Friends of Cancer Research

Friends of Cancer Research Friends of Cancer Research powers advances in science and policy that speed life-saving treatments to patients.

Mission
Friends of Cancer Research powers advances in science and policy that speed life-saving treatments to patients. About Us
Friends of Cancer Research 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 po

licy. How we work at Friends of Cancer Research:
We identify problems standing in the way of the best science reaching patients. We generate the evidence necessary to understand a problem. We create policy solutions to address and overcome that problem.

As multi-regional clinical trials play an increasingly central role in oncology drug development, sponsors and researche...
04/17/2026

As multi-regional clinical trials play an increasingly central role in oncology drug development, sponsors and researchers face growing challenges, from variability in site readiness and startup timelines to differences in standards of care and enrollment patterns across regions. These complexities extend beyond operations, directly affecting the interpretability of trial data and, ultimately, regulatory decision-making.

Join Friends of Cancer Research at the American Association for Cancer Research (AACR) 2026 Annual Meeting session, “Strengthening the Oncology Trial Ecosystem Through Operational and Regulatory Innovation,” on Monday, April 20 at 10:15AM PST. Mark Stewart, Lola Fashoyin-Aje, Jay Lebsack, Terrell Baptiste, Bea Lavery, Funda Meric-Bernstam, and Judith Fitzgerald will discuss practical and policy-driven approaches to improve trial efficiency while ensuring the data we generate are meaningful for patients in the U.S. and around the world. https://www.abstractsonline.com/pp8/ #!/21436/session/15.

We hope to see you in San Diego! Stop by and join the conversation.

Our recent meeting, Application of External Control Arms in Oncology Drug Development, brought together experts from ind...
04/15/2026

Our recent meeting, Application of External Control Arms in Oncology Drug Development, brought together experts from industry, academia, regulatory agencies, and patient advocacy organizations to explore how external control arms (ECAs), built from existing clinical trial and real-world data, can strengthen oncology drug development, support regulatory decision-making, and expand patient access to promising treatments.

Several key themes emerged across three sessions:
▪️ECAs may be particularly valuable in settings, such as rare diseases or small patient populations, where traditional trials are challenging.
▪️There are critical limitations in data completeness and the ability to assess comparability between real-world data and trial populations
▪️Variability across data sources and understanding what lies behind each dataset is essential to interpreting results.
▪️ECAs could support more pragmatic, patient-centered trials that better reflect real-world settings, but there remain operational and methodological challenges.
▪️Enabling more robust comparisons is key to better understanding how data and methodological choices shape ECA performance.

Read the full recap on our blog (https://bit.ly/4sDahSV) and watch the full meeting on YouTube (https://bit.ly/4c9vDRX).

04/14/2026

Friends of Cancer Research co-founder Ellen Sigal lost her only sister to breast cancer. The experience of losing her sister—and having to tell her four-year-old niece that her mother was gone—has never left her.

In 1996, Ellen founded Friends of Cancer Research because she believed patients should not feel powerless in the face of science and policy. For the past 30 years, she has worked alongside patients, scientists, regulators, and policymakers to alleviate delays, uncertainty, and uneven access to innovation.

Together, we can accelerate access to promising therapies, strengthen regulatory decision-making, and ensure that scientific progress translates into real benefits for patients. Celebrate 30 years of Friends of Cancer Research with a donation today: https://bit.ly/4uzTYZz.

We are heading to the American Association for Cancer Research (AACR) Annual Meeting!This year's theme — advancing cance...
04/13/2026

We are heading to the American Association for Cancer Research (AACR) Annual Meeting!

This year's theme — advancing cancer science to save lives globally — reflects continuous innovation in cancer research, from AI-driven discovery and early detection to cell therapies, radiopharmaceuticals, and evolving regulatory frameworks.

We will also join the session, “Strengthening the Oncology Trial Ecosystem Through Operational and Regulatory Innovation” on Monday, April 20 at 10:15 AM PT, presenting new data on trial site activation timelines. The panel discussion will explore how operational and regulatory innovation can strengthen the oncology trial ecosystem: https://www.abstractsonline.com/pp8/ #!/21436/session/15.

Come say hi to Ellen Sigal, Jeff Allen, Mark Stewart, Hillary Andrews, Bernat Navarro, and Elena Levi-D'Ancona. See you there.

Patient Advocates! Join us for our free webinar, “Advocates Webinar: Application of External Control Arms in Oncology Dr...
04/10/2026

Patient Advocates! Join us for our free webinar, “Advocates Webinar: Application of External Control Arms in Oncology Drug Development,” on Thursday, April 23, 2026, at 1pm ET.

