Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, has announced a strategic partnership with MMS, a global data-focused clinical research organization, to tackle one of oncology's most persistent challenges: interpreting interim overall survival (OS) data in clinical trials.
The collaboration addresses a critical gap in cancer drug development where researchers struggle to assess long-term treatment benefit when OS data remain immature. While many oncology studies rely on endpoints such as progression-free survival (PFS) and objective response rate (ORR) as initial indicators of treatment efficacy, evaluating OS data at interim points can complicate the assessment of long-term benefit or harm.
Addressing Complex Trial Design Challenges
The initiative builds on discussions from the Friends 2024 Annual Meeting and focuses on developing practical frameworks and simulation tools to support decision-making around immature OS data. The effort aims to support confidence in accelerated approval processes from the U.S. Food and Drug Administration while ensuring timely patient access to innovative therapies.
"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 convened a multistakeholder consortium including experts from government, academia, industry, and patient advocacy to guide this rigorous, consensus-driven effort. The consortium will evaluate modeling strategies and define evidence-based approaches to address complexities such as treatment crossover effects and delayed treatment benefits.
Advanced Simulation Platform Drives Innovation
MMS was selected for this project based on its simulation platform, KerusCloud®, and its deep bench of regulatory and statistical experts. The platform enables realistic modeling of oncology endpoints and allows stakeholders to explore different scenarios and decision thresholds, providing clear insights into potential risks and benefits associated with acting on immature data.
"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, CEO at MMS. "Having supported several key oncology approvals, we are uniquely positioned to help model the right questions and deliver practical frameworks that will shape future regulatory guidance and support better decision-making across the field."
Aiden Flynn, PhD, Senior VP Strategic Statistical Consulting at MMS, emphasized the practical applications: "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."
Delivering Practical Solutions for Industry
The collaboration will produce comprehensive resources including a simulation framework and practical recommendations to support the design and evaluation of oncology trials incorporating interim OS evaluations. These outputs are designed to inform both internal trial decisions and broader regulatory considerations.
The initiative represents a significant step toward addressing longstanding challenges in oncology drug development, where the need for timely patient access must be balanced against the requirement for robust evidence of treatment benefit. By developing data-driven policy solutions, the partnership aims to optimize acceleration in cancer therapy development while maintaining scientific rigor.
