Table 2
Proposed multiphase evaluations of immunohistochemical prognostic markers
| mPhase | Objectives | Suggested sample size | Data to include in publication |
|---|---|---|---|
| CI, confidence interval; HR, hazard ratio. | |||
| 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 | |
