On October 15th, the Jumpstarting Brain Tumor Drug Development Coalition - including Accelerate Brain Cancer Cure, National Brain Tumor Society, The Musella Foundation for Brain Tumor Research & Information, and the Society for Neuro-Oncology - held the second of two clinical trial endpoints workshops this year. This Workshop focused on clinical outcomes assessments (COAs) – how we measure whether a drug is not only extending survival but also reducing the symptoms, signs, or increasing functionality of patients.
The workshop was a resounding success. Over 100 people attended representing about 14 pharmaceutical companies, approximately 19 senior FDA staff, key representatives of the National Cancer Institute, neuro-oncology community leaders and importantly – patients and caregivers.
Stakeholder groups worked together through four panel sessions led by Drs. Terri Armstrong (University of Texas Health Science Center & MD Anderson), Jaishri Blakeley (Johns Hopkins), Mark Gilbert (MD Anderson) and Patrick Wen (Dana-Farber).
A big take away from the workshop is how important the inclusion of patient-focused clinical outcomes assessments are going to be in the future for brain tumor drug approvals. The FDA said they want to see them be used more frequently and want them to more accurately help measure clinical benefit. "The workshop brought together the best minds in the field to talk through the complex issues surrounding patient-reported outcomes," said Max Wallace, CEO of Accelerate Brain Cancer Cure. "This was a great example of collaboration at the highest levels and we're proud to partner in this effort."
We thank all of the workshop participants for their time and dedication to the brain tumor community. Together we were able to develop an action a plan that has the potential to increase the inclusion of patient-focused endpoints in future brain tumor clinical trials.
A summary report of the workshop will be available soon.