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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. 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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  1. Encouraging adaptive designs in NiHR funded clinical trials Professor Sallie Lamb Chair, CET Board

  2. Welcome and Housekeeping • Bathroom facilities • Break-out areas • Coffee and lunch • Fire alarm and drill • Travel expenses • Queries

  3. 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 ?

  4. Adaptive designs • Covers many different types of adaptation • Futility and early stopping • Treatment selection • Dose response • Sub-group refinement • Interim sample size re-estimation

  5. 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

  6. 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

  7. Trial phases

  8. 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

  9. 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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