Health Research and Policy

Abstract

DATE: October 3, 2013
TIME: 1:15 - 3:00 pm
LOCATION: Medical School Office Building, Rm x303
TITLE: Use Phase 2 Interim Analysis to Speed Up Drug Development Decisions
SPEAKER: Jenny Huang, Associate Director
Genetech Research and Early Development (gRED), Oncology Biostatistics, Roche/Genetech

Drug development has become increasingly expensive, and time and risk are two of the key factors that affect the cost of drug development. Typically decisions regarding the further development of a molecule of interest in phase 3 trials are gated on phase 2 trial results. Better analytic approaches for Phase 2 data that can decrease the time to the ‘Phase 3 go’ decision and speed up the phase 3 development would improve oncology drug development with substantial gains.

We propose to systematically conduct interim analysis in phase 2 clinical trials and use the interim progression free survival (PFS) Hazard Ratio (HR) to facilitate drug development decisions via Monte Carlo simulations. As a reality check, we applied our methods to 35 historical Roche/Genentech phase 2 and phase 3 oncology trials and looked into the consistency in the ''phase 3 go'' decision between the interim and final analysis.

Suggested readings:
DiMasi JA, Feldman L, Seckler A, Wilson A. Trends in risks associated with new drug development: Success rates for investigational drugs. Clin Pharmacol Ther 2010; 87(3); 272-77.

Li, L., Evans, S., Uno, H., and Wei, L.J. (2009). Predicted Interval Plots (PIPS): A Graphical Tool for Data Monitoring of Clinical Trials, Statistics in Biopharmaceutical Research, 1(4), 348-355.

Hurvitz SA, et al. Phase II Randomized Study of TRastuzumab Emtansine Versus Trastuzumab Plus Docetaxel in Patients With Human Epidermal Growth Factor Receptor 2 – Positive Metastatic Breast Cancer. J Clin Oncol, 31 (9):1157-1163, 2013.

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