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In association with Tessella
www.tessella.com

About the workshop

Workshop delegates will learn about the practical lessons learnt in the key stages of designing an adaptive clinical trial.  For each of the key stages in the design process (evaluation, comparison and optimisation), delegates will be given hands on experience in the design of a trial.  The workshop will concentrate on phase II designs and compare design issues such as:

  • Response modelling of the endpoint - is a model worthwhile, what models can be considered?
  • What adaptations you should consider during the trial: adaptive allocation, arm dropping, early stopping, none?
  • Longitudinal modelling
  • How to compare fixed and adaptive designs
  • How to optimise the design

About the host

 Tom Parke photo

Tom Parke, Head, Clinical Trial Solutions, Tessella

Tom has been working at Tessella for over ten years, during which he has been working on adaptive clinical trial projects, particularly with Dr Mike Krams and Don and Scott Berry.  Tom has now helped implement a number of adaptive phase II dose-finding trials for a range of pharmaceutical companies across a range of indications.  For these trials, he has managed the development of simulation tools, systems to support the running of the trials and the integration of adaptive algotrithms with existing IVRS and EDC systems.

He is currently leading projects within Tessella to industrialise their support for adaptive trials and is consulting with a number of companies to help them define the software systems they require to move adaptive clinical trials into their mainstream activities.

Before working at Tessella, Tom worked at Praxis (part of Deloitte & Touche), most notably managing projects for part of the air trafiic control system at Heathrow Airport, and control software for imaging systems for GE Medical Systems and Varian Oncology.  Tom originally learned his software trade at inmos (now part of SGS Thomson), and Imperial Software Technology, developing compilers, operating systems and real-time kernels and using formal methods

 Tessella logo

 About the organisation

For over 25 years, Tessella has worked with some of the biggest names in the pharmaceuitcal industry.  We help clients address a wide range of business goals, including improving efficiency and productivity in drug discovery, delivering the business benefits of translational medicine, and faster more effective clinical trials.  What makes our technoloy and consulting services effective is our understanding of both the sci=ence and informatics of pharmaceutical R&D, as well as unique software assts and intellectualy property that reduce project risk, cost and time.  With offices in Europe and North America, global companies rely on Tessella for business critical assignments.

 

Workshop programme

8:30 Registration and coffee

9:00 Welcome and introductions

9:10 Overview

9:50 Evaluating

10:30 Morning tea

10:50 Comparing and optimising adaptive clinical trials

11:30 Discussion session

12:00 Close of workshop

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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?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

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

CPD AND PROFESSIONAL INSTITUTES

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.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

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.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SMI 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.

GLOBAL CPD

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.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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