetic model for phase I dose-escalation trials with multiple schedules

Burak Kuersad Guenhan et al.

STATISTICS IN MEDICINE (2020)

Article Statistics & Probability

An information theoretic approach for selecting arms in clinical trials

Pavel Mozgunov et al.

JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES B-STATISTICAL METHODOLOGY (2020)

Article Statistics & Probability

An information theoretic phase I-II design for molecularly targeted agents that does not require an assumption of monotonicity

Pavel Mozgunov et al.

JOURNAL OF THE ROYAL STATISTICAL SOCIETY SERIES C-APPLIED STATISTICS (2019)

Article Health Care Sciences & Services

How to design a dose-finding study using the continual reassessment method

Graham M. Wheeler et al.

BMC MEDICAL RESEARCH METHODOLOGY (2019)

Article Oncology

The Impact of Early-Phase Trial Design in the Drug Development Process

Mark R. Conaway et al.

CLINICAL CANCER RESEARCH (2019)

Article Health Care Sciences & Services

Implementing the EffTox dose-finding design in the Matchpoint trial

Kristian Brock et al.

BMC MEDICAL RESEARCH METHODOLOGY (2017)

Article Oncology

Embracing model-based designs for dose-finding trials

Sharon B. Love et al.

BRITISH JOURNAL OF CANCER (2017)

Article Mathematical & Computational Biology

On the Use of Co-Data in Clinical Trials

Beat Neuenschwander et al.

STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2016)

Review Multidisciplinary Sciences

The future of immune checkpoint therapy

Padmanee Sharma et al.

SCIENCE (2015)

Article Mathematical & Computational Biology

A comparative study of adaptive dose-finding designs for phase I oncology trials of combination therapies

Akihiro Hirakawa et al.

STATISTICS IN MEDICINE (2015)

Article Mathematical & Computational Biology

Competing designs for drug combination in phase I dose-finding clinical trials

M. -K. Riviere et al.

STATISTICS IN MEDICINE (2015)

Article Pharmacology & Pharmacy

A Bayesian dose-finding design for drug combination clinical trials based on the logistic model

Marie-Karelle Riviere et al.

PHARMACEUTICAL STATISTICS (2014)

Article Mathematical & Computational Biology

Phase I design for completely or partially ordered treatment schedules

Nolan A. Wages et al.

STATISTICS IN MEDICINE (2014)

Article Computer Science, Interdisciplinary Applications

bcrm: Bayesian Continual Reassessment Method Designs for Phase I Dose-Finding Trials

Michael Sweeting et al.

JOURNAL OF STATISTICAL SOFTWARE (2013)

Article Pharmacology & Pharmacy

Specifications of a continual reassessment method design for phase I trials of combined drugs

Nolan A. Wages et al.

PHARMACEUTICAL STATISTICS (2013)

Article Biology

Continual Reassessment Method for Partial Ordering

Nolan A. Wages et al.

BIOMETRICS (2011)