Clinical Trials Flashcards
Clinical trial oversight is provided by __________.
Institutional review board
Make sure people are protected and federal laws follows
What phase has the most potential risk?
1
What is phase 1 looking for?
What the drug does to the body and what the body does with the drug
How long are pre-clinical studies?
~4 yrs
What does the investigational new drug (IND) application include?
Results from studies
How drug made, who makes it, what’s in it, how stable is it
Detailed outlines for study protocols
Details about clinical trial team
Submitted to FDA
How big of a group is in phase II?
25-100 with the same type of cancer
Usually same dose throughout
No placebo
What is the purpose of phase III?
Comparing safety and effectiveness to current standard treatment
Double blind studies start
What needs to be submitted to the FDA if the new drug is found more effective or safer than the current treatment?
New drug application (NDA)
Research involving people is based on the Belmont Report:
Respect
Beneficence
Justice
What do Data Safety Monitoring Boards do?
Used for phase III
Independent committee of clinical experts, statisticians
Watch progress and results
Can stop trial if clear that the new treatment is much more (or less) effective to allow all people in trial to get the better treatment
What is the clinical investigator in charge of?
Participant recruitment
Protocol writing and submission
Main responsibility is patient safety
What act ensure that health insurance covers the routine cost of care for people approved to be in clinical trials?
Affordable care act
What is a compassionate use program?
Late-phase trials where people who urgently need the treatment can get them
Who safeguards participants in federally funded research?
Office of human research protections (OHRP)
