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8.30am - 12.30pm

about the workshop

This workshop is designed to give attending delegates practical lessons in the key stages of designing and analysing an adaptive clinical trial.  For each of the key stages in the design and analysis process, delegates will be taken through the best process, and will be given examples of logistical and regulatory issues and considerations.

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about the leader

Les Huson
Senior Statistical Consultant in Clinical Trials, Statistical Advisory Service, Imperial College London, and Director, GNB Ltd

 

 

 

Les has 25 years' experience of statistical design and analysis of clinical trials (Phase I, II, III, IV).  He has worked in this capacity with a multinational pharmaceutical company, with a CRO, and as freelance consultant/contractor for pharmaceutical and biotech companies.

Les has been responsible for the statistical work on several successful US and European marketing approvals and has substantial experience of liaison with regulatory authorities.  In addition to running his own statistical consultancy, GNB Ltd, Les has teaching responsibilities at Imperial College London.

 

about the organisation

Imperial College London is consistently rated amongst the world's best universities and is a science-based institution with a reputation for excellence in teaching and research.  The Statistical Advisory Service (SAS) exists to help all the staff and postgraduate students of Imperial College with their research. The service also provides statistical help to public bodies and private companies on a commercial basis.  The remit of SAS is wide - offering help with statistics, methodology, and grant applications.

GNB is a specialist statistical consultancy serving clients in the pharmaceutical and biotechnology sectors, providing services in all aspects of statistical work related to the design and analysis of clinical trials. Founded in 1995, it has a reputation for the high quality of our work and the professionalism of its approach.  GNB's services have been instrumental in helping clients to achieve timely US and European Drug Marketing Approvals, and the results of GNB's collaborative work continue to be published in major international peer-reviewed journals.

Workshop programme

8:30 Registration and coffee

9:00 Welcome and introductions

9:10 Overview of the main types of adaptive clinical trial

9:50 Key statistical issues in adaptive trials

10:30 Coffee break

10:50 Regulatory and logistical considerations

11:30 Practical implementation - review of software and methods

12:10 Discussion and questions

12:30 End of workshop

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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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