Clinical Trials

Clinical Trials: A Practical Guide ■❚❙❘Figure 1. The percentage of patients who experienced protocol-defined virological failure in each treatmentarm of the MaxCmin 1study.353025Percentage (%)20151050Indinavir/r(n = 158)Saquinavir/r(n = 148)Treatment armr = ritonavir.need to refer to the text for further information. The scale of the axes needs to beincluded, and the maximum and minimum values should be specified. A legendand footnote can also be added to a graph to increase clarity. Overcrowdingfigures with details should be avoided to eliminate any confusion in understandingthe graphical information.Example: MaxCmin 1trialIn this chapter, we will illustrate data from the MaxCmin 1clinical trial usingappropriate graphs. MaxCmin 1was a randomized clinical trial set up to comparethe safety and efficacy of ritonavir-boosted indinavir (IDV/r) versus ritonavirboostedsaquinavir (SAQ/r) in HIV-1-positive patients [4]. Out of the 306 patientswho initiated their randomized regimen, 80 experienced protocol-definedvirological failure (43 patients [27.2%] in the IDV/r arm and 37 patients [25.0%]in the SAQ/r arm) (Figure 1). In this basic graph, the two treatment arms appearon the x-axis and the outcome information (the percentage) is summarized onthe y-axis.409