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.
Thank you for reading this post, don't forget to subscribe!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.
