In a clinical trial, can placebo be dropped if there is readily available standard treatment that could be life-saving?

• A. True
• B. False
• C. Only with prior consent
• D. Not applicable

Answer: (A)

When a life-saving standard treatment exists, withholding it by assigning participants to a placebo is unethical. Ethical trial design requires that all participants receive the best proven therapy or be given an active comparator, rather than a placebo, to avoid harm. Therefore, the placebo arm can be dropped or replaced with standard-of-care or an active control, and investigators may design the study so the new treatment adds on to standard therapy or is compared directly against it. Rescue therapy should be available if a participant worsens. This aligns with protecting participants’ welfare while still allowing scientific evaluation of the investigational treatment.