The Ins and Outs of Clinical Trials

Abstract

Success as a clinical trials investigator requires medical expertise in the disease being studied, expertise in regulations surrounding human research, and meticulous compliance with study protocols and procedures. Knowledge of the disease being investigated empowers the investigator to ask questions that address unmet needs for that specific disease. The investigator must be familiar with the regulations surrounding human research in order to know whether he or she is in compliance with those requirements. The investigator must be ethical, unbiased, organized, and focused on details. A successful clinical trial results from team effort, and the principal investigator must me a motivating leader. Results of clinical trials are valid only if the subjects are appropriately selected to comply with inclusion criteria, the protocol is followed strictly, and the data is analyzed using relevant statistical methods. This chapter focuses upon these facets of becoming a successful clinical trials investigator.