ABSTRACT
Before you can conduct a study, you must have a protocol-a written, detailed PLAN for how the study will be conducted and analyzed. Protocols are developed and written in a variety of ways and are rarely individual efforts. The author(s) must determine what information is known and what has been discovered by previous trials. In the development of a new drug by a sponsor, there is usually an overall drug development plan for the drug, and the content of the protocol is largely determined by that plan. Other elements to consider are as follows:
• What study design(s) should be used (parallel, crossover, “washout,” “lead in,” single blind, double blind, open label)?
