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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Encouraging adaptive designs in NiHR funded clinical trials

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Encouraging adaptive designs in nihr funded clinical trials

Encouraging adaptive designs in NiHR funded clinical trials

Professor Sallie Lamb

Chair, CET Board


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


Trial phases

Trial phases


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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