Chapter·BiostatisticsRCTs

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1

A student is reviewing the various effects that can be plotted on a dose-response curve. He has observed that certain drugs can work as an agonist and an antagonist at a particular site. He has plotted a particular graph (as shown below) and is checking for other responses that can be measured on the same graph. He learned that drug B is less potent than drug A. Drug B also reduces the potency of drug A when combined in the same solution; however, if additional drug A is added to the solution, the maximal efficacy (Emax) of drug A increases. He wishes to plot another curve for drug C. He learns that drug C works on the same molecules as drugs A and B, but drug C reduces the maximal efficacy (Emax) of drug A significantly when combined with drug A. Which of the following best describes drug C?

AReversible antagonist

BCompetitive antagonist

CFull agonist

DInverse agonist

ENon-competitive antagonist

2

Researchers are studying the effects of a new medication for the treatment of type 2 diabetes. A randomized group of 100 subjects is given the new medication 1st for 2 months, followed by a washout period of 2 weeks, and then administration of the gold standard medication for 2 months. Another randomized group of 100 subjects is given the gold standard medication 1st for 2 months, followed by a washout period of 2 weeks, and then administration of the new medication for 2 months. What is the main disadvantage of this study design?

AHawthorne effect

BIncreasing selection bias

CIncreasing confounding bias

DDecreasing power

ECarryover effect

3

A researcher is trying to determine whether a newly discovered substance X can be useful in promoting wound healing after surgery. She conducts this study by enrolling the next 100 patients that will be undergoing this surgery and separating them into 2 groups. She decides which patient will be in which group by using a random number generator. Subsequently, she prepares 1 set of syringes with the novel substance X and 1 set of syringes with a saline control. Both of these sets of syringes are unlabeled and the substances inside cannot be distinguished. She gives the surgeon performing the surgery 1 of the syringes and does not inform him nor the patient which syringe was used. After the study is complete, she analyzes all the data that was collected and performs statistical analysis. This study most likely provides which level of evidence for use of substance X?

ALevel 3

BLevel 1

CLevel 4

DLevel 5

ELevel 2

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