Author Question: Clients enrolled in a clinical drug trial are told that they might receive a placebo drug as part of ... (Read 52 times)

rl · **on:** Jul 23, 2018

Clients enrolled in a clinical drug trial are told that they might receive a placebo drug as part of a control group. A client asks the nurse what a placebo is. Which response by the nurse is the most appropriate?

1. A placebo is a substance that has no therapeutic effect.
2. A placebo is a similar drug that is safe.
3. A placebo is a drug that has been tested before.
4. A placebo is an over-the-counter drug.

Question 2

The nurse explains to the client that during the Food and Drug Administration (FDA) drug approval process, clinical investigators from many different medical specialties address concerns. What concerns are addressed?

1. Whether a New Drug Application (NDA) must be filed
2. The marketability of the drug
3. What the cost of the drug should be
4. Whether or not the drug is safe

ebe · **Reply #1 on:** Jul 23, 2018

Answer to Question 1

Correct Answer: 1
Rationale 1: A placebo is an inert substance that has no therapeutic effect and is used as a control.
Rationale 2: A placebo is not a similar drug
Rationale 3: A placebo is generally not another drug.
Rationale 4: A placebo is not an over-the-counter drug
Global Rationale: A placebo is an inert substance that has no therapeutic effect and is used as a control. A placebo is not a similar drug, generally not another drug, and is not an over-the-counter drug.

Answer to Question 2

Correct Answer: 4
Rationale 1: The pharmaceutical company files the NDA.
Rationale 2: The clinical investigators do not determine marketability of the drug.
Rationale 3: Clinical investigators do not determine the cost of the drug.
Rationale 4: Safety is determined by the FDA during the Investigational New Drug Application process.
Global Rationale: During the FDA drug approval process, clinical investigators address concerns on whether or not the drug is safe. Safety is determined by the FDA during the Investigational New Drug Application process. The pharmaceutical company files the NDA. The clinical investigators do not determine marketability of the drug or determine the cost of the drug.