Following on the success of the prior year’s joint meeting with the NCI, we partnered with the National Brain Tumor Society, the Musella Foundation for Brain Tumor Research & Information and the Society for Neuro-Oncology to form the Jumpstarting Brain Tumor Drug Development Coalition. To date, this group has hosted a pair of workshop meetings. The meetings recognized that one of the barriers to effective brain tumor treatment is the inability to know if a tumor is responding to treatment as measured by imaging. Another barrier is the lack of treatments that also alleviate or eliminate symptoms of brain tumors based on alternative endpoints.
The goal of the first workshop was to present the state of the field in imaging measurement of glioma progression and in response to drugs, to discuss emerging techniques and technologies in imaging and to discuss clinical trials designs involving various endpoints and drugs in newly diagnosed and recurrent glioma populations. Both the FDA and the NCI assisted in the planning of the meeting. At the conclusion of the meeting participants developed an action plan to advance the field.
The second endpoints workshop focused on the development and inclusion in clinical trials of alternative clinical endpoints such as quality of life, including those measured by patient-reported outcomes and objectively tested neuro-cognitive measures. After each of the two large group meetings there were subgroup meetings to further explore and refine the thoughts and recommendations generated. These efforts resulted in a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials. It was recommended that this become the new standardized approach to acquisition of imaging data in multi-center clinical trials in order to help better assess if a new treatment is effective against a brain tumor. This protocol was published in the journal Neuro-Oncology and is now in being adopted around the world.