A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?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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10-12-2022
Medicine

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A 46-year-old man is currently enrolled in a phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?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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tutorconsortium631 tutorconsortium631 · Answer 1 · 2022-12-15T23:42:10+01:00

After weighing the advantages and disadvantages of the investigational drug and the drug that is currently on the market, the subject is given the option of continuing the research or switching to the experimental drug.

What does the term "investigational drug" mean?

An investigational drug, often known as an experimental drug, is being tested to discover if it can treat your illness or condition. Clinical studies are being used by scientists to determine the drug's safety and efficacy.

When are experimental medications appropriate for use?

Before a therapy IND can be issued, the following four conditions must be satisfied: 1) There is no adequate alternative treatment available; 2) The medicine is meant to treat a serious or immediately life-threatening condition.

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