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THE FDA – A NEW GUIDANCE ON ADAPTIVE DESIGNS

April 3rd, 2019

The new FDA draft guidance on Adaptive Trials is a significant change from the 2010 version of the draft guidance. This workshop will look at the changes and what it means for submitting proposals for adaptive trials to the FDA.
The workshop will cover:

  • How to submit adaptive designs to regulators
  • What the contents of the documents should be
  • What simulation details need to be submitted
  • What problems to expect
  • How to submit simulation results
  • How to submit simulation software

View workshop programme on the Download Centre

Workshop Leader:
Tom Parke, Director of Software Solutions, Berry Consulting
 

 About the workshop leader


Tom Parke is Director of Software Solutions for Berry Consultants. Tom joined Berry Consultants in 2016 having previously worked at Tessella, a UK scientific software company where he first met and worked with Don Berry. In 1998 Tom managed the development and running of a software system to support Pfizer’s ASTIN Stroke trial – a ground breaking response adaptive randomization dose ranging trial designed by Don Berry and Peter Mueller.


Following that he managed multiple projects to support different aspects of many adaptive clinical trials, mostly designed by Berry Consultants, and projects to develop clinical trial simulators, first with Pfizer, then Wyeth, and finally with Eli Lilly to develop FACTS. Latterly, as well as managing the continuing development of FACTS, Tom has researched the estimation of expected Net Present Value of development programs leading to the development of the QUOTES software package.


Tom originally graduated with joint First Class Honors in Maths and Computer Science from Bristol University, and enjoyed two decades in the software industry (inmos, Imperial Software Technology and then Praxis - which became part of Deloittes) before stumbling upon the wonderful world of adaptive clinical trials.
 

Attend this workshop if you would like to understand:

  • How the new guidance reflects changes at the FDA
  • How to justify the use of an adaptive design to the FDA
  • How to document an adaptive design
  • How to organise, perform, and report the clinical trial simulations necessary to support an adaptive design
  • How to report the results of an adaptive design

 Who should attend:

  • Biostatisticians
  • Clinical project managers
  • Clinical research advisors
  • Clinical Trials Directors
  • Clinical scientists
  • Statisticians
  • Quantitative scientists

Almac Clinical Technologies LLC; Amgen; AstraZeneca; BeiGene; Berry Consultants, LLP; Boehringer-Ingelheim; Chiesi Farmaceutici; DEBIOPHARM INTERNATIONAL SA; Dr. Willmar Schwabe GmbH & Co. KG; Eli Lilly International Corporation; European Medicines Agency (EMA); Ferring Pharmaceuticals A/S; Fraunhofer Institute for Algorithms and Scientific Computing; GCE Solutions; Glenmark Pharmaceuticals; GSK; Highbury Regulatory Science; Janssen; Lundbeck Pharma; Medtronic; Menarini Ricerche SpA; Merck & Company; Mevia; MHRA; MRC Biostatistics Unit; National Institute of Allergy and Infectious Diseases ; Orion Corporation Orion Pharma; Oslo University Hospital; Roche Products Ltd; Sanofi Aventis; SDS; TFS Trial Form Support; TFS, S.L. (CIF: B-60569175); Transgene SA; UCB Pharma Limited; University Of Bath; University of Reading; Lancaster University

Workshop programme

8:30 Registration & Coffee

9:00 Opening Remarks and Introductions

Tom Parke

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

9:10 A look at the draft guidance in detail

Tom Parke

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

  • Changes to the detailed principles
  • Classes of adaptive designs
  • Operational details and considerations
  • Regulatory interaction and submission guidance
  • 9:50 Describing and justifying a proposal to perform an adaptive trial

    Tom Parke

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

  • Statistical efficiency
  • Ethical considerations
  • Operational considerations
  • Broader questions the trial might address
  • Stakeholder flexibility
  •  

    10:30 Morning Coffee

    11:00 Trial simulation necessary to support a complex trial design

    Tom Parke

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

  • How to simulate trials
  • The art of simulating clinical trials – choosing scenarios & choosing operating characteristics
  • Avoiding doing too much
  • Showing type-1 error control
  • 11:40 Submitting the results of an adaptive trial

    Tom Parke

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

  • Analysis of results and analysis code
  • Interim analyses and results
  • Interim communications
     
  • 12:20 Closing remarks

    Tom Parke

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

    12:30 End of workshop

    +

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    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

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    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

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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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