External control arms (ECAs) use data from prior clinical trials or real-world data sources to generate comparative evidence when traditional randomized trials are not feasible, such as in rare cancers or small patient populations. This webinar will explore what reliable ECAs mean for patients including how they can support stronger evidence, better-informed regulatory decisions, and faster access to promising therapies.

This session builds on discussions from our April 7 public meeting, now available on-demand on our YouTube channel: https://bit.ly/4c9vDRX. We encourage advocates to submit questions to be answered by our panel of experts during the webinar.

Register today: https://bit.ly/4sY3fJU.

Register for our "Unlocking Next-Generation Therapies" public meeting on Wednesday, May 6 at 10:00AM ET! This meeting, h...
04/09/2026

Register for our "Unlocking Next-Generation Therapies" public meeting on Wednesday, May 6 at 10:00AM ET! This meeting, hosted in partnership with the Parker Institute for Cancer Immunotherapy, will include a networking breakfast and lunch, and panels will explore:

▪️IND readiness, patient population selection, and early-phase trial design considerations
▪️Improving predictability in early-phase clinical development without compromising safety
▪️Risk-based approaches to validation, comparability, and release specifications from IND through licensure
▪️The role of platform knowledge in supporting process evolution
▪️Longer-term policy and regulatory science opportunities, including structural alignment, pilot efforts, and legislative engagement to support sustained innovation and patient access

Register today to join us in person in Washington, DC or virtually: https://bit.ly/4sZadyf.

Thank you to everyone who attended our “Application of External Control Arms in Oncology Drug Development” meeting. Our ...
04/08/2026

Thank you to everyone who attended our “Application of External Control Arms in Oncology Drug Development” meeting. Our speakers presented new findings from the External Control Arm (ECA) Pilot Project, explored how ECAs can be integrated into oncology drug development, and examined the policy landscape surrounding their use. We hope you enjoyed the discussions and we look forward to seeing you at our next meeting.

◾ You can watch the meeting on-demand on our YouTube channel: https://bit.ly/4c9vDRX.
◾ Visit our events page to register for future public meetings: https://bit.ly/4oSeHUI.

04/06/2026

Last chance to register! Join us tomorrow in Washington, DC or virtually for our "Application of External Control Arms in Oncology Drug Development" meeting. This free event will explore how external control arms (ECAs) can enhance oncology drug development, support regulatory decision-making, and help expand patient access to promising treatments.

"Methodological and Data Insights from the ECA Pilot Project" will include a presentation of preliminary findings from our ECA Pilot Project by Bernat Navarro-Serer, PhD, Friends of Cancer Research Senior Policy Analyst. Panelists will discuss the methodological and operational lessons that emerged from the ECA Pilot Project, establishing a shared foundation for discussions on drug development applications and policy considerations.
▪️Elizabeth Garrett-Mayer, American Society of Clinical Oncology
▪️Ruthie Davi, Medidata, a Dassault Systèmes company
▪️Janet Espirito, Ontada
▪️Brad Karalius, AstraZeneca
▪️Cassadie Moravek, Pancreatic Cancer Action Network
▪️Jennifer R. Rider, ConcertAI
▪️C. K. Wang, (COTA) Verana Health

"Translating Evidence to Practice: Integrating ECAs into Oncology Drug Development" will apply lessons learned from the ECA Pilot Project to explore how the incorporation of ECAs into clinical trials enhances efficiency, interpretability, and patient-centricity.
▪️Ash*ta Batavia, J&J Innovative Medicine
▪️Pete Ansell, AbbVie
▪️Jaclyn Bosco, IQVIA
▪️Marie Bradley, FDA
▪️Neal Meropol, Flatiron Health
▪️Jane Perlmutter, Patient Advocate

"Policy Perspectives and Regulatory Priorities for ECAs" will examine the policy landscape surrounding ECAs, discuss emerging regulatory considerations and stakeholder priorities, and identify opportunities to strengthen transparency and advance responsible, scalable use of ECAs in oncology.
▪️Clay Alspach, Leavitt Partners and ACRO
▪️Amy Comstock Rick, FDA
▪️Joe Franklin, Biotechnology Innovation Organization
▪️Mark Lee, N-Power Medicine
▪️Donna Rivera, Canal Row Advisors

Register, explore panel topics, and learn more about the panelists: https://bit.ly/3LUNS4r.

