Amol Akhade/hiranandanihospital.org
Aug 3, 2025, 19:32
Amol Akhade: Understanding the Hidden Rules of Trial Design
Amol Akhade, Consultant Medical Oncologist at Suyog Cancer Clinics, shared a post on LinkedIn:
“New Substack Essay
The Seduction of Significance: Understanding the Hidden Rules of Trial Design — Interim Analyses, Alpha, Power, and the “Split”
In oncology, trial results often hinge not on biology, but on design.
This post unpacks the hidden architecture of clinical trials:
- Why alpha isn’t always 0.05
- Why p < 0.05 may still not be significant
- How interim analyses inflate Type I error
- What happens when endpoints are tested without alpha protection
- And why nominal p-values can deceive
We walk through real-world examples from KEYNOTE-522, CheckMate-649, DESTINY-Breast04, SOLO1, and OLYMPIA, not just to explain statistics, but to challenge how we interpret trial success.
For fellows, clinicians, and researchers who want to read between the endpoints.
Read the full post on Substack.”
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Dec. 14-16, 2023
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