Assay Sensitivity and Clinical Trials

When designing clinical trials, the study design must be robust. Decisions around the sample size, treatment duration, eligibility criteria, and randomisation and blinding must be made.

In addition to all these factors, assay sensitivity must be considered. Assay sensitivity refers to the trial’s ability to distinguish an effective treatment from a less effective (or ineffective) one. Many trials lack assay sensitivity, impacting one’s ability to formulate strong conclusions.