Berry Consultants Transitioning from I-SPY Trials

Berry Consultants, LLC announced today that it is discontinuing its involvement in the I-SPY trials in neoadjuvant breast cancer. Beginning in 2009, Donald Berry, PhD, of Berry Consultants designed the I-SPY 2 trial in collaboration with trial PI Laura Esserman, MD. He has served as the trial's co-PI since that time. Berry Consultants has also provided substantial support to the trial, entirely without compensation, by creating software to fit the models for the adaptive design, monitoring the adaptive design algorithm evaluating the experimental therapies and response adaptive randomization, providing monthly reports for the trial's Data and Safety Monitoring Board, and modifying the trial design to accommodate the evolving standard of care in breast cancer.

I-SPY 2 has become the prototype for Bayesian adaptive platform clinical trials. It has adaptively randomized more than 2,000 women across control therapy and 24 experimental therapies from 17 pharmaceutical companies. Eight of these therapies met the criterion for graduation to phase 3 representing important new treatments for 6 of the 10 possible breast cancer biomarker signatures.

I-SPY 2 has now been re-envisioned as I-SPY 2.2. The new trial design represents a substantial departure from the prior design and approach. During this period of transition, Berry Consultants will aid the trials' sponsor, Quantum Leap Healthcare Collaborative, with matters related to I-SPY 2. However, Berry Consultants has chosen not to be involved in I-SPY 2.2.

As part of the transition, Berry Consultants provided Quantum Leap a license to utilize the software that was developed by Berry Consultants to implement the I-SPY 2 trial. This software incorporates programming for the many innovations introduced in I-SPY 2, including adaptive randomization by biomarker subtypes, the "time machine" that enables utilizing non-concurrently randomized controls, modeling interim MRI results and incorporating them into analysis of the trial's primary endpoint of pathological complete response, and the "dynamic control" that incorporates treatment regimens not investigated in the I-SPY 2 trial.

Scott M. Berry, PhD, President of Berry Consultants, commented: "I-SPY 2 has proven very important for delivering good therapies to breast cancer patients while efficiently investigating these therapies. The trial's contribution to medical research reaches far beyond breast cancer and other cancers and has had a major impact on the science of clinical trials. Berry Consultants has expanded on many of the innovations we introduced in I-SPY 2 in designing more than 30 Bayesian adaptive platform trials including treating such diverse diseases as COVID-19, Ebola, Alzheimer's disease, Duchenne muscular dystrophy, amyotrophic lateral sclerosis, and post-traumatic stress disorder."

About Berry Consultants
Berry Consultants is a statistical consulting company specializing in innovative clinical trial design, analysis, execution, and software solutions for the pharmaceutical and medical device industry, NIH cooperative groups, international consortia, and patient advocacy groups. Berry Consultants employs world-renowned Bayesian statisticians and clinical trialists. The company strives to set the standard for adaptive clinical trial design and analysis across all medical disciplines. www.berryconsultants.com