Phases Of Clinical Trial Flashcards

1
Q

Phases

A

Phase 0 :few objects and few doses (sometimes unethical)
Phase 1: healthy people 20-30+ drug+ check the working and side effects
phase 2: 100-300, work on the effectiveness of the drug
Phase 3: 1000-3000, the safety and effectiveness of the drug, with different populations, if approved by FDA, proceeds to final stage
Phase 4: checked on diverse population for safety and effectiveness

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2
Q

The aim is to obtain data on whether the drug is effective in diagnosis certain conditions in people or not.

A

Phase 2

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3
Q

Most people take part in a clinical trial analysis, because

A

• Because previous medications or treatments haven’t worked
• if there no cure treatment for their condition
• may find new treatment even if they are not available in the market
• others join in to help researcher in their studies

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4
Q

Phases of clinical trial (briefly)

A

Not this time 🥲
Phase 1:
• Evaluate safety
• Determine safe dosage
• identify side effects
Phase 2: • Test effectiveness
• further evaluate safety
Phase 3: • confirm effectiveness
• Monitor side effects
• compare to other treatments
• collect information
Phase 4: provide additional information after approval including: risk, benefits and use

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