ABSTRACT
Randomized clinical trials are generally considered the foundation on which evidence-based medicine is built. In theory they are very simple: half of the patients receive standard treatment; half receive the new treatment; and the two groups are compared in terms of efficacy. But in practice they can actually be very complex. However, just because a trial is randomized does not guarantee its quality, and so the aim of this chapter is to highlight some of the pitfalls that can, and all too often do, exist in the design, conduct, and analysis of randomized trials. In this chapter we will work through a list of 10 key questions that may be a useful way of separating the gold standard randomized trials from the rest.
