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Critical Questions for Clinical Trial Design

Critical questions that must be answered include:

1. Is the study designed in a way that patients will be interested in participation and investigators will be interested in participation?
2. Are the inclusion/exclusion criteria properly designed to enroll patients that will provide a fair test of the device/product to achieve the study outcomes?
3. Based on the inclusion/exclusion criteria and the number of centers included, will patient enrollment allow study completion in a reasonable time frame?
4. Is the primary outcome measure the best one for this clinical area?
5. How will the potential outcomes of this study determine the next step in device development?

Unfortunately, many principle investigators selected on the basis of their national prominence in their field have little training in clinical trial methodology, design or statistics, and are poorly equipped to assist with many of these questions. In other cases, while experienced, they are too busy to devote the time required to review the protocol in the detail required to provide proper guidance in study development.