Week 1 Flashcards
(281 cards)
Define single blind study
In a single-blind experiment, the participants do
not know whether they are receiving an
experimental treatment or a placebo
Definite double blind study
In a double-blind experiment, neither the
researchers nor the participants are aware of
which subjects receive the treatment until after
the study is completed
What is the goal of using a placebo?
Eliminate bias that may arise from the expectation that a treatment should produce an effect
B&E: What is Generalizability?
The extent to which the results of a study are
able to be applied to the population of people
that is comparable to the population studied
B&E: What is prevalence?
The number of existing cases of a disease in a
defined population at a specified time
B&E: What is incidence?
The number of new cases of a disease during a given period of time in a defined population
B&E: What is biomedical research?
- Perform scientific investigation
- Experiments
- Observing
- Analyses & Testing
- Find causes of the disease
- Normally wet-lab experiments
B&E: What is applied clinical research?
- Research that benefits humans
- Diagnosis, procedures, medications, devices
- Research effectiveness & safety
B&E: What is epidemiological research?
- Tracking diseases in large population
- Examine association of exposure with disease
What are the preliminary steps to research?
- Topic issue/interest
- Literature search
- Research goal
- Research design
- Data process
B&E: Contrast observational studies from experimental studies ?
- Observational: Don’t have control over exposure
- Experimental: Researchers control exposure & goal is to determine benefit of therapy
B&E: What are three features of a clinical trial?
- Control
- Randomization
- Blinding
B&E: Who is unaware in a triple blind study?
- Subjects, researchers, and data analysts are unaware of who is getting treatment or not
B&E: Describe the parameters of Phase 0 studies
- AKA Human micro-dosing studies
1. Gather preliminary data pharmacodynamics and pharmacokinetics
2. Gives no data on safety or efficacy
3. Small number of subjects (10-15) people
B&E: Describe the parameters of Phase I study
- Increase number of subjects (10-100)
- Designed to assess the safety, toxicity, tolerability, PK, PD, of a drug
- Dose ranging and dose escalation
B&E: Describe the parameters of Phase II studies
- Therapeutic exploratory trial
- Efficacy in patients
- Safety issues
- Optimum dose finding
- Often placebo-controlled and often blinded
B&E: How many persons comprise a phase II study?
Small quantity: 20-300 subjects
B&E: Describe the parameters of Phase IIA & Phase IIB studies
- Phase IIA: designed to assess dosing requirement
- Phase IIB: Designed to study the efficacy of a drug
B&E: What quantity of participants comprise Phase III studies?
- Large # of subjects: 300-3,000 subjects
B&E: What can happen after phase III studies?
Drug may be approved by the FDA
B&E: Describe the parameters of Phase III study
- Therapeutic confirmatory trials
- To establish the efficacy of the drug against existing therapy in a larger number of patients, methods of usage, etc.
B&E: Describe the Phase IIIA & Phase IIIB parameters for study
- Phase IIIA: To get sufficient and significant data
- Phase IIIB: Allows the patient to continue the treatment, label expansion, additional data
B&E: Describe the parameters of a phase IV study
- Post-marketing studies
- After the drug is on the market
- Involves safety surveillance
- Determine behavior of drug in real-life situations
- Evaluate action of drug in a situation of missed dosage or over dosage
- Monitor for long term affects
B&E: Describe how Basic Science and Clinical research differ in their aim/purpose?
- Basic Science: how does something work
- Clinical: aimed at likelihood of events being related or even correlated, humans involved research