Flashcards in Clinical Trials Deck (15):
Why are clinical trials important?
They provide evidence - practice is evidence based
What is defined as pre-clinical development?
Investigating animal pharmacology
Investigating animal toxicology
What is phase 1 of clinical development?
Clinical pharmacology in normal 'healthy' volunteers generating pharmacokinetic, metabolic and pharmacodynamic data.
Which drugs are not usually seen in phase 1 clinical trials?
Certain cytotoxic drugs - that cause harm to the individual
What is phase 2 of a clinical trial?
Involves up to 500 patients
Provides some evidence of efficacy and identifies a likely dosage range
Confirms kinetics and dynamics
What is phase 3 of a clinical trial?
Efficacy is established and evidence of safety is obtained
It determines if the drug works for the condition we are testing
All data collected and used to request a license to sell the drug
What is phase 4 of clinical development of a drug?
Post marketing surveillance to produce evidence of long term safety
What is the purpose of a pilot study?
To test study design
What are the different methods of trials?
What are the stages of a prospective clinical trial?
Design the study, recruit, then follow up
What is a retrospective clinical trial?
When data is collected from case records after treatment is given
What is a cross over study?
When patients receive both methods of treatment, one after the other with a cross over stage in the middle called a "wash out period" - removes all the old drug
What is the difference between a superiority VS a Non-inferiority trial?
Superiority - Shows that a new treatment is better then control (standard or placebo)
Non-inferiority - shows that the new treatment is not worse than the standard by much
Shows that the new treatment would have beaten a placebo arm
Who might you exclude from a clinical trial?
Patients at risk of side effects