Pharma Interactions Flashcards
preclinical phase of a clinical trial
*~6.5 years
*laboratory and animal studies
*purpose = assess safety and biological activity
*approx 5000 compounds evaluated
**after, must file an IND (investigational new drug) at FDA to use it on humans
phase I of a clinical trial - definition
*researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects
phase I of a clinical trial - simplified
*years = 1.5
*test population = 20-80 HEALTHY volunteers
*purpose = determine safety & dosage
phase II of a clinical trial - definition
*the drug is given to a larger group of people to see if it is effective and to further evaluate its safety
phase II of a clinical trial - simplified
*years = 2
*test population = 100-300 PATIENT volunteers
*purpose = evaluate effectiveness, look for side effects
*success rate = 5 enter clinical trials
phase III of a clinical trial - definition
*the drug or tx is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely
phase III of a clinical trial - simplified
*years = 3.5
*test population = 1000-3000 PATIENT volunteers
*purpose = confirms effectiveness, monitor adverse reactions from long-term use
when does a clinical trial get approved by the FDA
*after phase III
FDA approval of a clinical trial
*years = 1.5
*purpose = review process/approval
phase IV of a clinical trial - definition
*studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use
what does the FDA approve?
*indications - what the drug is approved to be used for
*adverse effects that have been mentioned
*any special monitoring programs
*wording for the “packet insert”
what is meant by being “on label” as a drug manufacturer
keeping the discussion of the medication to what the FDA approved it for
2 types of education that pharma funds/sponsors
1) CME
2) non-CME
CME education
*money paid to program provider (not speaker)
*should have no bias (this is evaluated by learners)
*speaker can say whatever is scientifically valid
*standardized requirements
non-CME education
*money paid to speaker
*need to speak “on label”
*slides usually provided by company after review by their legal team; content should be monitored
*the food is usually better than the information
