A clinical drug trial is conducting a study of pharmacokinetics and safety of a drug in healthy individuals. The nurse will assist enrollment of participants into the next phase of the study and will include which subject?
Healthy and ill subjects
Subjects with other diseases
Subjects with disease the drug will treat
Healthy subjects
The Correct Answer is C
A. Phase I trials focus on healthy individuals, but the next phase (Phase II) involves patients with the target disease. Including both healthy and ill subjects at this stage is not appropriate.
B. Subjects with other diseases are not included in Phase II trials because the goal is to test the drug in individuals who have the specific condition the drug is intended to treat.
C. Phase II clinical trials focus on evaluating the drug’s efficacy and safety in individuals who have the disease it is designed to treat. This phase helps determine the optimal dosage and potential side effects in the target population.
D. Healthy subjects are included in Phase I trials to assess safety and pharmacokinetics, but in the next phase (Phase II), the study shifts to testing the drug in patients with the disease it is meant to treat.
Nursing Test Bank
Naxlex Comprehensive Predictor Exams
Related Questions
Correct Answer is D
Explanation
A. Assessment involves gathering data about the patient’s condition, but in this case, the nurse and patient are making a decision about discharge criteria, which falls under planning.
B. Evaluation occurs after interventions have been implemented to determine whether goals have been met. Since the patient has not yet attempted self-care, this phase has not been reached.
C. Implementation refers to carrying out nursing interventions, such as administering medications or assisting with breathing exercises. The discussion about discharge criteria is a planning activity rather than an intervention.
D. Planning involves setting goals and determining the criteria for discharge, which is what the nurse and patient are doing by establishing that the patient may go home when self-care can be performed without dyspnea or hypoxia.
Correct Answer is C
Explanation
A. Phase I trials focus on healthy individuals, but the next phase (Phase II) involves patients with the target disease. Including both healthy and ill subjects at this stage is not appropriate.
B. Subjects with other diseases are not included in Phase II trials because the goal is to test the drug in individuals who have the specific condition the drug is intended to treat.
C. Phase II clinical trials focus on evaluating the drug’s efficacy and safety in individuals who have the disease it is designed to treat. This phase helps determine the optimal dosage and potential side effects in the target population.
D. Healthy subjects are included in Phase I trials to assess safety and pharmacokinetics, but in the next phase (Phase II), the study shifts to testing the drug in patients with the disease it is meant to treat.
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