Glioblastoma Multiforme (GBM) is the deadliest and most aggressive form of brain cancer for which there is currently no cure. This often-fatal brain cancer accounts for 45% of all malignant brain tumors and 12,000 cancer diagnoses per year in the United States, in addition to tens of thousands more around the globe. The average GBM patient has a survival rate of one to two years.
Out of determination to improve outcomes for GBM patients, in June 2019, after years of collaboration the Global Coalition for Adaptive Research (GCAR) launched GBM AGILE – a global effort to defeat GBM through next-generation clinical trials. GBM AGILE was first conceived in 2015 by an international group of more than 130 clinicians, researchers, biostatisticians, imagers, pathologists, leaders from government and industry and patient advocates. National Foundation for Cancer Research President & CEO Dr. Sujuan Ba and many of its funded scientists have been a driving force of GBM AGILE from its initial conception to launch.
GBM AGILE (which stands for Adaptive Global Innovative Learning Environment) is an “adaptive” clinical trial. The standard clinical trials take three to seven years before seeing results, and they cannot be modified once they begin. Patients receive only one treatment and by the time results are produced the treatment protocol is already many years old. In contrast, adaptive trials are designed to be regularly updated. Ineffective treatments can be stopped early in order to be replaced with effective treatments. The goal is to allow GBM patients to quickly share in the benefits of more effective therapies, taking advantage of what some of them do not have: time.
“Developing new therapies for patients with GBM will require more engagement from industry and enhanced learning from clinical trials. Platform trials can accelerate the time from discovery in the laboratory to implementation in the clinic. GBM AGILE will raise the bar for all clinical trials,” said Janet Woodcock, M.D., Director of the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in a press release.
Instead of waiting several years in hopes of participating in small, standard trials, GBM patients will be able to benefit more quickly from treatment advances. GBM AGILE is designed to allow treatments to “Fail Fast” and “Correct Even Faster.” The advantages of adaptive clinical trials include greater responsiveness, flexibility, speed, rationality and participant incentives while still incorporating the three critical criteria that all clinical trials exist to ensure: safety, efficacy and improvement.
The FDA has been a strong proponent of bringing a faster clinical trial model to fruition with the use of master protocols, including platform trials, to support more efficient and less costly drug development.
GBM AGILE will open in over 40 academic medical centers and community-based institutions across the United States, with plans to expand across Europe, China, Canada, and Australia beginning in 2019 through 2020. Henry Ford Cancer Institute, one of Michigan’s largest cancer institutions, is the first clinical site for GBM AGILE and is now enrolling patients.