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clinical trial

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Exam of 19 pages for the course clinical trial at clinical trial (clinical trial)

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QUESTION 1
The margin of error is always greater than or equal to the standard error.

True

False

3.4 points
QUESTION 2
A clinical trial is being conducted in order to determine the efficacy of a new drug used to treat Rheumatoid
arthritis. The efficacy of the medication will not only be determined by the physical improvement of
symptoms but also by using a blood test to examine the concentration C-reactive protein (an inflammatory
marker) in an individual’s blood. If the researcher wants a margin of error for the level of C-reactive protein
to be less than or equal to 3.0 mg/dL, and if the standard deviation for C-reactive protein concentrations
among arthritis patients was previously documented at 8 mg/dL, how many patients should be recruited for
each group in the study assuming a 95% confidence interval will be used to quantify the mean differences
between the control group and the treatment group?
n
for the treatment group = 112; n for the control group = 111

n
for the treatment group = 56; n for the control group = 57

n
for the treatment group = 55; n for the control group = 55

n
for the treatment group = 112; n for the control group = 112


3.4 points
QUESTION 3
It is important for researchers to account for attrition or loss of participants during follow-up.

True

False

3.4 points
QUESTION 4
When performing a Mann-Whitney U test, one should always use the higher value of the calculated U values
to compare to the critical U value while making the decision rule.

True

False

3.4 points
QUESTION 5
A researcher decides to take a random sample of the population and determine the ALT levels of the
population, which fall on a continuum. A bar chart would be useful in determining if the ALT levels of the
population are normally distributed.

, True

False

3.4 points
QUESTION 6
Which of the following individuals is likely to be excluded from a clinical trial?
An individual with other diseases besides the disease of interest.

An individual whose data is considered to be an outlier.

An individual of who is considered to be a minority.

An individual who will have difficulty complying trial protocols.


3.4 points
QUESTION 7
A researcher notes that there seems to be a difference in the prevalence of high blood pressure among
college-educated individuals who consume low amounts of processed foods and the prevalence of individuals
who only have a high school education and consume high amounts of processed foods. Use the appropriate
hypothesis to test for the independence of the two independent variables presented here at the 5%
significance level to ensure confounding has not influenced the study’s results. Then, interpret your response.

Diet Low in Processed Foods
Normal BP High BP Total
College
124 55 179
Education
High School
69 152 221
Education
Total 193 207 400
Diet High in Processed Foods
Normal BP High BP Total
College
64 85 149
Education
High School
98 153 251
Education
Total 162 238 400
The chi square value of 37.724 is higher than the chi square value of 3.84; therefore,
we do not reject H0 at the 5% level and reject H1, which states that level of education
and the amount of processed foods in an individual’s diet are not independent of one
another.
The chi square value of 37.724 is higher than the chi square value of 3.84; therefore,
we do not reject H0 at the 5% level and reject H1, which states that level of education
and the incidence of high blood pressure are not independent of one another.
The chi square value of 37.724 is higher than the chi square value of 3.84; therefore,
we can reject H0 at the 5% level in favor of H1, which states that level of education
and the incidence of high blood pressure are not independent of one another.

, The chi square value of 37.724 is higher than the chi square value of 3.84; therefore,
we can reject H0 at the 5% level in favor of H1, which states that level of education
and the amount of processed foods in an individual’s diet are not independent of one
another.

3.4 points
QUESTION 8
If a test is run and p = 0.0356, then we can reject H0 at  = 0.01.

True

False

3.4 points
QUESTION 9
The sample size required to detect an effect size of 0.25 is larger than the sample size required to detect an
effect size of 0.50 with 80% power and a 5% level of significance.

True

False

3.4 points
QUESTION 10
In logistic regression, the predictors are dichotomous, and the outcome is a continuous variable.

True

False

3.4 points
QUESTION 11
Researchers use active-controlled trials to test new medications that are used to treat a particular illness
against old medications used to treat the same illness.

True

False

3.4 points
QUESTION 12
Assume a doctor uses a specific form of mesh to repair all hernias in his hernia patients. The makers of the
mesh found there was an error that occurred while making the mesh, and the hernia mesh has a 45% chance
of failure. The doctor has treated 7 patients with the mesh so far; thus, the probability that the mesh does not
fail in all seven patients is .0152.

True

False

3.4 points
QUESTION 13
A researcher wants to compare the mean concentration of two medications considered biologically
equivalent, i.e., two medications that are able to produce the same therapeutic effect at the same level of

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