Flashcards in Clinical trials Deck (8):
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
What is a phase 1 trial?
Testing of a drug on healthy volunteers at low but escalating doses. Determines dose
What is a phase 2 trial?
Testing of a drug on a population of patients with the disease. Determines safety
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
What is a phase 4 trial?
Post marketing study, for ongoing surviellance to monitor for unseen toxicites previously
How many participants are there usually in a phase 1 trial?
Small numbers, 20-100 healthy volunteers
How many participants are usually in a phase 2 trial?
Around 100-300 patients with the disease