We have created a suite of tools to support decision making in early clinical translation of biomedical science. We use a traffic light system to grade the validity of the evidence. We highlight areas of concern, where the evidence is robust and indicate where there are evidence gaps. Each tool is composed of several questions which aim to assess:
reporting of inter and intra assay variance
reporting of sample size and sample size calculations
use of multiple models/ teams to demonstrate a given result
clarity of methodological reporting
evidence that the model recapitulates the disease of interest (including grade or stage or heterogeneity)
evidence that the marker correctly identifies the target
evidence that the tissue sample(s) recapitulates the disease of interest (including grade or stage or heterogeneity)
clarity of methodological reporting
definition
consideration of controls and thresholds