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The use of simulation is growing in the design of clinical trial designs as an augmentation of, or replacement for, sample size calculations. Usually this is in order to be able to: estimate operating characteristics of the planned trial other than simply power, to be able to estimate actual type-1 error and power taking into account factors such as the effect of dropouts, and to be able to use trial designs that are too complex for sample size calculation such as adaptive designs

 

This course will introduce statisticians to the software and engineering skills required to write and use a trial simulator. It is intended for statisticians with some experience of programming in R, and introduce them to the design considerations of writing a simulator in R and the testing skills necessary to show that the simulator is correct. It will also introduce statisticians with some experience of trial design to how to think like and engineer and use simulations to test and guide design decisions - how important it is to be able to present single simulations and how to present operating characteristics from many simulations

 

Clinical trial managers & associates
Biostatisticians
Directors of business developement
Data managers
Senior statisticians
Professors of statistics
Directors of Clinical trials
Medical doctors
PhD students
Clinical scientists

 

Accovion; Actelion Pharmaceuticals Ltd; Affibody; AstraZeneca; Bayer HealthCare; Bays Consulting; Berry Consultants, LLP; Bio Med Central; Boehringer-Ingelheim; Cancer Research UK; Cmed CRS Ltd; Cornell University; Daiichi Sankyo; DEBIOPHARM INTERNATIONAL SA; EMD Serono, Inc; Enterome; European Medicines Agency; European Medicines Agency (EMA); GW Pharmaceuticals; H. Lundbeck A/S; Highbury Regulatory Science; hVIVO Services Ltd; ICON Clinical Research; INSERM; Johnson & Johnson; king abdullah international medical research center ; MHRA; Orion Pharma; Pfizer Global Pharmaceuticals; Queen Mary, University of London; Rottapharm Biotech S.r.l.; Sandoz Biopharmaceuticals; Sanofi Aventis; Sanofi Pharma; Sigmaclinical; Synthon BV; The Cure Parkinsons Trust; UCL Cancer Institute; University Of Bath; University of Calgary; University of Pisa; Voisin Consulting Life Sciences; Warwick Medical School ;
 

Workshop LEADER

keynote-img

Tom Parke

Director of Software Solutions, Berry Consultants, LLP

Tom Parke is Director of Software Solutions for Berry Consultants. Tom’s passion and experience has been software for adaptive clinical trials. Prior to joining Berry Consultants, he was Head of Clinical Trial Solutions for Tessella Ltd. While at Tessella for nearly 20 years, he managed the development and running of the software system to support Pfizer’s ASTIN Stroke trial, and has setup multiple software systems to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants. In parallel, he managed projects to develop clinical trial simulators, first with Pfizer, then Wyeth, before acting as the expert advisor and reviewer to the joint development of FACTS with Berry Consultants. Prior to working at Tessella, he worked for Inmos, Imperial Software Technology, and Praxis on compilers, operating systems and real time control systems. He graduated with a Joint First Class Honours in Math and Computer Science from Bristol University in 1979

Berry Consultants, LLP

Berry Consultants is a statistical consulting company specializing in the Bayesian approach to medical statistics, an approach that is radically changing the way research is done throughout the medical industry in both device and drug development. Berry Consultants employs world renowned experts in Bayesian statistics and strives to set the standard for innovative clinical trial design and analysis in the statistical and medical communities
 

Workshop programme

13:30 Registration & Coffee

14:00 Opening remarks and introductions

Tom Parke

Tom Parke, Director of Software Solutions, Berry Consultants, LLP

14:10 Session 1: Introduction

Tom Parke

Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • What is clinical trial simulation
  • Why we need to (and should want to) simulate our trial designs
  • 14:50 Session 2: Case Study

    Tom Parke

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • The background
  • The trial design
  • The structure of the simulator
  • 15:30 Coffee

    16:00 Session 3: Writing a Simulator for the case study

    Tom Parke

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • Lookup tables
  • Output files
  • Parallel processing
  • 16:40 Session 4: So we’ve got a simulator. Now what?

    Tom Parke

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • How to look at the results
  • What to present and how to present it
  • Testing
  • 17:20 Closing remarks

    17:30 End of workshop

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    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    HOTEL BOOKING FORM

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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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