As the name implies, in observational studies one 'observes.' The choice of therapy is determined by the patient and her physician rather than protocol, and, because participation does not impact which treatment a patient receives, these studies can enroll a greater diversity of patients. As such, these studies are generally viewed as more 'real-world' than classic clinical trials. As the importance of these studies have grown, so have efforts to develop best practice guidelines in the design, implementation, and evaluation of these studies, so that high-quality evidence can be used for decision-making among regulators, payers, physicians, and patients.

Pharmaceutical Executive, September 2011, Vol. 31, No. 9