We first told you about our Clinical Trial Endpoints Initiative back in late June of 2013.
We then let the Chair of the Initiative’s Steering Committee, Dr. Patrick Wen of Dana-Farber Cancer Institute, explain the promise of this effort further in a video interview we posted back in December.
Now, we’d like to introduce you to the Jumpstarting Brain Tumor Drug Development Coalition, which is a united community effort to advance brain tumor clinical trial endpoints – a term meaning the “benefits” of a drug to a patient. The Coalition will be sponsoring the two upcoming workshops that are the cornerstone of the Clinical Trial Endpoints Initiative. In addition to the National Brain Tumor Society, the Coalition includes:
To refresh, by bringing together all of the parties (clinicians, researchers, biopharma, patient advocates, philanthropic organizations and the FDA) that are critical to brain tumor drug development, the Coalition aims to achieve the most favorable clinical trials process possible for determining if new treatments are both safe and effective for brain tumor patients.
With a more clear-cut pathway through the regulatory approvals process, further biotech and pharmaceutical investment into brain tumor drug development will be incentivized and early stage treatments showing promise will stand a greater chance of accelerated approval thereby opening a new pipeline for treatments that can help patients.
Our first workshop, on imaging-related endpoints, is coming up on January 30. The second, on endpoints related to patient-reported outcomes, will convene in May. We look forward to continuing the dialog with the community as we progress.