Rare Diseases Global Coalition to Spur Development of Cures for Rare and Deadly Diseases
Global Coalition for Adaptive Research (GCAR), a nonprofit charitable organization announced its official launch. The Coalition is comprised of some of the world’s foremost clinical, translational and basic science investigators working collectively to help speed the discovery and development of cures for rare and deadly diseases.
Lexington/USA — As its first priority, GCAR will serve as the official sponsor of GBM Agile, an adaptive platform trial for patients with glioblastoma (GBM) — the most common and deadliest of malignant primary brain tumors.
Dr. Brian M. Alexander, GCAR president and chief executive officer believes that the Coalition's dedication to the advancement of science through innovative trial design would ultimately result in better treatments and drive rapid progress in order to make a real difference in patients’ lives. Their first effort seeks to improve treatment options for patients with glioblastoma — of which there is no known prevention or early detection methods, few available treatment options, and no cure.
GCAR will first aim to operationalize GBM Agile, a platform trial to identify new and effective therapies for glioblastoma. In addition, it will work to create a repository of clinical, safety and biomarker data from GBM patients to serve as an important tool for further understanding of this deadly disease. Finally, GCAR, using GBM Agile as a model for the efficient evaluation and development of therapies and biomarkers, will build additional platform trial collaborations to support the evaluation of drugs for rare and deadly diseases.
GBM Agile Overview
GBM Agile is an international, seamless Phase II (efficacy and safety)/Phase III (confirmatory) trial designed to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma. The goal is to identify effective therapies and the most promising biomarker-defined populations for those therapies in patients with glioblastoma. GBM Agile is a flexible and adaptable approach that allows researchers to study the effects of multiple treatment options simultaneously. Furthermore, new treatments and biomarkers can be added after the trial has started, creating a learning system in perpetuity.