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About the workshop

In this workshop, the speaker will describe common opportunities for increasing the efficiency of clinical trial and describe specific statistical approaches that can be used to realize these efficiencies.  The importance of simulation as a tool during the design of a trial and for the communication of the trial design characteristics will be emphasized.  The workshop will include a one-hour interactive session during which the speaker will lead the attendees through the adaptive design process, based either on trials described by the attendees or based on trials familiar to the speaker.  Finally, a brief introduction to a commercially available Bayesian adaptive clinical trial design and simulation software system will be provided.

About the workshop host

Roger J. Lewis, MD, PhD received his PhD in Biophysics in 1986 and his MD in 1987 from Stanford University.  He completed clinical training in emergency medicine in 1990 and is currently a Professor at the David Geffen School of Medicine at UCLA and the Vice Chair for Academic Affairs in the Department of Emergency Medicine at Harbor-UCLA Medical Center.  He is also Senior Medical Scientist at Berry Consultants, LLC, a statistical consulting group specializing in the development and implementation of adaptive Bayesian clinical trials in both industry and academic settings.  Dr. Lewis’s expertise centers on clinical research methodology, including adaptive and Bayesian trial design, and he participates in the design and analysis of numerous laboratory, clinical, and health services research studies.  His areas of interest include adaptive and Bayesian clinical trials; translational, clinical, health services and outcomes research; emergency department crowding and disaster preparedness, interim data analysis; the role and function of data monitoring committees; and difficulties surrounding informed consent in emergency research studies.  Dr. Lewis serves as the chair of data and safety monitoring boards (DSMB) for both federally-funded and industry-sponsored clinical trials.

About the organisation

Berry Consultants, LLC is a statistical consulting group specializing in adaptive clinical trial design in pharmaceutical and medical device research and development.  The statisticians at Berry Consultants are leaders in the Bayesian approach to medical statistics, an approach that is radically changing the way research is done throughout the medical industry (device and drug development).  Berry Consultants employs world renowned experts in Bayesian statistics and strive to set the standard for Bayesian design and analysis in the statistical and medical communities.

 

 

 

Workshop programme

8:30 Registration & Coffee

8:50 Chairman's Opening Remarks

9:10 Opportunities for Efficiency: Building Blocks for a Bayesian Adaptive Clinical Trial

9:10 Welcome, introduction and workshop plan

9:50 Simulation as a Communication and Design Tool

10:15 Examples of Efficiency: Illustrative Clinical Trial Designs

10:45 Morning Coffee

11:00 Interactive Workshop: Group Participation in Conceptual Design of Adaptive Clinical Trials

12:00 The FACTS software tool

12:30 Discussion

12:45 Close of Workshop

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The Grange Holborn Hotel

50-60 Southampton Row
London WC1B 4AR
United Kingdom

The Grange Holborn Hotel

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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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