Solutions To The Challenges Of Oncology Trials

This significant Phase III trial, one of the largest global studies in head and neck cancer with over 900 participants, was a Rescue study that faced considerable challenges. These hurdles included enrollment delays, operational management complexities, and an intricate study design. The Investigational Medicinal Product (IMP), a neoadjuvant immunotherapy administered three weeks before surgery, works by modulating both the tumor and the patient's anti-tumor immune response. Successful execution required close coordination among various hospital departments – surgery, oncology, radiotherapy, radiology, and pathology. Further complicating the study was the need to harmonize diverse standard of care treatments with the protocol across numerous sites in North America, Europe, and Asia, as well as the involvement of multiple study vendors.