In February 2015, more than 130 global collaborators — researchers, clinicians, biostatisticians, patient advocates, and others — came together for a series of meetings to brainstorm new ideas. A protocol draft for GBM AGILE was developed and, working with the FDA, was revised and refined to yield a remarkable result. The GBM AGILE structure would have broad eligibility to maximize learning and participation, and the design would allow promising therapies to be quickly developed and approved by the FDA. GBM AGILE would also foster development of precision medicines by understanding which patients benefit most from experimental therapies based on their biomarker profile.
In April 2017, the Global Coalition for Adaptive Research (GCAR), a 501(c)3 not for profit corporation, was founded by Brian Alexander, Sujuan Ba, Web Cavenee, Tim Cloughesy, John Frishkopf, and Faramarz Yousefzadeh to be the Sponsor of GBM AGILE and “take the baton” to the implementation phase of this innovative, groundbreaking platform trial.
GCAR’s broader mission is to lead the development and ongoing management of clinical trial platforms to accelerate the discovery and development of cures for patients with rare and deadly diseases.