A cross-pharma working group led by Satrajit Roychoudhury of Pfizer proposes a combination test for robust design and analysis of clinical trials where non-proportional hazards are a possibility. The guidance includes a straw man proposal for practitioners, illustrated with a real-life example and simulation results. The dataset likely contains simulated trial data and analysis outputs supporting the proposed methodology.
Use Cases
- Evaluating the power of combination tests under different non-proportional hazard scenarios based on the described methodology.
- Comparing the efficiency of robust analysis methods against traditional log-rank tests for time-to-event data.
- Designing clinical trials with estimands like expected life gain, as suggested by the ICH E9 (R1) addendum referenced in the description.
- Simulating treatment effect outcomes under a variety of alternative hypothesis distributions mentioned in the paper.
Strengths
- Proposal is based on work from a cross-pharma industry working group, suggesting practical relevance.
- Methodology is illustrated with a real-life example, indicating applied validation.
Limitations
- Row count and dataset size are unknown, which may limit suitability assessment.
- Column-level documentation is absent; field semantics must be inferred after download.
- Last update date is unknown; freshness unverified.
Provenance
- Source
- Satrajit Roychoudhury (Pfizer) and a cross-pharma working group, via paperswithcode.
- Collection Method
- Likely generated from simulations and analysis of a real clinical trial example.