Design of experiments in healthcare

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Workshop theme

The purpose of this workshop is to gather together people working in various aspects of design of experiments in health-care, in the widest understanding of that word, from drug development in pre-clinical and clinical trials, treatment individualization, studies on primary care, and gathering evidence for public policy, to choice experiments in health economics. Participants and speakers include experts from industry and academia. Several talks will specifically focus on challenges and problems arising with the practical implementation of proposed strategies. Presentations describing both the current attempts to use DoE to overcome the recognized inefficiencies of the traditional drug development as well as the new challenges in implementing the DoE in clinical trials will be a basis for exchange of information among the researchers from the pharmaceutical companies, regulatory authorities, and from academia.

Presentations will be organized in sessions around the following themes:

Treatment individualization
Cluster randomized trials
Step wedge designs
Adaptive dose ranging study
Choice experiments in health economics
Designs for drug development
Biomarkers and covariate adaptive designs
Early phase model based design

Timetable

Monday 15th August 2011
08:00 to 08:55	Registration	No Room Required
08:55 to 09:00	Welcome from John Toland (INI Director Designate)	Room 1
09:00 to 09:45	Val Fedorov None / Other Design of clinical trials with multiple end points of different types	Room 1
09:45 to 10:30	Andy Grieve ClinResearch The Role of Operating Characteristic in Assessing Bayesian Designs in Pharmaceutical Drug Development	Room 1
10:30 to 11:00	Morning coffee	No Room Required
11:00 to 11:45	Don Berry M. D. Anderson Cancer Center The Critical Path: "Biomarker Development and Streamlining Clinical Trials"	Room 1
11:45 to 12:30	Anthony Atkinson London School of Economics Experiments for Enzyme Kinetic Models	Room 1
12:30 to 13:30	Lunch at Wolfson Court	No Room Required
14:00 to 14:45	Jack Lee M. D. Anderson Cancer Center; University of Texas M D Anderson Cancer Center Biomarker-based Bayesian Adaptive Designs for Targeted Agent Development - Implementation and Lessons Learned from the BATTLE Trial	Room 2
14:00 to 14:45	Allan Donner University of Western Ontario The Role of Cluster Randomization Trials in Health Research	Room 1
14:45 to 15:25	J. Kyle Wathen M. D. Anderson Cancer Center ISPY-2: Adaptive Design to Identify Treatments for Biomarker	Room 2
14:45 to 15:25	Mike Campbell University of Sheffield Cluster Randomised Trials: coping with selective recruitment, baseline covariates and anticipated drop-outs?	Room 1
15:25 to 16:05	Sandra Eldridge Queen Mary University of London Sample size calculations for cluster randomised trials	Room 1
15:25 to 16:05	Thomas Braun University of Michigan Bayesian Adaptive Designs for Identifying Maximum Tolerated Combinations of Two Agents	Room 2
16:05 to 16:35	Afternoon tea in main building	No Room Required
16:35 to 17:15	Dose Selection Incorporating PK/PD Information in Early Phase Clinical Trials.	Room 2
16:35 to 17:15	Ian White MRC Biostatistics Unit A cluster-randomised cross-over trial	Room 1
17:15 to 17:55	Ken Cheung Columbia University Objective Calibration of the Bayesian Continual Reassessment Method	Room 2
17:15 to 17:55	Charles Weijer University of Western Ontario Ethical issues posed by cluster randomized trials in health research	Room 1
18:15 to 19:00	Dinner at Murray Edwards College (residents only)	No Room Required
19:00 to 19:45	Welcome wine reception and posters	No Room Required

