1 | To verify: | 10–20 | Source of antibody and dilution |
1. Specificity of antibody and assay technique | Technical details |
2. Cellular localisation of expression | Nature of samples |
3. Expression changes in tumour cells compared with normal cells | Pattern of expression changes |
2 | To investigate the prognostic significance of markers in samples from a single institution | 50–300 | Details of scoring system |
Cut-offs for log-rank test of survival and their justification |
Type of survival (disease-free or overall) correlation |
Univariate and multivariate HR, 95% CI, p value |
Kaplan–Meier plot |
| Meta-analyses of mPhase 2 studies to determine markers that show evidence and potential strengths as prognostic markers | ⩾10 studies | Inclusion and exclusion criteria |
Details of meta-analysis results |
Effects of assay technique, cut-off |
Potential for publication bias |
Overall strength of HR and significance |
3 | To validate the significance of best candidate markers in phase III clinical trials with tumour samples of limited availability | 00s–000s | Demographics of studied patients compared towith patients in the overall trial patients |
Results of univariate and multivariate survival analysis results |
4 | To test prospectively the performance of markers in phase III randomised clinical trials by incorporating markers as stratification factors | 00s–000s | |