Friends of Cancer Research (Friends) launched the next phase of an initiative to improve how to interpret interim overall survival (OS) data in oncology clinical trials. Building on discussions during the Friends 2024 Annual Meeting, this new effort focuses on developing practical frameworks and simulation tools to support decision-making around immature OS data in an effort to support confidence in accelerated approval from the U.S. Food and Drug Administration.
Although OS remains a gold standard endpoint in oncology drug development, interim analyses can pose challenges due to limited maturity, treatment crossover, or delayed effects. These complexities hinder data interpretability, making it difficult to draw clear conclusions from interim survival analyses without careful planning. To address this, Friends has convened a multistakeholder consortium—including experts from government, academia, industry, and patient advocacy—to guide a rigorous, consensus-driven effort, evaluate modeling strategies, and define evidence-based approaches.
As part of the technical modeling work, Friends is partnering with MMS, a global clinical research organization with expertise in simulation and regulatory science. MMS will support this project using its KerusCloud platform to conduct simulations across a range of clinical trial scenarios.
“Timely access to innovative cancer therapies is critical for patients, and this initiative is an important step toward accelerating that progress,” said Jeff Allen, PhD, President and Chief Executive Officer of Friends. “We’re proud to partner with MMS and other experts who bring statistical expertise, real-world oncology trial experience, and advanced simulation tools to help address these challenges with data-driven solutions.”
“Friends has long been a catalyst for forward-thinking collaboration in oncology, and we are grateful they have trusted MMS to support this vital initiative,” said Uma Sharma, PhD, Chief Executive Officer at MMS.
“By combining regulatory insight with advanced simulation capabilities, we are helping develop practical tools and decision frameworks that give developers greater confidence to act on early data, and ultimately improve access for patients,” added Aiden Flynn, PhD, Sr. VP Strategic Statistical Consulting at MMS.
The collaboration will produce resources, including a simulation framework and practical recommendations, to support the design and evaluation of oncology trials incorporating interim OS evaluations. These outputs will inform internal trial decisions and broader regulatory considerations.
To learn more about this project, visit friendsofcancerresearch.org/interim-os and read the 2024 white paper Enhancing Study Designs and Interpretation of Interim Overall Survival Data in Oncology Trials.
