Adapting pharmacological dose-finding designs for early phase behavioral intervention development research.

2020 ◽  
Author(s):  
Elizabeth Kuhl Towner ◽  
April Idalski Carcone ◽  
Samiran Ghosh ◽  
Steven Ondersma ◽  
Mario Stylianou
Keyword(s):  
Behavioral Intervention ◽  
Early Phase ◽  
Intervention Development ◽  
Dose Finding ◽  
Development Research

A NOVEL BAYESIAN DECISION PROCEDURE FOR EARLY-PHASE DOSE-FINDING STUDIES

1999 ◽  
Vol 9 (4) ◽  
pp. 583-597 ◽  
Author(s):  
Scott Patterson ◽  
Stephen Francis ◽  
Mick Ireson ◽  
Dawn Webber ◽  
John Whitehead
Keyword(s):  
Early Phase ◽  
Decision Procedure ◽  
Dose Finding ◽  
Bayesian Decision

The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension

2022 ◽  
Author(s):  
Christina Yap ◽  
Alun Bedding ◽  
Johann de Bono ◽  
Munyaradzi Dimairo ◽  
Aude Espinasse ◽  
...  
Keyword(s):  
Early Phase ◽  
Reporting Guidelines ◽  
Dose Finding

scholarly journals Unified approach for extrapolation and bridging of adult information in early-phase dose-finding paediatric studies

2016 ◽  
Vol 27 (6) ◽  
pp. 1860-1877 ◽  
Author(s):  
Caroline Petit ◽  
Adeline Samson ◽  
Satoshi Morita ◽  
Moreno Ursino ◽  
Jérémie Guedj ◽  
...  
Keyword(s):  
Early Phase ◽  
Dose Range ◽  
Dose Finding ◽  
Pharmacokinetic Data ◽  
Dose Selection ◽  
Number Of Patients ◽  
Distribution Parameters ◽  
Dose Levels ◽  
Medical Process ◽  
Unified Method

The number of trials conducted and the number of patients per trial are typically small in paediatric clinical studies. This is due to ethical constraints and the complexity of the medical process for treating children. While incorporating prior knowledge from adults may be extremely valuable, this must be done carefully. In this paper, we propose a unified method for designing and analysing dose-finding trials in paediatrics, while bridging information from adults. The dose-range is calculated under three extrapolation options, linear, allometry and maturation adjustment, using adult pharmacokinetic data. To do this, it is assumed that target exposures are the same in both populations. The working model and prior distribution parameters of the dose–toxicity and dose–efficacy relationships are obtained using early-phase adult toxicity and efficacy data at several dose levels. Priors are integrated into the dose-finding process through Bayesian model selection or adaptive priors. This calibrates the model to adjust for misspecification, if the adult and pediatric data are very different. We performed a simulation study which indicates that incorporating prior adult information in this way may improve dose selection in children.

scholarly journals Developing a Psychological–Behavioral Intervention in Cardiac Patients Using the Multiphase Optimization Strategy: Lessons Learned From the Field

2019 ◽  
Vol 54 (3) ◽  
pp. 151-163
Author(s):  
Jeff C Huffman ◽  
Rachel A Millstein ◽  
Christopher M Celano ◽  
Brian C Healy ◽  
Elyse R Park ◽  
...  
Keyword(s):  
Physical Activity ◽  
Decision Making ◽  
Behavioral Intervention ◽  
Development Program ◽  
Intervention Development ◽  
Development Project ◽  
Lessons Learned ◽  
Optimization Strategy ◽  
Coronary Syndrome ◽  
Multiphase Optimization Strategy

Abstract Background The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention. Purpose Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results—and resulting decision-making process—related to experiments at each step to display the practical challenges present at each stage. Methods To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery. Results Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process. Conclusions A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase.

scholarly journals Early-Phase Platform Trials: A New Paradigm for Dose Finding and Treatment Screening in the Era of Precision Oncology

2019 ◽  
pp. 1-8
Author(s):  
Mei-Yin C. Polley ◽  
Ying Kuen Cheung
Keyword(s):  
Early Phase ◽  
Cytotoxic Agents ◽  
Dose Finding ◽  
Stopping Rules ◽  
Precision Oncology ◽  
Cancer Therapies ◽  
New Paradigm ◽  
Cancer Trial ◽  
Targeted Cancer Therapies ◽  
Statistical Designs

Applications in early-phase cancer trials have motivated the development of many statistical designs since the late 1980s, including dose-finding methods, futility screening, treatment selection, and early stopping rules. These methods are often proposed to address the conventional cytotoxic therapeutics for neoplastic diseases and cancer. Recent advances in precision medicine have motivated novel trial designs, most notably the idea of master protocol (eg, platform trial, basket trial, umbrella trial, N-of-1 trial), for the evaluation of molecularly targeted cancer therapies. In this article, we review the concepts and methodology of early-phase cancer trial designs with a focus on dose finding and treatment screening and put these methods in the context of platform trials of molecularly targeted cancer therapies. Because most cancer trial designs have been developed for cytotoxic agents, we will discuss how these time-tested design principles hold relevance for targeted cancer therapies, and we will delineate how a master protocol may serve as an efficient platform for safety and efficacy evaluations of novel targeted therapies.

Practical issues in effective behavioral intervention development.

2010 ◽  
Vol 11 (1) ◽  
pp. 59-76
Author(s):  
Amy Hansford ◽  
Irene Zilber ◽  
Robert H. LaRue ◽  
Mary Jane Weiss
Keyword(s):  
Behavioral Intervention ◽  
Intervention Development
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