What happens when the clinical trial is over?

One of the most important things that happens when a clinical trial is completed is that researchers analyze the data. This often takes months. Then, analyzed data is presented to regulators and expert scientists within agencies such as the FDA in the US or the EMA in Europe, who evaluate the data for safety and efficacy. If the data shows the drug that was studied is safe and more effective than placebos or other treatments at treating a certain disease, the regulators formally approve the product, with or without requiring further studies to be conducted, and clear the way for the drug-maker to market the drug that was tested. While data is being evaluated, many clinical trial teams offer “extension periods” for patients that participated in the trial. The extension periods may allow people to continue accessing the potential new treatment until regulators make the final decision. These are usually voluntary.