Every company has a “Phase III heartbreak.” The molecule looked perfect-mechanism sound, safety profile strong- but the primary endpoint missed. Most teams bury the data. At Octavus Consulting, we treat it as a gold mine.
The Opportunity in Failure
Clinical failures hold information about trial design, recruitment, and patient heterogeneity that can redefine the next success. One biotech we advised saw its rheumatoid-arthritis study fail spectacularly. Instead of shelving the asset, we performed a Trial Autopsy: re-simulated power, identified subgroup response patterns, and found that patients with early-stage disease responded twice as well. A smaller, adaptive follow-up trial confirmed efficacy-and revived investor confidence.
The Octavus Trial Autopsy Framework
Design Review: Evaluate endpoints, visit schedules, and inclusion/exclusion logic against real-world patient behavior.
Execution Audit: Examine site performance, screen-failure rates, and protocol deviations.
Statistical Re-simulation: Re-run power using observed variance; test alternative endpoints.
Subgroup Discovery: Use machine learning to detect covariates influencing response.
Integration with RWE: Validate findings across external datasets.
Culture Change: Normalize Learning
Companies must destigmatize failure. When every negative outcome is viewed through a scientific lens, portfolios evolve faster. Trial Autopsies should be standard within 60 days of database lock.
Long-Term Benefits
- Design efficiency: Fewer amendments in future trials.
- Investor confidence: Transparency demonstrates discipline.
- Pipeline optimization: Resources flow to the most promising indications.
What to Do Next
Select one failed or stalled program. Conduct a structured autopsy using the five-step model. Document what worked, what didn’t, and what can be rescued.
Failure only wastes value when ignored.
Reach us at bd@octavusconsulting.com to operationalize trial-failure analytics.
