The scientific method this is used to test associations. The process is to do research, come up with a question, hypothesize, and then test the hypothesis
Hypothesis this is a shorter, narrower idea when compared to a theory
Theory this is built upon a large amount of research to answer a larger ...
BBH 451 Exam 2 Test Questions and
Correct Answers
The scientific method ✅this is used to test associations. The process is to do research,
come up with a question, hypothesize, and then test the hypothesis
Hypothesis ✅this is a shorter, narrower idea when compared to a theory
Theory ✅this is built upon a large amount of research to answer a larger question, as
opposed to a hypothesis
P-value ✅a probability (less than 0.05 is statistically significant), but not proof itself.
Due to bias, confounds, and unknown factors, even statistically significant results might
lead to inaccurate inferences about causality
Dose response curves ✅these types of graphs that we have already talked about in
lecture give you a lot of power to make a conclusion. Gives you some hint of causation
No ✅does correlation imply causation?
Reverse causation ✅when b causes a
Bidirectional causation ✅a causes b and b causes a
Common causal variable ✅c causes a and b
Indirect (mediator) ✅a causes c, which causes b. But a didn't directly cause b
Causation ✅if there is correlation, there might be ______ and this is worth looking into.
If there is no _____, it's probably a waste of time to search for causation
Investigational new drug ✅what does ind stand for?
Investigational new drug ✅the fda gives permission to test the drug in people for the
first time. Fda must approve the study design and the safety precautions put in place by
the researchers
Pilot studies ✅a series of very small studies that happen after an application is sent to
the fda for an ind, but before the phases of clinical trials start
,Phase i ✅this phase of clinical trials looks into safety, toxicity, and side effects of the
drug
The drug is tested in healthy people and metabolism and excretion are measured.
Typical study n= 20-80 people
Phase 2 ✅this phase of clinical trials looks into efficacy and safety of the drug
To test for efficacy an intervention is created to produce the expected result under ideal
circumstances.
Drug is tested in disease populations. Requires placebo control (aka "usual care"
control)
N = dozens to 300 people
Phase 3 ✅this phase of clinical trials looks into the effectiveness (degree of beneficial
effect under "real world" clinical settings) of the drug and compares it against a standard
(an already existing drug on the market) and safety
Different doses are tested
N= several hundred to 3,000 people
Phase 4 ✅this phase of clinical trials is new and looks at post marketing analysis
(optimal use and safety).
Sometimes called post-market surveillance
This phase is being recognized as important due to ill effects showing up when truly
large numbers of people take the drug
14 years (6 for pre-trial research and 8 for trials) ✅on average, how long does the
whole process of getting a drug on the market take?
Efficacy ✅when a drug works in ideal circumstances
Effectiveness ✅when a drug works in "real world" settings
Preclinical data ✅data that is collected (via animal studies) before phases of clinical
trials begin. Data must be convincing about efficacy for treating disease to get approval
for the next phase.
Toxicity can be detected in this phase, but human and rodent metabolism have many
differences
, 20% ✅approximately what percentage of drugs acquired new black box warnings
postmarketing?
Randomized clinical trials ✅these types of trials are the best way to determine
causality. They involve experimental and control groups.
Preventive clinical trial ✅a type of clinical trial that tests to find ways to prevent
particular medical conditions or if people have them already, to prevent them from
reoccurring. Emphasis of these studies might be on medicines, vitamins/minerals, or
lifestyle changes
Therapeutic clinical trials ✅this type of clinical trial enrolls patients that already have a
condition that the drug is intended to treat, and the trial drug provides a specific
treatment to the patient
Between group clinical trial design ✅this type of design for a clinical trial has two or
more groups of subjects that are each being tested by a different testing factor (different
treatments) simultaneously
Each group only receives one treatment, not all of them
Within group clinical trial design ✅this type of design for a clinical trial is when all of the
participants are exposed to every treatment or condition
Between subjects ✅a group is interested in studying whether the administration of a
monthly medication is more effective when the drug is taken mid-month or at the
beginning of each month. They have one group of patients come in at the beginning of
the month and get a placebo, then come in at the middle of the month and get the drug.
They have another group of patients come in at the beginning of the month and get the
drug, then come in at the middle of the month and get placebo. At the end of the month,
they compare the groups to see which time of administration was more effective. What
type of design is this?
Random assignment ✅all subjects enrolled have an equal chance of getting into the
intervention arm of the study.
You want groups that are alike on average (prior drug history, ses, etc.) Because this
improves the ability to attribute difference between groups to the intervention
Blinding ✅this is when the assignment of treatment (experimental or control) is
concealed from participants, investigators, and data analysts. Called single, double, and
triple _____ referring to the number of groups from which the assignment is concealed.
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