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The FDA – a new guidance on adaptive designs
1 April 2019
The FDA – a new guidance on adaptive designs

THE FDA – A NEW GUIDANCE ON ADAPTIVE DESIGNS

April 1st, 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The new FDA draft guidance on Adaptive Trials is a significant change from the 2010 version of the draft guidance.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.
 

Workshop agenda

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17:30

Opening Remarks and Introductions

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

clock

17:40

A look at the draft guidance in detail

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
  • clock

    18:10

    Describing and justifying a proposal to perform an adaptive trial

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

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

     

  • clock

    18:40

    Morning Coffee

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    19:00

    Trial simulation necessary to support a complex trial design

    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
  • clock

    19:30

    Submitting the results of an adaptive trial

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

  • Analysis of results and analysis code
  • Interim analyses and results
  • Interim communications
     
  • clock

    20:00

    Closing remarks

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

    clock

    20:10

    End of workshop

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