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Planning for Success: Adapt by Design
2 February 2010
Planning for Success: Adapt by Design

In association with Cytel Inc
www.cytel.com

About the workshop

This half-day workshop will cover the latest techniques and software for accurate planning and successful execution of adaptive trials.
 
Join noted adaptive trial expert Yannis Jemiai for an in-depth look at the most effective approaches for planning and efficient implementation of adaptive trials.

In a wide-ranging format, Yannis will review current international regulatory attitudes, while also revealing methods and software specifically for planning and successfully running adaptive trials.

Actual early and confirmatory adaptive trial case studies will help illustrate how to overcome the challenges, and take full advantage of today's era of adaptive development.

Planning: how do you know you have a good design?

  • Asking the right development questions - how to avoid racing towards the wrong answer
  • The role of simulations during the design phase
  • Assessing options and determining the best design
  • Assessing the impact on the clinical development strategy
  • Working with colleagues - preparing internally for success
  • Working with regulators

Implementation: are you fully prepared to implement adaptive changes?

  • The role of simulation during the execution phase
  • Supply forecasting and cost analysis
  • Forecasting site accrual rates
  • Interim analysis - who sees what and when?
  • Protecting trial integrity
  • Implementing the recommended changes
  • New adaptive randomisation schemes
  • Final study data analysis considerations

About the host

 Yannis Jemiai

Yannis Jemiai, Associate Director of Biostatistics, Cytel Inc

Yannis has trained hundreds of statisticians and clinicians with Cytel, also consulting on early, confirmatory and seamless adaptive designs, survival studies, and trial data analysis strategies.

Yannis also oversees the progression of East®, Cytel's widely used adaptive and group-sequential design software.  He is also responsible for the development of the recently introduced SiZ® software for fixed sample trial design simulation and analysis.

Yannis is often invited to speak on innovative adaptive trial techniques and his own research has been published in numerous peer-reviewed statistical journals. Yannis earned his Ph.D. from Harvard University, an M.P.H. from Columbia University, and a B.A. in Molecular and Cellular Biology also from Harvard.
 

Cytel logo

 

Workshop agenda

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13:30

Registration and coffee

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14:00

Welcome and introductions

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14:10

Planning: how do you know you have a good design?

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15:10

Afternoon tea

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15:30

Implementation: are you fully prepared to implement adaptive changes?

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16:30

Discussion session

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17:00

Close of workshop

VENUE

Crowne Plaza Hotel - St James

Buckingham Gate 45/51, London, United Kingdom

A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
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Crowne Plaza Hotel - St James

Buckingham Gate 45/51
London SW1E 6AF
United Kingdom

Crowne Plaza Hotel - St James

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WHAT IS CPD?

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CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

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There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

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TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

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As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

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Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

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