What should an investigator do if a new, potentially beneficial drug becomes available during a subject's participation in a clinical trial?

When a new, potentially beneficial drug becomes available during a subject's participation in a clinical trial, the investigator has an ethical obligation to prioritize the well-being and informed choice of the participant. Providing the subject with information about the new drug and discussing all available options allows the subject to make an informed decision regarding their care and participation in the trial.

This approach aligns with the principles of informed consent and respect for persons in research ethics, which require that participants be fully informed about any new developments that may affect their treatment. The investigator should provide comprehensive details about the new drug, including its benefits, risks, and how it compares to the treatment being studied in the trial. Having an open and thorough discussion ensures that the subject can weigh their options and decide what is best for them, which is crucial for maintaining trust and integrity in the research process.

Ultimately, this approach supports the autonomy of the participant, allowing them to actively engage in their treatment decisions rather than feeling sidelined or uninformed regarding developments that may impact their health.