Clinical Research for Beginners - The Importance of Planning

While the identification of the individual who said “Failing to plan is planning to fail!” is in doubt, the wisdom of the words is not especially in the context of undertaking clinical research. There appears to be a view in some quarters that collecting a set of data, for example on people with a particular condition, and carrying out a series of analyses to try to find something of statistical significance constitutes a scientific investigation - it does not! A clinical research study must have a clearly defined aim with a comprehensive plan including a statement of the population of interest, which data are to be collected, how they will be measured, by whom, when and with what, as well as details of how subjects are to be allocated to interventions (if any). The purpose of this article is to give an introduction to some of the issues involved in constructing such a plan. It is by no means a definitive guide and further details can be found in the reference list.