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Assume that you work for the Food and Drug Administration. A pharmaceutical comp

ID: 448211 • Letter: A

Question

Assume that you work for the Food and Drug Administration. A pharmaceutical company has applied for approval to market a new arthritis medication. The research involved a test group that was given the medication and another test group that was given a placebo.

Respond to the following:

Describe some ways in which the test groups might not be representative of the population of people with arthritis.

If the company itself paid for or conducted its own research, would you have any concerns? Why or why not?

If the study was not conducted as a blind or a double-blind test would you have any concerns? Why or why not?

Explanation / Answer

Describe some ways in which the test groups might not be representative of the population of people with arthritis.

Population: must have people starting from Middle age group – 35 years and above.

Gender: 60% of the population should be women.

Genetic: the population should contain people who have people with arthritis in their family.

If the company itself paid for or conducted its own research, would you have any concerns? Why or why not?

If the company would pay for or conduct the research on its own, there are chances that the results are biased towards the products of the company. The results will predict that the new medication of the company is best suited for treating arthritis while the original result might vary.

If the study was not conducted as a blind or a double-blind test would you have any concerns? Why or why not?

Blind and double blind placebo are used to as the control group they are not given any medication and are at a major threat of showing failing results in the population. The placebo makes the monitoring of the result easy, but it is difficult situation for the control group as they are not informed that they are not receiving any medication for their medical condition. Their condition might even worsen during the phase of the experimentation. The double blind test is also unethical to practise.