ABSTRACT
Choosing the study question is the critical step when initiating a research project. Hulley suggested the following criteria (FINER) for choosing a
good study question (1):
Feasible in terms of resources, expertise, etc. Interesting to the investigator Novel: ideally the question should generate new data or confirm or
refute earlier findings
Ethical Relevant The randomized, controlled trial (RCT) is now considered the ideal
proving ground for new treatments. RCTs must have sufficient power to
detect a clinically important difference in outcome between patients receiv-
ing the experimental treatment and controls receiving standard treatment
only. Strict methodological rules must be followed, and many of them are
described in this chapter. As an introduction to the conduct of RCTs, however, several major points must be emphasized.
