According to the National Institutes of Heatlh, a clinical trial (also clinical research) is a research study of human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Read more from the National Institutes of Health.
The primary regulations that govern the conduct of clinical studies are included in the Code of Federal Regulations, Title 21 (21 CFR). Investigators at Kessler Foundation Research Center/KIR follow good Clinical Practices (GCP), which refer to the FDA regulations and requirements that must be complied with while conducting a clinical study
