Conducting a successful clinical trial

While the Randomized Clinical Trial (RCT) is one of many research designs, it is the most powerful design available to researchers for investigating the efficacy (i.e. producing the desired effect under very controlled, ideal conditions) and effectiveness (i.e. producing the desired effect under normal, practical conditions) of an intervention. Because the RCT is the design of choice whenever possible, but is also one of the most difficult designs to execute successfully, the following article offers tips gleaned from practical experience on several aspects of conducting a RCT. Some of the areas discussed are: often-overlooked aspects of writing a well-designed protocol, the importance of statistical consulting, strategies for good project personnel and subject management, the role of good public relations, developing a credible and useful budget, and strategies for improving record keeping and administrative efficiency. The article will be of particular interest to the principal investigator designing a RCT protocol and the project manager responsible for executing it.