Clinical Trial Development in TP53-Mutated Locally Advanced and Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.

TP53 mutation is the most frequent genetic event in head and neck squamous cell carcinoma (HNSCC), found in more than 80% of patients with human papillomavirus-negative disease. As mutations in the TP53 gene are associated with worse outcomes in HNSCC, novel therapeutic approaches are needed for patients with TP53-mutated tumors. The National Cancer Institute sponsored a Clinical Trials Planning Meeting to address the issues of identifying and developing clinical trials for patients with TP53 mutations. Subcommittees, or breakout groups, were tasked with developing clinical studies in both the locally advanced and recurrent and/or metastatic (R/M) disease settings as well as considering signal-seeking trial designs. A fourth breakout group was focused on identifying and standardizing biomarker integration into trial design; this information was provided to the other breakout groups prior to the meeting to aid in study development. A total of 4 concepts were prioritized to move forward for further development and implementation. This article summarizes the proceedings of the Clinical Trials Planning Meeting with the goal of developing clinical trials for patients with TP53-mutant HNSCC that can be conducted within the National Clinical Trials Network.

Improving Patient Advocacy in NCI Scientific Steering Committees and Task Forces.

This commentary discusses improving research advocacy as part of National Cancer Institute (NCI) clinical trial activities in scientific steering committees and task forces between 2016 and 2020. Before 2016, the focus of patient advocate input on clinical trial concept evaluation was assessing accrual feasibility. By leveraging informal benchmarking and an outside-in perspective, the NCI patient advocate steering committee, comprised of NCI scientific steering committee and task force advocates, has recalibrated research advocacy within and across its clinical trial concepts. Additionally, by focusing on research advocacy fundamentals, the NCI patient advocate steering committee clarified the scope of the research advocate roles, focused its mission, defined and developed competencies, measured engagement, and created collateral and processes that support better interactions and greater value generation. Continuous improvement in the collateral and the underlying approaches, along with calibrating their application and monitoring results, will be necessary to keep pace with the science and further enhance the value of cancer clinical trial research advocacy. The road ahead should build on these fundamentals and include increased emphasis on diversity, equity, and inclusion in clinical trial and research advocacy participants and the supporting infrastructure.

National Collaborative to Improve Oncology Practice: The National Cancer Institute Community Cancer Centers Program Quality Oncology Practice Initiative Experience.

Collaboration between QOPI and the NCCCP sites represents an evolution in the QOPI process, in which QOPI provides a metric for measuring quality and serves as a springboard for comprehensive quality improvement across independent but mutually committed practices.