04/02/2026

Lung-MAP stands apart by matching patients to targeted therapies based on their specific biomarkers—delivering personalized treatment pathways that few trials offer. Each arm of the study provides immediate, protocol-driven access to agents targeting the molecular drivers of a patient's cancer, offering clinical responses that can be game-changing.

Prioritizing patient enrollment in Lung-MAP is critical. It's our most robust engine for generating the data needed to secure regulatory approval for these targeted therapies while offering patients with rare biomarkers—like MET exon 14 skipping or MET amplification—the best possible therapeutic options available today.

Watch Marcia Horn, President and CEO of ICAN, International Cancer Advocacy Network and chair of the MET Crusaders, discusses the importance of Lung-MAP and its three new trial arms. Visit lung-map.org to learn more.

Kelly Cuvar was diagnosed with a rare form of sarcoma in 1999. With only about 900 people affected per year, there was l...
04/01/2026

Kelly Cuvar was diagnosed with a rare form of sarcoma in 1999. With only about 900 people affected per year, there was little incentive for large-scale drug developers to invest in treatments for such a small patient population. Without the dedicated work of organizations like Friends of Cancer Research, she would not be here today.

Friends of Cancer Research powers advances in science and policy that speed life-saving treatments to patients living with cancer.

Your contribution to Friends of Cancer Research will directly support our mission of accelerating cutting-edge cancer care for patients. Please consider donating today to help move this vital research forward: https://bit.ly/4uzTYZz.

Join us in one week for our "Application of External Control Arms in Oncology Drug Development" meeting!On Tuesday, Apri...
03/31/2026

Join us in one week for our "Application of External Control Arms in Oncology Drug Development" meeting!

On Tuesday, April 7, 2026, we are bringing experts from federal regulatory agencies, academia, industry, and patient advocacy to advance best practices for the use of external control arms (ECAs) in generating rigorous, reliable evidence and to explore how these approaches can strengthen regulatory decision-making and expand patient access to promising treatments.

During the meeting, we will present new findings from our multi-stakeholder pilot project examining whether independently constructed ECAs can approximate a target trial control arm across heterogeneous external datasets, including real-world data and historical clinical trial data.
Ahead of the meeting, explore the ECA Project Pilot Overview and Preliminary Findings to learn more about the project.

Attend in person in Washington, DC or virtually. Register today: https://bit.ly/3LUNS4r.

Thank you to the ECA Pilot data partners: AbbVie, American Society of Clinical Oncology, ConcertAI, Flatiron Health, Guardian Research Network, iOMEDICO, IQVIA, Medidata, Ontada Pancreatic Cancer Action Network, Tempus AI, and Verana Health.

As cancer therapies improve and patients live longer, clinical trial design is evolving, particularly around endpoint se...
03/30/2026

As cancer therapies improve and patients live longer, clinical trial design is evolving, particularly around endpoint selection. While overall survival (OS) remains the gold standard for measuring treatment efficacy, the time required to observe OS outcomes can delay regulatory approval and patient access to promising therapies.

To address this, surrogate and early endpoints, including those used as the basis of the Accelerated Approval pathway, are increasingly being explored. Our 2025 Scientific Report's "Establishing Early Endpoints for Drug Development" section focuses on both generating evidence for these endpoints and advancing pathways for their regulatory use.

Through our research, including two studies in advanced non-small cell lung cancer (aNSCLC), we evaluated circulating tumor DNA (ctDNA) as a potential early endpoint. These studies showed that reductions in ctDNA are associated with improved OS, supporting its potential to provide earlier insights into treatment benefit. While further work is needed to define its role across disease settings and ensure consistent, reliable use in clinical trials, these studies provide foundational evidence for incorporating ctDNA measurement in future studies.

In a complementary initiative, we assessed the FDA's Biomarker Qualification Program (BQP). From the program’s inception in 2016 through July 1, 2025, the BQP had accepted 61 projects, but only 8 biomarkers had been fully qualified, none as surrogate endpoints. Our analysis called for a dedicated framework to support the development of novel response biomarkers.

Read our 2025 Scientific Report to learn about our work in advancing the development and regulatory acceptance of early endpoints to support more efficient oncology drug development, accelerate evidence generation, and speed patient access to safe and effective therapies: https://friendsofcancerresearch.org/wp-content/uploads/Friends-Scientific-Report-2025.pdf.

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20036

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Thursday 9am - 5pm
Friday 9am - 5pm
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(202) 944-6700

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