Tuesday 16th August 2011
09:30 to 10:00	Vladimir Dragalin ClinResearch Adaptive Dose-Ranging Designs with Two Efficacy Endpoints	Room 1
10:00 to 10:30	Luc Pronzato CNRS (Centre national de la recherche scientifique); Université de Nice Sophia Antipolis Penalized optimal design for dose finding	Room 1
10:30 to 11:00	Chris Jennison University of Bath Jointly optimal design of Phase II and Phase III clinical trials: an over-arching approach	Room 1
11:00 to 12:30	DAE informal discussion	Room 2
11:00 to 11:30	Morning coffee	No Room Required
11:30 to 12:00	Sue-Jane Wang U. S. Food and Drug Administration (FDA) Utility and pitfals of dose ranging trials with multiple study objectives: fixed or adaptive	Room 1
12:00 to 12:30	José Pinheiro Johnson & Johnson PRD Improving dose-finding methods in clinical development: design, adaptation, and modeling	Room 1
12:30 to 13:30	Lunch at Wolfson Court	No Room Required
14:00 to 14:30	Frank Bretz Novartis Institutes for Biomedical Research Response-adaptive dose-finding under model uncertainty	Room 1
14:30 to 15:00	Helene Thygesen Lancaster University Dose Escalation using a Bayesian Model: rational decision rules.	Room 1
15:00 to 15:30	Beat Neuenschwander Novartis Institutes for Biomedical Research Bayesian approaches to Phase I clinical trials: methodological and practical aspects	Room 1
15:30 to 16:00	Sergei Leonov Vertex Pharmaceuticals Application of model-based designs in drug development	Room 1
16:00 to 16:45	Afternoon tea	No Room Required
16:45 to 18:00	Michael Krams Janssen Pharmaceuticals Design of Experiments in Healthcare, dose-ranging studies, astrophysics and other dangerous things	Room 1
18:15 to 19:00	Dinner at Murray Edwards College (residents only)	No Room Required

Wednesday 17th August 2011
09:00 to 09:45	Jordan Louviere University of Technology Sydney A Brief History of DCEs and Several Important Challenge	Room 1
09:45 to 10:30	Mandy Ryan University of Aberdeen Discrete Choice Experiments in Health Economics	Room 1
10:30 to 11:00	Morning coffee	No Room Required
11:00 to 11:45	Jeremy Taylor University of Michigan Systematic review of the use of stepped wedge cluster randomized trials	Room 2
11:00 to 11:45	John Rose University of Technology Sydney Sample size, statistical power and discrete choice experiments: How much is enough	Room 1
11:45 to 12:30	Peter Goos Universiteit Antwerpen Optimal designs for discrete choice experiments in the presence of many attributes	Room 1
11:45 to 12:30	Larry Moulton Johns Hopkins University Challenges in the Design and Analysis of a Randomized, Phased Implementation (Stepped-Wedge) Study in Brazil	Room 2
12:30 to 13:00	Heiko Grossmann Otto-von-Guericke-Universität Magdeburg Partial profile paired comparison designs for avoiding information overload	Room 1
12:30 to 13:00	Robin Thompson Rothamsted Research Stepped wedge randomised trials	Room 2
13:00 to 14:00	Lunch at Wolfson Court	No Room Required
14:00 to 17:00	Excursion: walk to Grantchester Orchard Tea Garden	No Room Required
19:30 to 22:30	Hog Roast Garden Party at The Moller Centre	No Room Required

Thursday 18th August 2011
09:00 to 09:45	Emily Lancsar Monash University Discrete choice experimental design for alternative specific choice models: an application exploring preferences for drinking water	Room 1
09:45 to 10:30	Roselinde Kessels Universiteit Antwerpen The usefulness of Bayesian optimal designs for discrete choice experiments	Room 1
10:30 to 11:00	Morning coffee	No Room Required
11:45 to 12:30	Peter van de Ven Vrije Universiteit Medical Center An efficient alternative to the complete matched-pairs design for assessing non-inferiority of a new diagnostic test	Room 1
12:30 to 13:30	Lunch at Wolfson Court	No Room Required
14:00 to 14:45	Yuan Ji M. D. Anderson Cancer Center From Bench to Bedside: The Application of Differential Protein Networks on Bayesian Adaptive Designs for Trials with Targetted Therapies	Room 1
14:45 to 15:30	KyungMann Kim University of Wisconsin-Madison A Bayesian Adaptive Design with Biomarkers for Targeted Therapies and Some Commentary on Adaptive Designs	Room 1
15:30 to 16:00	Afternoon tea	No Room Required
16:00 to 16:45	Peter Thall M. D. Anderson Cancer Center; Rice University Optimizing the Concentration and Bolus of a Drug Delivered by Continuous Infusion	Room 1
16:45 to 17:30	Bhramar Mukherjee University of Michigan Discussion of three talks on (covariate) adaptive designs	Room 1
18:15 to 19:00	Dinner at Murray Edwards College (residents only)	No Room Required

