How clinical research works
Clinical trials are studies in people that look at new ways to prevent, detect, or treat disease. The aim of clinical trials is to determine if a new test or treatment works and is safe before it is approved by regulatory authorities and made available for use by doctors. Clinical trials vary in their primary goal or endpoint (i.e. the most important outcome of the trial), the number of patients involved, and the specifics of the study design. However, all clinical trials conform to Good Clinical Practice (GCP) and Guidelines set forth by the International Conference on Harmonisation and to a strict set of criteria outlined in a trial protocol. A protocol is a document that describes how a clinical trial will be conducted and ensures the safety of the trial participants and integrity of the data collected.