Question

A 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?
(A) Tell the subject about the new drug but discourage him from switching treatment until the study is completed.
(B) Withhold this 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 investigational drug and commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.
(D) Don't tell the subject about the new drug since phycian have the right to try our new treatments with their new 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 investigational drug and commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.