Clinical Research and GCP Update

Developments in trial design

• Pragmatic trials − e.g. testing efficacy in a broad routine clinical practice in everyday settings • Adaptive designs − e.g. multiple, pre-specified, investigational therapies can be compared to identify subgroups who respond best to them • Real world studies − e.g. observational data

• Refining the sample size • Abandoning treatments or doses • Changing the allocation ratio of patients to trial arms • Identifying patients most likely to benefit and focusing recruitment efforts on them • Stopping the whole trial at an early stage for success or lack of efficacy.

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Developments in technology

• Computerized systems • Remote consent • Telemedical monitoring - #stayathome

COVID-19 has been a further catalyst for change

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© Brookwood Global (Canary Ltd) 2021

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