Each week, we select a recently published Open Access article to feature. This week’s article comes from Statistics in Medicine and considers early phase dose‐finding trials in virology.
The article’s abstract is given below, with the full article available to read here.
Early phase dose‐finding trials in virology. Statistics in Medicine. 2021; 40: 240– 253. https://doi.org/10.1002/sim.8771, , .
Little has been published in terms of dose‐finding methodology in virology. Aside from a few papers focusing on HIV, the considerable progress in dose‐finding methodology of the last 25 years has focused almost entirely on oncology. While adverse reactions to cytotoxic drugs may be life threatening, for anti‐viral agents we anticipate something different: side effects that provoke the cessation of treatment. This would correspond to treatment failure. On the other hand, success would not be yes/no but would correspond to a range of responses, from small, no more than say 20% reduction in viral load to the complete elimination of the virus. Less than total success matters since this may allow the patient to achieve immune‐mediated clearance. The motivation for this article is an upcoming dose‐finding trial in chronic norovirus infection. We propose a novel methodology whose goal is twofold: first, to identify the dose that provides the most favorable distribution of treatment outcomes, and, second, to do this in a way that maximizes the treatment benefit for the patients included in the study.