Speakers from this year's event includes:
• Graeme Archer, Director, Quantitative Sciences – Clinical Statistics, GlaxoSAE Media GroupthKline
• Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca
Sandrine Micallef, Clinical Biostatistics Oncology, Sanofi-Aventis
• Giacomo Mordenti, Senior Expert Biostatistician, Merck Serono
• Barbara Bogacka, Reader in Statistics, Queen Mary, University of London
• Markus Niggli, Project Statistician & Annette Sauter, Project Statistician, Roche
• Prof Christopher Jennison, Professor of Statistics, University of Bath
• Frank Fleischer, Teamleader Clinical Biostatistics, Boehringer Ingelheim
• Pantelis Vlachos, Principal Specialist, Merck
• Edwin Wagena, Vice President, Clinical Development, Kiadis Pharma
• Les Huson, Honorary Lecturer in Medical Statistics, Imperial College London
• Yongming Qu, Research Advisor, Eli Lilly
• Yu Shyr, Professor, Cancer Biost
Conference programme
8:30 Registration & Coffee9:00 Chairman's Opening RemarksRobert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca 9:10 Adaptive designs so far: how far have we come?Frank Fleischer, Teamleader Clinical Biostatistics, Boehringer-Ingelheim
The future outlook of adaptive clinical trials
Current trends and recent developments in use of adaptive designs
Moving forward: strategies for successful adaptive clinical trials
9:50 Combining information for adaptive dose selection in early phase trials
Two applications in multiple ascending dose studies using Bayesian models
Optimally integrating safety and efficacy data across studies from healthy volunteers and patients
How to reduce sample size/proportion of overdosed, while making informed decision for subsequent studies
Markus Niggli, Project Statistician, Roche Annette Sauter, Project Statistician, Roche 10:30 Morning Coffee10:50 Implementing adaptive designs: current technology to protect trial integrity Reduce operational bias and build regulatory confidenceEric Silva, Manager of Enterprise and Hosted Solutions , Cytel 11:30 Efficient adaptive design for early clinical trialsBarbara Bogacka, Reader in Statistics, Queen Mary, University of London
Criteria of efficiency
Incorporating PK/PD data into the adaptive decisions
Maximising information from the trial ethically
12:10 Consulting and collaboration: Factors for successfully designing an adaptive trialJurgen Hummel, Associate Statistical Science Director, PPD
Many stakeholders (internal or external) only consider fixed study designs
Case study is used to illustrate how to overcome perceptions about adaptive designs and win over stakeholders, covering:
Consulting services for a small early stage biotechnology company to make development plan more efficient by including several adaptive design elements
Collaboration with Berry Consultants provided relevant simulations and expertise for successful Pre-IND meeting with FDA
12:50 Networking Lunch13:50 Dose finding in oncology: a Bayesian model based approachPantelis Vlachos, Principal Specialist, Merck Serono
Utilise historical data and expert opinion to obtain a ‘best guess’ for the dose-toxicity curve
Update model through MCMC
Simulate course of progress through different scenario and compare with ‘standard designs’
14:30 Phase II adaptive design: worked example using prior data and optimal design theoryPatrick Johnson, Head Global Biometrics, Vifor Pharma
Understanding the main aims of Phase II including characterising dose-response and appropriate dose-selection
Adaptive designs based on dose re-selection after collecting some initial data appear attractive: analysing the potential benefits
Revealing more about an adaptive design that addresses the following issues:
- Initial dose-selection
- Parametric model fitting to interim data supported with prior data from a drug with the same MOA
- Final stage doses and sample size selected using optimal design theory
15:10 Adaptive dose finding incorporating patient choicesLes Huson, Honorary Lecturer in Medical Statistics , Imperial College London
Patients vary in their tolerance of adverse events
Patients and physicians may wish to choose doses based on individual tolerance
Adaptive dose finding methods could incorporate this choice
15:50 Afternoon Tea16:10 An over-arching approach to designing Phase II and Phase III trialsChristopher Jennison, Professor of Statistics, University of Bath
Assessing the probability of success after Phase II results
Optimising dose and sample size for a Phase III trial
A Bayes theory decision framework for jointly planning Phase II and Phase III trials
