encouraging adaptive designs in nihr funded clinical trials
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Encouraging adaptive designs in NiHR funded clinical trials. Professor Sallie Lamb Chair, CET Board. Welcome and Housekeeping. Bathroom facilities Break-out areas Coffee and lunch Fire alarm and drill Travel expenses Queries. Adaptive designs.

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welcome and housekeeping
Welcome and Housekeeping
  • Bathroom facilities
  • Break-out areas
  • Coffee and lunch
  • Fire alarm and drill
  • Travel expenses
  • Queries
adaptive designs
Adaptive designs
  • Most discussion has arisen from drug development and approval trials
  • Most guidance is provided within this context
  • Most methodological development has also been within this context
  • Fit for purpose for NiHR trials (HTA) ?
  • When indicated ?
  • How facilitated ?
adaptive designs1
Adaptive designs
  • Covers many different types of adaptation
  • Futility and early stopping
  • Treatment selection
  • Dose response
  • Sub-group refinement
  • Interim sample size re-estimation
adaptive designs2
Adaptive designs
  • Some applications not well understood
  • Many myths – around speed, cost and method
  • Widely accepted that operational issues are as important as statistical issues
nihr funded research is different
NiHR funded research is different
  • NiHR HTA programme – largest funder of academic clinical trials in the UK – pragmatic, phase III
  • Commissioned and responsive mode
  • NiHR EME programme – phase II/mechanistic
  • NiHR programme grants
  • NiHR fellowship applications
so what is today about
So what is today about
  • Identify the issues
  • Methodological
  • Logistical – recruitment, ethics
  • Logistical - funding arrangements*
  • Talks – stats, trialist, and economics
  • Discussion – stick-its, group work
  • Workshops
  • Dissemination
workshops
Workshops
  • What are the (applied) methodological questions that need to be addressed?
  • What are the practical/organisational implications of using adaptive designs?
  • What guide can we give for when adaptive designs should be considered?
  • How should we encourage the greater use of adaptive designs in NiHR research?
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