Friends of Cancer Research and MMS Collaborate to Develop Decision Frameworks for Interim Overall Survival Data in Oncology Trials

MMS, a global, data-focused clinical research organization (CRO), announced today that it has been chosen by Friends of Cancer Research (Friends), a leading nonprofit dedicated to accelerating innovation in cancer research, to support the development of practical decision frameworks to inform the interpretation of interim overall survival (OS) data in oncology clinical trials.

The collaboration addresses a longstanding challenge in cancer drug development: how to assess long-term treatment benefit when OS data remain immature. In many oncology studies, developers use endpoints such as progression-free survival (PFS) and objective response rate (ORR) as an initial indicator of treatment efficacy. However, evaluating OS data at the same interim point can complicate the assessment of long-term benefit or harm. To provide clarity, Friends has convened a consortium of stakeholders to develop and evaluate different modeling scenarios, including crossover effects and delayed treatment benefits.

Friends selected MMS to lead simulation and modeling efforts for this project based on both its simulation platform, KerusCloud®, and its deep bench of regulatory and statistical experts. The MMS platform enables realistic modeling of oncology endpoints and allows stakeholders to explore different scenarios and decision thresholds, providing a clear view of the potential risks and benefits associated with acting on immature data in oncology clinical trials, and supporting more informed decisions earlier in the trial process.

“As timely access to innovative cancer therapies remains a key factor for patients, this initiative represents an important step toward optimal acceleration,” said Jeff Allen, PhD, President and CEO, Friends of Cancer Research. “At Friends, we work with key stakeholders to generate the evidence necessary to understand a problem, and develop data-driven policy solutions to address and overcome that problem; all while keeping the patients front of mind. We are excited to partner with MMS along with the consortium, who bring a combination of statistical depth, real-world understanding of oncology trial design, and powerful simulation tools to help tackle these challenges.”

Improving Oncology Clinical Trials with the Right Technology and the Right Stakeholders

“Friends of Cancer Research 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.”

“By combining our 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, Sr. VP Strategic Statistical Consulting at MMS.

The collaboration is expected to result in practical guidance and a simulation toolbox that can be shared broadly across the oncology community, helping stakeholders better anticipate the implications of interim OS data on regulatory decisions. By equipping researchers with a practical, scientifically robust toolkit, this program promotes a consistent and transparent approach to evaluating early survival signals, supports timely decision-making, and fosters continued innovation in cancer drug development.

About Friends of Cancer Research

Friends of Cancer Research (Friends) powers advances in science and policy that speed life-saving treatments to patients. Friends aims to accelerate cutting edge cancer care that both extends and improves quality of life for patients.  To accomplish this, we leverage groundbreaking collaborations, generate scientific evidence, and integrate patient input to shape public policy. For more information, please visit https://friendsofcancerresearch.org 

About MMS

MMS Holdings (MMS) is an award-winning, data-focused clinical research organization (CRO) that supports the pharmaceutical and biotech industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, a 19-year track record, AI technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner. With a global footprint across four continents, MMS maintains an industry-leading customer satisfaction rating. For more information, visit www.mmsholdings.com.