What are preclinical and clinical studies?
Most medical research begins with studies in test tubes and animals to establish whether or not a technology is feasible enough to warrant further research and to establish a general safety profile. These types of studies are called preclinical studies and are generally conducted in a laboratory environment or animal treatment facility. Promising technologies may then be applied to human subjects. These types of studies are called clinical studies. Clinical studies are well controlled, usually involve only a select group of doctors, and participants must meet a specific list of requirements in order to participate. Data from clinical studies help doctors determine whether a new technology is safe, effective, and/or better than other technologies. Those technologies that are proven to be safe and effective in a clinical study may go on to receive FDA approval for use in the United States, which then extends the new technology to doctors and patients throughout the nation.