Question

A 46-year-old man is currently enrolled in a Phase I 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?A) Tell the subject about the new drug but discourage him from switching treatments until the study is completed.B) Withhold this new information to avoid confusing the subject with other treatment options or alternatives.C) 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.D) Do not tell the subject about the new drug since phycians have the right to try out new treatments with their patients.

Answer 1

Answer:

C) 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.                            

Explanation:

               Phase I study of a drug is to determine the correct dose of a new drug to test its efficiency with the fewest side effects. Investigators used this study to a very small group of people to test its causes and effects. It is to test the safety of the drug.

            Now when a new drug is commercially available which can have an equal benefit to the subject or cab have greater benefit to the subject. In this case , the investigator must inform the patient or the subject about the drug and share all the information with him. He should also tell him the side effects and the positive effects of the drug on him. And then let allow the patient to decide whether to test the new drug or continue with the previous one.

Hence the answer is ---

C) 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.