Clinical Trials Flashcards
Why are clinical trials important?
Provide evidence - practice is evidence based
What is defined as pre-clinical development?
-Investigating animal pharmacology
-Investigating animal toxicology
-Tissue culture
What is phase 1 of clinical development?
Volunteer studies
Clinical pharmacology
100 subjects
Which drugs are not usually seen in phase 1 clinical trials?
Certain cytotoxic drugs - cause harm to individual
What is phase 2 of a clinical trial?
-Up to 500 patients
-Provides some evidence of efficacy and identifies likely dosage range
-Confirms kinetics and dynamics
What is phase 3 of a clinical trial?
-Efficacy is established and evidence of safety is obtained
-Determines if drug works for condition tested
-All data collected and used to request license to sell drug
-1000-10000 patients
What is phase 4 of clinical development of a drug?
-Post marketing surveillance to produce evidence of long term safety
-10,000 - 100,000
What is the purpose of a pilot study?
Test study design
What are the different methods of trials?
-Double blind- patient doctor blinded
-Single blind- patient blinded
-Prospective- protocol decided before hand
-Retrospective- less good, open to bias
What are the stages of a prospective clinical trial?
Design study
Recruit
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?
Patients receive both methods of treatment, one after the other
Cross over stage in middle - “wash out period”, removes all old drug
What is the difference between a superiority VS a Non-inferiority trial?
-Superiority - Shows new treatment is better than control (standard or placebo)
-Non-inferiority - shows new treatment is not worse than standard by much
Shows new treatment would have beaten a placebo arm
Who might you exclude from a clinical trial?
Pregnant women
Children
Seriously ill
Elderly
Patients at risk of side effects
