Week 1 Flashcards
(61 cards)
What is a sponsor in a clinical trial?
it is a company that can benefit financially once the drug/deviceis approved for sale
What is a Prinicple investigator is?
person that conduct a CT at their clinical site
What authority regulates CT
in us FDA; National instate of heallth depending on who is conducting the trial
What is a CRF
a case report form. Principle instrument used to collect data in a. CT
What are the two types of CRF?
Paper -
or EDC - electronic data collection on computer. Basically a database where someone enters in info. `
What is a CT?
Short words: an Experiment
RS study in human subjects that is designed to answer questions about a specific drug/device to use as a possible treatment that can generate safe and efficacy data.
What are they attempting to do or the process in CT (5)
Want to generate data set of a drug that is being studied in population of patients,
take data and analyze to determine if its safe and effective,
submit to reg auth,
approval for market,
sell`
A CT involves a__
PI
what does a PI do___
conducts the trial
Who is the PI Overseen by?
IRB
What are the 3 things the IRB will make sure the PI does?
Make sure they are designing and conducting it according to the study protocol, Regulatory requirements, GCP Guidelines
Who is A PI usually
physician/ doc who works in the academic center where rs is done
Study Protcol?
a document that explains exactly how the trial will be conducted, how they will recruit participants
Regulatory req?
FDA/NIH have certain reg req that we are req to abide by and conduct by
GCP Guidelines? Which one>
One type is the International Conference on Harmoniztion (ICH). Their GCP guidelines are located in section E6.
Who is the data collected by? and on behalf of who?
who is it submitted to?
PI; sponsor; FDA for approval
Even if trial is being conducted under jurisdiction of US FDA what is still true?
There are times where there are site or trials in EUROPE or SA, CHINA but US FDA still has jurisdiction in those location
they reuquiere PI to adhere to certain reg req even if outside of us
What is the drug dvp timeline?
Preclinical testing (03)
Clinical Testing on Human Subjects (4-11)
- Phase 1
-Phase 2
-phase 3
-sometimes phase 4
Drug on sale (12) `
What happens in Preclinical testing?
-do lab testing on animals start with mice and move up to larger animals.
-find toxic level in animals to see how much it will take to kill an animal
What occurs in phase 1? who and how many people are involved?
There is about 10-100 healthy volunteers. Usually college students.
- figuring out what doses are safe for people to use
What occurs in phase 2? who and how many people are involved?
200-1000 volunteers. These people suffer from the medication so heart disease or diabetes.
-start to collect efficacy data: Are these people benefiting from it?
What occurs in phase 3? who and how many people are involved?
3000 + Patients. In difference contries and in multiple centers
Phase 3 introduces what?
Multiple treatment arms so Blinded, placebo.
Also compares drug with one existing drug.
What phase does the data get submitted to the FDA
phase 3
