University:
University of Wolverhampton
Course:
4PY019 | Pharmacy
Academic year:

2024
Views:

307

Pages:

2
Author:

Sara

Which of these is NOT a step in drug discovery? Lead refinement What is a phase 1 clinical trial? A small group of healthy individuals is given a drug. This assesses safety. What is a phase 2 clinical trial? A larger group of patients that have the disease to be treated - looks at efficacy. What is phase 3 of clinical trials? Therapeutic effects and toxicity in a large population and is well-controlled What is a phase 4 clinical trial? post marketing surveillance Which of these is NOT part of clinical trial design? Specific grouping Which of these is NOT part of the PICO model? Carfeulness What is the PICO model? P: Patient, Probability, Population I: Intervention C: Comparison O: Outcome What is a double blind study? both subjects and the experimenter do not know who has been assigned to which group in order to prevent bias What is a single-blind study? subjects do not know what group they're in in order to prevent bias What is selection bias? refers to bias in how people are chosen to participate What is performance bias? Systematic differences between groups in the care that is provided, or in exposure to factors other than the interventions of interest What is detection bias? Biased assessment of outcomes What is attrition bias? Participants in one group more likely to drop out than another group What is reporting bias? selective reporting of data 1/2 maintains randomisation ALL patients included in statistical analyWhat is the intention-to-treat principle? sis represents "real world" increases external validity What is interim analysis? intended to compare treatment arms for efficacy or safety at any time prior to the formal completion of a trial What is sub-group analysis? Breakdown study sample into subsets of participants that share certain characteristics. Look at the differences in how certain people respond to certain interventions What is Cost-Effectiveness Analysis? Is defined as a series of analytical and mathematical procedures that aid in the selection of a course of action from various alternative approaches. What is GCP? Good clinical practice What is safety reporting? Must report ALL effects within 15 days What is cross-over design? Subject receives different treatments through the course of time. What is a factorial trial? Used to test medicines in combination First group tests therapy A The second group tests therapy B What is a non-inferiority trial? testing to see if treatment is not worse than another What is an adaptive clinical trial? Can change things mid-trial 2/2