Better quality studies through review of protocols

The importance of a protocol is well recognized by scientists whose work is governed by good laboratory practices. Epidemiologists have used protocols for many years but have not always reaped the full benefits. Until relatively recently, there has been little consensus among epidemiologists about what constitutes a good protocol and, consequently, expectations of the pre-study review process may not be fulfilled. This paper examines some of the benefits to be derived from a good protocol and the importance of prestudy review. Our experience suggests that peer review cannot substitute for a competent principal investigator supported by a strong study management team. If such a study management team exists, the most important contribution of the external peer reviewer should be to ensure the impartiality of the study.