Friday 19th August 2011
09:45 to 10:30	Bjoern Bornkamp Novartis Institutes for Biomedical Research Functional uniform prior distributions for nonlinear regression	Room 1
10:30 to 11:00	Morning coffee	No Room Required
11:00 to 11:45	Marina Savelieva Praz Novartis Institutes for Biomedical Research PKPD modelling to optimize dose-escalation trials in Oncology	Room 1
11:45 to 12:30	Jeremy Taylor University of Michigan Designs and models for Phase I oncology trials with intra-patient dose escalation	Room 1
12:30 to 13:30	Lunch at Wolfson Court	No Room Required
14:00 to 14:45	Nancy Flournoy University of Missouri Some Issues Response-Adaptive Designs for Dose-finding Experiments	Room 1
14:45 to 15:30	William Rosenberger George Mason University Principles for Response-Adaptive Randomization	Room 1
15:30 to 16:15	Alessandra Giovagnoli University of Bologna Recent developments in adaptive clinical trials to account for individual and collective ethics	Room 1
16:15 to 16:20	Closing remarks	Room 1
18:15 to 19:00	Dinner at Murray Edwards College (residents only)	No Room Required

Speakers

Anthony Atkinson London School of Economics
Don Berry M. D. Anderson Cancer Center
Bjoern Bornkamp Novartis Institutes for Biomedical Research
Thomas Braun University of Michigan
Frank Bretz Novartis Institutes for Biomedical Research
Mike Campbell University of Sheffield
Ken Cheung Columbia University
Allan Donner University of Western Ontario
Vladimir Dragalin ClinResearch
Sandra Eldridge Queen Mary University of London
Val Fedorov None / Other
Nancy Flournoy University of Missouri
Alessandra Giovagnoli University of Bologna
Peter Goos Universiteit Antwerpen
Andy Grieve ClinResearch
Heiko Grossmann Otto-von-Guericke-Universität Magdeburg
Chris Jennison University of Bath
Yuan Ji M. D. Anderson Cancer Center
Roselinde Kessels Universiteit Antwerpen
KyungMann Kim University of Wisconsin-Madison
Michael Krams Janssen Pharmaceuticals
Emily Lancsar Monash University
Jack Lee M. D. Anderson Cancer Center; University of Texas M D Anderson Cancer Center
Sergei Leonov Vertex Pharmaceuticals
Jordan Louviere University of Technology Sydney
Larry Moulton Johns Hopkins University
Bhramar Mukherjee University of Michigan
Beat Neuenschwander Novartis Institutes for Biomedical Research
José Pinheiro Johnson & Johnson PRD
Luc Pronzato CNRS (Centre national de la recherche scientifique); Université de Nice Sophia Antipolis
John Rose University of Technology Sydney
William Rosenberger George Mason University
Mandy Ryan University of Aberdeen
Marina Savelieva Praz Novartis Institutes for Biomedical Research
Jeremy Taylor University of Michigan
Peter Thall M. D. Anderson Cancer Center; Rice University
Robin Thompson Rothamsted Research
Helene Thygesen Lancaster University
Peter van de Ven Vrije Universiteit Medical Center
Sue-Jane Wang U. S. Food and Drug Administration (FDA)
J. Kyle Wathen M. D. Anderson Cancer Center
Charles Weijer University of Western Ontario
Ian White MRC Biostatistics Unit

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