Clinical trials Flashcards Preview

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Flashcards in Clinical trials Deck (8):
1

What is a phase 0 or pre-clinical trial phase?

Testing of a drug on non-human subjects to determine if the drug is active and pharmacokinetics

2

What is a phase 1 trial?

Testing of a drug on healthy volunteers at low but escalating doses. Determines dose

3

What is a phase 2 trial?

Testing of a drug on a population of patients with the disease. Determines safety

4

What is a phase 3 trial?

Testing of a drug compared with placebo or another drug, on patients who have the disease. Determines effectiveness compared with placebo or other therapies

5

What is a phase 4 trial?

Post marketing study, for ongoing surviellance to monitor for unseen toxicites previously

6

How many participants are there usually in a phase 1 trial?

Small numbers, 20-100 healthy volunteers

7

How many participants are usually in a phase 2 trial?

Around 100-300 patients with the disease

8

How many participants are there in a phase 3 trial?

Large numbers of patients, 1000-2000, often multi-centre RCTs