10. Clinical Trials Flashcards
Where are Clinical Trials are Conducted
1) Universities and Hospital Research Institutes (30% of the time)
2) Private clinical research organizations (CROs; 70% of the time)
Adverse Events (AEs)
any undesirable experience associated with the use of a medical product in a patient
Exception to phase 1 requirements of healthy volunteers
oncology (cancer drugs) due to ethics issues
because Healthy volunteers are at risk
Telephone Interview Goal
to see whether you are eligible to participate in the trial according to the…
- Trial entry criteria (eligibility criteria & inclusion criteria)
4 Factors of Pharmacokinetics
- Absorption (gut wall- bloodstream)
- Distribution (liver enzymes)
- Metabolism
- Elimination
Pharmacokinetic Testing in Phase 1
Frequent blood & urine tests to measure the concentration of the drug in the body
Average Clinical trial Treatment period
(usually 12-48 weeks)
Average Clinical trial Follow-up visits
Regular visits at the clinic for 2-12 times a year
When is the end of clinical trials
when ALL participants have completed the drug treatment
Sensitivity
The fraction of persons with disease characterized as sick by the test.
Septicity
The fraction of persons without disease characterized as healthy by the test.
Medical Signs
“objective indications of medical state observed from outside the patient”
ie: biomarkers
Medical Symptoms
“Indications of health or illness perceived by patients themselves”
Subjective
Lurasidone
- Acts on Dopamine D2 receptor & Serotonin receptor
- Clinical effects thought to be due to antagonist actions at both receptors
- Has been approved for schizophrenia (onset: late teens & early 20s) and bipolar depression (onset: 15-25 & can be used with lithium or valproate)
