Misc. 2 Flashcards
what document established the need for a legally authorized representative?
declaration of helsinki
who was the declaration addressed to?
physicians
what is significant equity interest?
If the PI gets interest/stock options or any other financial and equity interest during the time of the study and 1 year following completion of the study.
For a publicly traded company, this means more than $50k to PI, spouse or children.
what is a significant payment to an investigator in a covered trial?
monetary value over $25k during the trial or up to 1 year after trial completion
what is a covered trial?
any trial submitted in a marketing application for the FDA proving the effectiveness of the drug or significant contributions to product safety
what is FDA form 482?
Notice of Inspection, from FDA to sponsor letting them know that they are coming to inspect
what is FDA Form 483?
Inspectional Observations form. Result of the FDA audit telling the sponsor what they need to fix
5 key aspects of pre-clinical studies
1) Help establish boundaries for the safe use of treatment when human testing begins
2) Studies designed to evaluate compounds for potential pharmacologic use
3) Generally performed in animals
4) Evaluate the possibility of long-term, adverse events: onset of cancer, interference with reproduction or the induction of birth defects etc.
5) When sufficient data are obtained to warrant study in humans subjects, a sponsor submits an IND
4 key aspects of phase 1 studies
1) Small trials with healthy subjects, purpose is to determine pharmacokinetics and maximum tolerated dose
2) Conducted to determine the appropriate dose range with regard to safety and toxicity (not to evaluate efficacy)
3) Conducted in a limited number (20-80) of health volunteers or patients (cancer, AIDS)
4) Many compounds are abandoned in this phase because of safety/toxicity problems
5 key aspects of phase II studies
1) Initial demonstration of efficacy in patients, short-term safety information
2) Conducted in a relatively limited number (100-300) patients who have the disease
3) Often involve hospitalized patients who can be closely monitored
4) Many focus on dose-response, dosing schedule, or other issues related to preliminary safety and efficacy
5) Takes about 1 to 3 years to complete
5 key aspects of phase III studies
1) Use in large numbers of patients, long-term safety data
2) Conducted in larger (several hundred to several thousand) and more diverse groups for whom the drug is ultimately intended
3) Make comparisons between new treatment and standard therapy or placebo
4) Study a drug used by practicing physicians in the same manner as it would be used after marketing
5) Takes about 2 to 5 years to complete
purpose of phase IV studies
post-marketing, continue assessing therapeutic value and monitor less common AEs
