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?

Answer 1

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

Step-by-step explanation:

Informed consent refers to the process of getting permission from the clinical trial subject to conduct the required studies. Informed consent requires providing the subject with enough information about the trial, but also outside information that would allow the subject to make an informed decision about participating in the study or not.

In this case, the investigator should inform the subject about the new comercially available drug, and discuss the pros and cons of both the trial drug and the available drug, so the subject can make an informed decision about whether to continue or withdraw from the clinical research.