Therapeutic development includes the activities necessary to bring a new medicinal compound (chemical or biologic) or medical device to market. Following drug discovery or development of a new device, successful preclinical studies result in an Investigational New Drug (IND) application (United States only; Clinical Trials Exemption Certificate in the United Kingdom). Once the IND is filed, a team-driven process begins that tests the efficacy and safety of a new therapeutic in humans. This process, known as clinical development, has traditionally been divided into 4 phases, with large-scale phase 3 pivotal trials in patients with a specific disease leading to registration and postmarketing studies.1
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