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Conference Documentation: Adaptive Designs in Clinical Trials

Day 1
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Graham Clarke, Senior Director, Head of Respiratory & Inflammation Early Clinical Development, Quintiles
9:10
OPENING ADDRESS: Enhancing study design and biomarker read-outs in early clinical development
Graham Clarke, Senior Director, Head of Respiratory & Inflammation Early Clinical Development, Quintiles
9:50
Succeeding in Bayesian Adaptive Design
Sophie Carr, MD and Principal Analyst, Bays Consulting Ltd
10:30
Morning Coffee
11:00
Group Sequential Enrichment Design incorporating subgroup selection – Application to the optimization of the cut-off for a continuous predictive biomarker with time-to-event endpoints
Emilie Gerard, Biostatistician provider, Hays Life Sciences
11:40
Real world patient data in adaptive clinical designs
Mohammad Al-Ubaydli, CEO, Patients Know Best
12:20
Networking Lunch
13:30
Afternoon Chairman's Opening Remarks
Tamas L. Paal, Professor Emeritus and Regulatory Adviser, University of Szeged, Hungary and National Institute of Pharmacy
13:40
KEYNOTE ADDRESS: Outlook of clinical trials in the CEE region
Tamas L. Paal, Professor Emeritus and Regulatory Adviser, University of Szeged, Hungary and National Institute of Pharmacy
14:20
Clinical trials in neurodegenerative disease
Filippo Baldacci, Medical Doctor, Researcher, University of Pisa
15:00
Afternoon Tea
15:30
Bayesian approaches in practice: Examples from early phase Oncology trials
Simon Wandel, Expert Statistical Methodologist, Novartis Pharmaceuticals
16:10
FOCUS4: Designing and delivering an Adaptive-Biomarker driven Multi Arm Mullti Stage (MAMS) cancer trial
Kai-Keen Shiu, FOCUS4 Trial Physician, MRC Clinical Trials Unit, UCL
16:50
Panel Discussion: A rationale on adaptive designs in clinical trials
Tamas L. Paal, Professor Emeritus and Regulatory Adviser, University of Szeged, Hungary and National Institute of Pharmacy
16:50
Panel Discussion: A rationale on adaptive designs in clinical trials
Graham Clarke, Senior Director, Head of Respiratory & Inflammation Early Clinical Development, Quintiles
16:50
Panel Discussion: A rationale on adaptive designs in clinical trials
Loic Darchy, Head of Statistical Methodology Group , Sanofi Aventis
16:50
Panel Discussion: A rationale on adaptive designs in clinical trials
Mohammad Al-Ubaydli, CEO, Patients Know Best
16:50
Panel Discussion: A rationale on adaptive designs in clinical trials
Kai-Keen Shiu, FOCUS4 Trial Physician, MRC Clinical Trials Unit, UCL
17:30
Chairman's Closing Remarks and Close of Day One
Tamas L. Paal, Professor Emeritus and Regulatory Adviser, University of Szeged, Hungary and National Institute of Pharmacy
Day 2
8:30
Registration & Coffee
9:00
Chairman's Opening Remarks
Robert Clay, Consultant, Highbury Regulatory Science; Chief Regulatory Officer, Kinapse; Board Director, TOPRA, Highbury Regulatory Science
9:10
OPENING ADDRESS: Regulatory submissions across the international landscape
Robert Clay, Consultant, Highbury Regulatory Science; Chief Regulatory Officer, Kinapse; Board Director, TOPRA, Highbury Regulatory Science
9:50
Moving from adaptive license to MAPPs (Medicine Adaptive Pathways for Patients (MAPPs)
Elin Haf Davies, Director, Enabling Research
10:30
Morning Coffee
11:00
Adaptive designs in neuroscience drug development
Richard Wyse, Director of Research and Development, The Cure Parkinsons Trust
11:40
Pharmacodynamics biomarkers in early phase oncology trials
Sidath Katugampola, Biomarker Development Scientist, Cancer Research UK
12:20
Networking Lunch
13:30
Novel Response-Adaptive Designs to enhance efficiency of clinical trials with time-to-event outcomes
Alex Sverdlov, Associate Director of Biostatistics , EMD Serono
14:10
Group-sequential response-adaptive designs
Steve Coad, Reader in Statistics, Queen Mary, University of London
14:50
Afternoon Tea
15:20
Bandit models for the design of adaptive clinical trials in rare disease
Sofia Villar, Investigator Statistician , MRC Biostatistics Unit Hub for Trials Methodology Research
16:00
Seamless adaptive designs: Methods for estimating treatment effect
Peter Kimani, Assistant Professor in Medical Statistics, Warwick Medical School
16:40
Chairman’s Closing Remarks and Close of Day Two
Robert Clay, Consultant, Highbury Regulatory Science; Chief Regulatory Officer, Kinapse; Board Director, TOPRA, Highbury Regulatory Science

Conference Documentation: Adaptive Designs in Clinical Trials

Prior to the approval of new drugs, substantial evidence of efficacy is required and safety brought through clinical trials. A massive decline in success rates in Phase II/III of clinical trials has resulted in only 1 in 10 drugs successfully passing through these trials in the US.

With increasing pressure to bring drugs quickly into the market and reduce the cost of drug development, the paradigms of drug dosage studies in phase II trials and the overall adaptive framework of clinical trials are being increasingly challenged. Thus, strategies such as “Seamless Adaptive Designs” and “Group –Sequential Adaptive Designs” are particular areas that have received a great deal of attention in helping to improve the efficiency of drug development.

This conference will review the drug development process and provide a detailed discussion of how adaptive designs are changing the development process. The main focus of the presentation will be to explore the role of adaptive sample sizing; in particular, why it is important to consider the need to reassess sample sizes during the course of a trial. It is designed for those looking to network and gain the latest knowledge from the academics, industry leaders and regulators.


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