Expediting Clinical Trial Processes to Advance Brain Cancer Research
Through multidisciplinary collaboration, Yoshie Umemura, MD, and colleagues were able to organize the Gliofocus trial in brain cancer relatively fast.
CancerNetwork® spoke with Yoshie Umemura, MD, about ongoing research efforts that her institution is organizing in the brain cancer field.
Umemura, the chief medical officer of the Ivy Brain Tumor Center, division chief of Neuro-Oncology, and the William and Joan Shapiro chair of Neuro-Oncology at Barrow Neurological Institute, highlighted a focus on the phase 3 Gliofocus trial (NCT06388733), in which she and co-investigators will evaluate treatment with niraparib (Zejula) for patients with newly diagnosed MGMT unmethylated glioblastoma. Additionally, she described how those at her institution have made use of a specific multidisciplinary collaboration at the Ivy Brain Tumor Center to advance their clinical trial efforts through each phase more quickly compared with traditional methods.
Transcript:
What we’re currently excited about is a phase 3 clinical trial that we are sponsoring. I’m the principal investigator at our site at the Ivy Brain Tumor Center, but as our institution, we’re sponsoring this international trial. [Although] we’re excited about the study itself, I think what’s most exciting is the way it happened. Phase 3 clinical trials often take years and years, sometimes over a decade, to [progress] from phase zero, phase 1, and phase 2 to phase 3. It takes forever. Even just opening one phase 2/3 study, from talking about the concept to getting it across to the starting line, can take years and years.
Because we have a unique platform where we try to take away some red tape safely [with] some of the multidisciplinary, creative minds that we have here, the platform was set [for us to] push from the early phase to the late phase quickly. We were able to move it just in a few years from phase zero and phase 2 to a phase 3 international trial. Having that platform and proving that we can make that happen is extremely exciting because it’s not going to be just one drug or one trial that’s going to make a difference. When there is one positive or negative trial, there are a lot of follow-up questions and follow-up trials. We can’t take 15 to 30 years to answer one simple question; we need to be able to do a lot of trials safely and effectively and have that platform to show that we can do this much quicker than the traditional method. It’s exciting.
