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21 December, 16:08

46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

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  1. 21 December, 17:45
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    The investigador should: Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

    Explanation:

    An investigator's ethical duty, is to keep the subject of investigation, well informed with all the details about the invesigation. At a phase 2 of the study the subject suposposedly has been informed of the prosedure, following the informed consent. So in this particular case the investigator has to present all the new information so the subject can decide for himself what is best for him.

    During phase II of an investigation, it is necessary to evaluate the benefits or negative aspects of a drug, to ensure the safty and wellbeing of the subject. If a drog is known to harm a subject, the procedure would stop. In this phase is important to have the data to decide and discuss what is best for the subject.
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