Lernkarten
Quality Mangament of Clinical Trial Center (CTC). What are the important subgroups of organization?
Regulatory Affairs
Monitoring
Data Management & IT-Coordination
Project Management (Trial Unit and Phase-1-unit)
ITT
Trials performed at the CTC. There is no difference between sponsored clinical research and investigator initiated research (ITT). ITT means investigator initiated trials which are performed with industry support (= sponsored trials).
Which trials are performed?
ITT and NCT (non-commercial trials)
epidemiological and observation trials
trials for medical devices
clinical trials in other areas (e.g. surgery)
drugs
PHASE 1 = safety and toxicity.
The important questions adressed are: is dosage safe? How should drug be administered? How is the body affected?
tolerability
metabolism
healthy volunteers
10-50 participants
always symptomatic healthy volunteers
PHASE II = therapeutic explorative. The important questions adressed are: Is the treatment working and how is the body affected?
proof of concept
dose optimizing
side effects
50-200 participants
there is no control group
PHASE III = therapeutic confirmative. The most important question wich is addressed: Risk vs. benefit?
efficacy
statistic significant group: 200-1000 participants
dose optimizing
control group
it is not trying to imitate real conditions
PHASE IV = post marketing authorisation
first: approval by health authorities is required
long-term safety has to be assured
short-term safety has to be assured
focus is on effectivness
subgroup
Which are the types of clinical trials?
Treatment & Prevention
Screening & Diagnostics
Genetics
Quality-of-life / supportive care
Palliative care
Pre-Clinical development is the first stage in drug development. Which is true about it?
takes 3-4 years
one part: selection
one part: pre-clinic
takes 4-5 years
use in galenics, pharmacology and toxicology
