RAT Quiz Flashcards
Phase 3 Clinical Trials
Also known as
Randomzied Control Trial (RCT)
Number of Participants
Larger Number of People (1000+)
Goal
Determine how safe and effective drug is compared to no treatment (placebo) or current therapy
Duration
Longer than phase 2 (months to years)
Location
Conducted at centres in many cities (multi-centred)
Cost
Most expensive aprt of drug development (1-50 million $)
3 Stages of Phase 3 Trials
- Enrolemnt
- Treatment Allocation
- Results
Enrolment: Target Population
Group of patients for whom the drugs intended for
Enrolment: Study Population
Subset of target population that meets all required crieteria
Excluded
Patients with diseases or conditions that could influence the results
Inclusion
Comorbidities (common conditions present in addition to primary disease) in are often included in trials
Ex. Most common comorbidity of diabetes is hypertension
Treatment Allocation: Double Blind Design
Neither investigator nor the
study subject is aware of the treatment the study subject is assigned to
Treatment Allocation: Randomization
Patients are assigned to the experimental treatment group (receives new drug to be tested) or control group (placebo or gold stanard drug)
Asigned via randomization
Treatment Allocation: Control
Safty of experimental drug is compared to contorl drug which will be either placebo or gold standard drug
Placebo: does not contain active drug but is identical in every other way
Gold Standard: Drug accepted by medical community
Treatment Allocation
-Double Blind Design
-Randomization
-Treatment/Control
