B4 Wk1 BSE Basic/Clinical Research

Term for a seemingly inactive substance or treatment that contains no active therapeutic ingredients and has no direct medical affect

Placebo

What are placebo treatments used for?

Eliminate bias that may arise from expectation that a treatment should produce an effect

Which group is the one that receives the treatment?

Experimental group

Which group is the comparison group that does not receive treatment?

Control group

Which study type is when the participants are unaware of whether they are receiving the experimental treatment or a placebo?

Single blind study

Which study type is when BOTH participants and researchers are unaware of the treatment given until after the study is completed?

Double blind study

Which study type is when participants, researchers and analysts are unaware of which treatment each participant recieves?

Triple blind study

Term for systematic influence or error that can affect the research process and lead to incorrect or distorted results or conclusions

Bias

What is the term for NEW cases of a disease, injury, or death in a study population during a specified period?

Incidence

What is the formula for incidence?

New cases during a time period/population at risk

What is the number of people in a defined population with a specified disease or condition at a given point in time?

Prevalence

What is the formula for prevalence?

All existing cases (old+new)/total population

What type of research is this example: identify a molecular pathway involved in alzheimer’s

Basic/biomedical

What type of research is this example: test whether a therapeutic drug/devise or surgical procedure improves patient outcomes

Clinical

What type of research is this example: measure hypertension prevalence and associated risk factors

Epidemiological/population

What are the two types of clinical research?

Observational and Experimental

In experimental research, what is the difference between randomized and non-randomized?

Non randomized= NOT randomly assigned to experimental vs control group.

What is the importance of randomization?

Helps distribute known/unknown confounding factors and reduces selection bias, which strengthens internal validity

Which phase of a clinical trial tests the drug in a lab animal and in vitro experiment?

Pre-clinical phase

Which phase of a clinical trial is when a very small dose is given to 10-15 people?

Phase 0

Which phase of a clinical trial is performed in a group of 15-30 people that gives a small dose to a few people where a safety assessment via increasing doe to determine the maximum tolerable dose (dose range) is performed?

Phase I

Which phase of a clinical trial recruits 5-100 subjects to examine the effective dosage and safety issues?

Phase II

What is the difference between PhaseIIA and Phase IIB in clinical trials?

A tests dosing requirements, while B tests the efficacy

Which phase of a clinical trial recruits 300-3000 subjects and compares the test drug with a placebo drug to observe improvement? Adverse reactions are noted.

Phase III

What is the difference between phaseIIIA and phase IIIB?

A gets sufficent/significant data, while B allows patient to continue treatment

When may a drug be approved by the FDA?

After phase III

Which phase of a clinical trial occurs after approval/post-licensure and follows up on patients for a long time for potential adverse reactions and drug-drug interactions?

Phase IV