Clinical trials are the last, crucial step for getting brain tumor treatments approved for patient use. Unfortunately, the success rate is low – only 34% of potential therapies make it through critical phase III trials. National Brain Tumor Society is committed to driving progress within the clinical trials process to increase the availability of new treatments.

Our Clinical Trial Endpoints Initiative is seeking to simplify earlier-stage trials, and thus accelerate the pace of potential brain tumor drug approvals. At the same time, we're exploring how to apply the concept of an "adaptive clinical trial" design to brain tumors. Adaptive clinical trials, particularly the I-SPY 2 model that has been delivering promising early results in the breast cancer field, offer hope to improve later-stage clinical trials.

Dr. Donald A. Berry, PhD, a leading biostatistician from MD Anderson Cancer Center, and one of the designers of the I-SPY 2 trial, has been supporting the National Brain Tumor Society in these early discussions. Dr. Berry notes that the advantages of the I-SPY 2 model include "the ability to stop assigning a therapy to... patients for whom it is offering no benefit... The design is great for patients in the trial, while at the same time accelerating drug development and making it more accurate."