Sunday, February 22, 2026

From "Two-Trial Dogma" to the Single Pivotal Standard: The Evolution of FDA Evidence Requirements

›
The "two-trial" rule was born from the 1962 Kefauver-Harris Amendment to the Federal Food, Drug, and Cosmetic Act , which mandate...
Monday, February 16, 2026

The Statistical Magic Trick: How Trials Share Results While Staying Blind

›
  In the world of clinical research, "breaking the blind" is typically a cardinal sin. Yet, high-stakes Phase 3 trials like ORIGIN...
Sunday, January 18, 2026

Maximal Tolerated Dose (MTD) to Recommended Phase 2 Dose (RP2D) - a shift in early oncology trial designs

›
 As the field of oncology moves from systemic cytotoxic chemotherapies to targeted agents and immunotherapies, the paradigm for dose selecti...
Sunday, January 04, 2026

Excessive number of clinical trial protocol amendments due to complex trial design

›
In a previous blog post "Protocol amendment in clinical trials", I discussed the impact of protocol amendments on the clinical tri...
2 comments:
Thursday, January 01, 2026

One-way versus two-way tipping point analysis for robustness assessment of the missing data

›
Tipping point analysis (TPA) is a key sensitivity analysis mandated by regulatory agencies like the FDA to assess the robustness of clinic...
Monday, December 29, 2025

FDA guidance "Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies"

›
Earlier this month, FDA issued its guidance " Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND an...