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Re-inventing drug development: A case study of the I-SPY 2 breast cancer clinical trials program

Sonya Das1, Andrew W Lo2

  • 1MIT Laboratory for Financial Engineering, Sloan School of Management, Cambridge, MA, United States; MIT Department of Mathematics, Cambridge, MA, United States.

Contemporary Clinical Trials
|September 14, 2017
PubMed
Abstract

Insights

The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And molecular anaLysis 2) offers a novel model for efficient drug development. Its adaptive design and collaborative approach accelerate therapeutic discovery for breast cancer and potentially other diseases.

Area of Science:

  • Oncology
  • Clinical Trial Design
  • Pharmacology

Background:

  • The I-SPY 2 TRIAL (Investigation of Serial studies to Predict Your Therapeutic Response with Imaging And molecular anaLysis 2) is a unique breast cancer clinical trial.
  • Launched in 2010, it involves 20 leading US cancer centers and aims to reengineer drug development for efficiency and patient-centeredness.
  • This case study examines its potential as a drug development model for other disease areas.

Purpose of the Study:

  • To profile the I-SPY 2 TRIAL and assess its innovative features.
  • To evaluate its potential as a model for efficient and patient-centered drug development.
  • To explore the applicability of its adaptive design and collaborative framework to other therapeutic areas.

Main Methods:

  • Interviews with I-SPY leadership.
  • Literature review of relevant publications.
  • Case study analysis of the I-SPY 2 initiative.

Main Results:

  • Six drugs have successfully graduated from I-SPY 2, identified as candidates for phase 3 trials.
  • I-SPY 2 trials are more efficient, involving fewer subjects and reaching conclusions faster.
  • Drug candidates show more than double the predicted likelihood of success in phase 3 compared to traditional trials.

Conclusions:

  • The I-SPY 2 TRIAL's adaptive design, precompetitive stakeholder network, and flexible infrastructure offer a template for efficient drug development.
  • These novel features can lead to more cost-effective and accelerated therapeutic discovery.
  • The model holds promise for improving drug development processes beyond breast cancer.
Keywords:
Adaptive trial designBayesian analysisBiomarkersBreast cancerPhase 2

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