Biostatistical Protocol & Analysis Plan Reviewer
Review biostatistical protocols for regulatory compliance and methodological rigor
What You Can Do
Submit your statistical protocol, analysis plan, or biostatistical methodology, and receive a comprehensive peer review covering analytical validity, regulatory compliance, and methodological soundness. You'll get specific recommendations to strengthen your protocol before submission to regulatory authorities or implementation in your trial.
Features
Evaluates the soundness of your statistical methods, assumptions, and approach against best practices in biostatistics and the specific context of your study design.
Cross-references your protocol against FDA, EMA, ICH-GCP, and other regulatory requirements to identify gaps before submission.
Validates your power calculations, sample size assumptions, and effect size justifications; flags inadequate or unsupported determinations.
Reviews primary and secondary endpoint definitions, statistical methods, adjustment strategies, and subgroup analysis plans for consistency and appropriateness.
Identifies missing specifications, internal inconsistencies, and omissions in protocol design that could delay regulatory review or approval.
Highlights potential statistical pitfalls, multiplicity issues, missing assumptions, and edge cases that could compromise trial validity or regulatory acceptance.
Evaluates how well statistical methods are described for regulatory submission and suggests refinements to strengthen the rationale.
Contextualizes your approach against industry precedent for similar therapeutic areas, study phases, and regulatory pathways.
Example Output
Example 1: Protocol Review Output
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🔴 Critical Gap: Power analysis cites 80% power at α=0.05 but does not justify the assumed effect size (Cohen's d = 0.5). Recommend: Provide clinical justification or sensitivity analysis across d ∈ [0.3, 0.8].
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🟡 Compliance Flag: Multiplicity adjustment strategy missing. With 3 primary endpoints, recommend pre-specifying Bonferroni or hierarchical testing to maintain family-wise error rate at 0.05.
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✅ Strength: Randomization scheme (1:1 stratified by site) is clearly documented and appropriate for this pragmatic trial design.
Example 2: Analysis Plan Review
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⚠️ Method Inconsistency: ITT population defined as "all randomized patients with baseline data" but missing-data handling strategy defers to per-protocol subset. Clarify: Will primary analysis be ITT with imputation, or PP with sensitivity check?
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🟢 Recommendation: Add pre-specified subgroup interactions (age, baseline severity) tested at α=0.10 to support hypothesis generation for follow-up trials.
Example 3: Regulatory Compliance Summary
✓ Aligns with FDA Complex Clinical Trial Guidance on adaptive design monitoring. ✗ Add Type I error control plan for interim analyses (current protocol silent on stopping rules). ✓ Sample size justification supported by prior literature and pilot data.
What's Included
- Comprehensive Review Checklist: Structured assessment of protocol completeness, statistical methods, assumptions, and regulatory alignment across 15+ dimensions.
- Regulatory Compliance Assessment: Detailed mapping to applicable regulatory frameworks (FDA, EMA, ICH-GCP) with identified gaps and corrective suggestions.
- Statistical Validity Report: In-depth critique of study design, power analysis, analysis methods, and control of statistical error rates with quantitative feedback.
- Prioritized Recommendations: Ranked list of actionable improvements, flagged by severity (critical, high, medium, low) with implementation guidance.
- Risk & Assumptions Log: Identification of statistical assumptions, potential pitfalls, and sensitivity analyses needed to strengthen trial robustness.
- Benchmark Comparison: Context on how your approach compares to precedent in your therapeutic area and regulatory pathway.
Who It's For
- Biostatisticians
- Clinical Trial Managers & Sponsors
- Regulatory Affairs Specialists
- Principal Investigators & Protocol Developers
- Clinical Research Scientists
Best For
- Pre-submission protocol reviews (IND, BLA, NIST)
- Analysis plan validation before trial initiation
- Regulatory compliance gap analysis
- Methodology rigor and soundness assessment
- Quality control of protocols across multi-site trials
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