Clinical Trials Flashcards
What is a CTIMP?
Clinical trial involving investigational medicinal product
“An investigation in human subjects intended to discover or verify the clinical pharmacological and/or other pharmacodynamic effects of an investigational product and/or to identify adverse reactions of an investigational product and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal products”
What is an IMP?
Investigational Medicinal Product
What is a NIMP?
Non-Investigational Medicinal Product
e.g.
♣ Concomitant or rescue/escape medication e.g. folic acid for folate antagonist IMPs
♣ Preventive e.g. Anti-emetics for cytotoxic IMPs or PPIs with a new NSAID
♣ Diagnostic e.g. radiopharmaceutical for imaging
♣ Therapeutic reasons e.g. standard chemotherapy with follow-up maintenance IMP (relapse prevention)
What is PICO?
Patient, population, or problem
Intervention
Comparison
Outcome
What is a dose escalation trial?
Objective is to determine the optimal dose for a drug
Maximum effective dose” The minimum effective dose that cures
Maximum Non toxic dose: (how far you can take the dose of the drug or what range without causing toxic side effects).
Maximum tolerated dose: Tend to be doses used in cancer. How much to give to get most reduction in tumour
What is a parallel study?
One intervention per arm
Participants randomised to each arm
Balanced in each arm
Have a control arm and a treatment arm
What is Best Standard of Care (BSC)?
If there is an active so a drug being used for the disease then you use it as a comparator. If there is no drug in the standard care, then you use the placebo because want to stop bias associated with not using a placebo and having an open labelled study.
What is a single blinded study?
Participants or trial investigator blinded
What is a double blinded study?
Both participants and investigators are blinded
What is a triple blinded study?
People who analyse dont know what treatment the participants are having
What is over-encapsulation?
Bigger capsule around the capsule
What is a factorial design?
More than or equal to 2 interventions in combination and separately against control (at same time)
