What should an investigator do if a new beneficial drug becomes available during a clinical study?

When a new beneficial drug becomes available during a clinical study, the appropriate action for the investigator is to discuss options with the subject regarding their treatment. This approach is essential because it respects the autonomy and informed consent of the participants. The investigator has an ethical obligation to provide participants with all relevant information that could significantly impact their health and treatment choices.

By engaging in a discussion, the investigator can explain the potential benefits of the new drug, its risks, and how it may compare with the treatment the subject is currently receiving. This collaborative dialogue empowers the subject to make an informed decision about whether to switch to the new drug or continue with the current study protocol. Involvement in this decision-making process reinforces the principles of good clinical practice, ensuring that the participants' rights and well-being are the top priority.

In contrast, merely notifying the subject to terminate their participation does not address their treatment options adequately and could lead to a loss of trust. Keeping the information confidential or providing the information without discussion lacks transparency and could hinder the subject’s ability to make informed choices about their health. Thus, discussing options is the most ethical and responsible course of action.