Conducting research in human beings, even in small trials, is a serious business. No trial can proceed — even one in a single hospital center with just 30 patients — without a so–called clinical protocol. A protocol is essentially a detailed description of every aspect of the study:
- The purpose of the study
- The type of patients to be entered
- How patients are to be treated and evaluated, etc.
Much of the protocol consists of background information and regulatory boilerplate. The protocol writer must search far and wide for the information to assemble a complete document.
Clearly, developing a clinical protocol is not an easy task. Protocols for even small studies can run from 20 to 100 pages in length and can takes weeks, if not months to complete. Often the sheer labor required in writing a protocol significantly delays, and sometimes derails an important study, even when funding is available. In some cases, the protocol will be incomplete and poorly conceived, resulting in sub–standard data unworthy of publication.