16:50 Panel discussion: To adapt or not to adapt? Adaptive designs versus conventional trialsThough adaptive designs have been around for decades, only in relatively recent times, since the FDA‘s "Critical Path Opportunities Report" of 2006, has there been a concerted effort by the pharmaceuticals industry to adopt these ideas. As companies embrace these techniques, a critical question is whether to pursue a strategy that may reduce trial times significantly, but with the risk of more complex logistics and regulatory review, or to use a more conventional strategy with traditional clinical trials. This panel discussion will focus on the pros and cons of these two approaches. Christopher Jennison, Professor of Statistics, University of Bath Robert Clay, Vice President Regulatory Affairs, Oncology and Infection, AstraZeneca Les Huson, Honorary Lecturer in Medical Statistics , Imperial College London 17:30 Chairman’s Closing Remarks and Close of Day One8:30 Registration & Coffee9:00 Chairman's Opening RemarksGraeme Archer, Director, Quantitative Sciences - Clinical Statistics, GlaxoSmithKline 9:10 Bayesian approach for Futility Adaptive Design with Time to Event EndpointsGiacomo Mordenti, Senior Expert Biostatician , Merck Serono
Understanding Bayesian adaptive designs
Assessing when a Bayesian adaptive design is useful
Identifying effective interim analysis futility stopping rules
9:50 The challenges of the high-density biomarker adaptive trialsYu Shyr, Professor, Cancer Biostatistics, Vanderbilt University
Understanding high-density biomarker data
Designing high-density biomarker trials including the sample size estimation
Implementing high-density biomarker trial
10:30 Morning Coffee11:00 Escalation with overdose control for bivariate outcomes (safety and activity) in early oncology clinical trialsSandrine Micallef, Senior Biostatistician, Sanofi-Aventis R&D
Bayesian model-based adaptive design taking into account both safety and activity criteria for dose escalation and dose finding
Model involves a monotonous dose-toxicity curve and a flexible (potentially non monotonous) dose-activity curve
Dose escalation and dose-finding rules based on a clinically relevant level of efficacy and a controlled overdose risk
The proposed design can address the dose-finding issues for both cytotoxic compounds and Molecularly Targeted Agents
11:40 Adaptive clinical trials for rare disease medicine development Graeme Archer, Director, Quantitative Sciences - Clinical Statistics, GlaxoSmithKline
Rare Disease clinical development is challenging, due to the rareness of the condition.
Often active comparators don’t exist, while randomisation to placebo can pose ethical difficulties.
Statistical thinking – in terms of inference, as well as (mostly) adaptive trial design – is more important in smaller studies than is the case in traditional, “huge” Phase 3 programmes.
The talk will give some examples of the approaches being developed at GSK Rare Diseases
12:20 Adaptive Designs: Why are they not used more ?Anthony Fox, President, EBD Consulting
Fallacy 1: Adaptive designs are new and therefore not well-understood
Fallacy 2: Choosing whether to propose an adaptive design for a particular clinical trial (and if so, then which) has no simple method to it
Fallacy 3: Adaptive designs are OK for the academics, but have little regulatory / development practicality when it's for-profit product development
12:50 Networking Lunch13:50 Panel Discussion: Potential roadblocks to effective implementation of adaptive trialsAndy Grieve, Senior Vice President Clinical Trial Methodology, Aptiv Solutions
What are the practical barriers to adaptive trial implementation in Pharma Companies
How will these change in the future
14:30 Technologies and processes for the implementation of adaptive clinical trialsAndy Grieve, Senior Vice President Clinical Trial Methodology, Aptiv Solutions
Understand the requirements for successful implementation of adaptive trials
Learn about the technologies that are essential to achieve effective implementation
15:10 Adaptive sequential designs for subgroup selectionBaldur Magnusson, Statistician, Novartis AG
Statistical and practical considerations for subgroup analysis in confirmatory studies
Comparison between different design approaches; fixed vs. flexible adaptation
15:50 Afternoon Tea16:10 On the choice of doses in phase III clinical trials
Modeling probability of success in the later phases of clinical trials
Optimizing the number of doses after a benefit/risk criterion
Vera Lisovskaja, Department of Mathematical Sciences , Chalmers University Of Technology 16:50 Chairman’s Closing Remarks and Close of Day Two
Workshops
Workshop The Grange Holborn Hotel 28th March 2012 London, United Kingdom
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