What is a placebo-controlled study?
In a placebo-controlled study, participants are randomly assigned to receive either the investigational treatment or a placebo. The placebo resembles the treatment in appearance and administration but does not contain the active drug. This design helps isolate the true effect of the treatment by eliminating bias.
Why are placebo-controlled studies important in clinical development?
They are considered the gold standard for determining efficacy and safety. Placebo controls help ensure scientific validity, meet regulatory expectations, and support strong product differentiation. Ethical considerations must be addressed, particularly when effective standard treatments exist.
