Clinical Trials Flashcards by Daniel Blakemore | Brainscape

Q

What are the 2 parts to a phase 1 trial?

A

Single Ascending Dose

Multiple ascending dose

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Q

What is the aim of SAD?

A

find max tolerated dose

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Q

What happens in MAD?

A

ecsalate dose over days and monitor safety

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Q

What are the 2 parts to a phase 2 trial?

A

Phase 2a

Phase 2b

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Q

how many volunteers in a phase 2a trial?

A

20-50 patients

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Q

how many volunteers in a phase 2b trial?

A

50-200 patients

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Q

What design is used in these trials?

A

randomised double blind placebo controlled

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Q

What are phase 3 trials?

A

multi-centre trials

hundreds/thousands of patients

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Q

What happens in phase 3b?

A

label and/or license extensions

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Q

What is the purpose of a phase 4 trial?

A

monitor long term safety

phase 3 trials often miss side effects

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