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 A
Explanation
a) The six rights of medication administration—right patient, right medication, right dose, right route, right time, and right documentation—help ensure patient safety by reducing medication errors. This is a fundamental nursing practice to prevent adverse drug reactions, overdoses, or omissions.
b) Informed consent is important but is not directly related to the six rights of medication administration. It is typically obtained before administering high-risk medications or treatments.
c) While proper medication administration includes patient education, the six rights primarily focus on safety rather than the adequacy of information given.
d) The six rights do not focus on cost-effectiveness but rather on the accurate and safe administration of drugs.
Correct Answer is C
Explanation
a) Noncompliance due to cost might be a concern for some patients, but it does not directly relate to the sedative effects of the drug.
b) Deficient knowledge could be relevant if the patient is unaware of the potential sedative effects, but the immediate concern is more focused on the potential for injury due to sedation.
c) Risk for injury is the priority nursing diagnosis in this scenario because sedation can impair the patient's ability to perform tasks safely, increasing the risk for falls or other injuries. This is particularly important for elderly patients, who are more vulnerable to the sedative effects of medications.
d) Ineffective health maintenance refers to issues with ongoing health practices, but it is less directly related to the immediate risk posed by the sedative effects of the medication.
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