Once a drug clears preclinical testing, it is finally ready to be tried in humans — but the journey is still far from over. Clinical trials unfold in carefully planned stages, each designed to answer different questions about the medicine’s safety and effectiveness.
Phase I trials are the cautious first step, involving a small group of healthy volunteers (usually 20 to 100 people). Here, researchers focus on safety: finding the right dose, monitoring how the drug moves through the body, and watching closely for any side effects.
If the results are encouraging, the medicine moves into Phase II, where it is given to a few hundred patients who actually have the disease. This stage asks: does it work, and is it still safe? Promising treatments then graduate to Phase III, large-scale trials involving thousands of patients across multiple locations to confirm how well the drug works and uncover any rare or unexpected side effects.
Even after approval, the process continues with Phase IV, or post-market surveillance, where the medicine is monitored in the real world to ensure it remains safe and effective over the long term.