- Ellen Sigal and Marlene Malek establish Friends of Cancer Research, (Friends), to mark the 25th anniversary of the National Cancer Act. Friends sets out to bring together researchers, leaders of federal health agencies, industry, and elected officials, through town hall events across the country to discuss ways cancer treatment should improve.
- Friends begins to hold town halls across the country on the importance of cancer research with federal support.
- March to Conquer Cancer brings 80,000 people to the National Mall.
- Friends plays important role leading to the doubling of the NIH budget.
- Friends begins to pivot focus to the U.S. Food and Drug Administration (FDA), which historically had not been the focus of any cancer research organization.
- Friends leads the entire research community to advocate for the creation of a new office at the FDA dedicated entirely to oncology products, the FDA Oncology Office.
- Stemming from the development of the Oncology Office at FDA, cancer research shifts toward patient-centered outcomes so government, advocates, and patients could work together.
- As part of the nationwide effort to pass and establish the Affordable Care Act, Friends pioneers comparative effectiveness research and works with bipartisan leadership establishing the Patient-Centered Outcomes Research Institute or PCORI.
- Friends and the Engelberg Center for Healthcare Reform at the Brookings Institution co-host the First Annual Conference on Clinical Cancer Research to discuss potential approaches to speed the FDA approval process for drugs that show large treatment effects early in development while still ensuring drug safety and efficacy.
- Friends took ‘Breakthrough’ from concept, to scientific whitepaper, to bipartisan legislative solution, to a tool in full use by FDA to expedite the approval of multiple drugs in 13 months.
- Lung-MAP, the lung cancer master protocol, is first proposed at the 2012 Annual Conference on Clinical Cancer Research with the final trial design announced at the 2013 conference. The Lung-MAP trial launches in 2014 at more than 400 sites across the country.
- The Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) tool is launched at the annual Conference on Clinical Cancer Research.
- Ellen Sigal appointed to the National Cancer Institute’s Blue Ribbon Panel, advising the National Cancer Advisory Board on Vice President Joe Biden’s Cancer Moonshot Initiative.
- Friends holds a Congressional briefing to discuss establishing the FDA Oncology Center of Excellence.
- As a result of months of work led by Friends and other advocacy organizations, President Barack Obama signs the 21st Century Cures Act into law, including $1.8 billion for the Cancer Moonshot, and formally establishing the Oncology Center of Excellence at FDA.
- American Society of Clinical Oncology (ASCO) and Friends begin a joint project to develop and advance specific strategies to change the exclusionary nature of clinical trial eligibility criteria.
- The Annual Alexandria Summit and Friends Blueprint for Breakthrough Forum focuses on the potential utility of Real-World Evidence (RWE) in clinical trials.
- A panel of experts explore the issue of outdated product labels and release a whitepaper detailing a framework for updating product labels at the Friends Annual Meeting.
- ASCO-Friends joint research statement and four supporting manuscripts about eligibility criteria are published in the Journal of Clinical Oncology.
- Exploring the use of Circulating Tumor DNA (ctDNA) to monitor treatment response (ctMoniTR) Whitepaper presented at the Friends Annual Meeting.
- Friends convenes a multi-stakeholder group to discuss the Pilot Project 1.0: Operationalizing and Validating Real-World Evidence.
- Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) introduce the MODERN Labeling Act.
- Friends present in silico assessment of variation in TMB quantification across diagnostic platforms: Phase 1 of the Friends Harmonization Project at the SITC Annual Meeting.
- ASCO and Friends submit recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials to the FDA.
- Pilot Project 2.0 of Real-World Evidence project is presented at the Friends and Alexandria Real Estate Equities, Inc. Annual Blueprint for Breakthrough Forum.
- Senate health committee Chairman Lamar Alexander (R-Tenn.) and Ranking Member Patty Murray (D-Wash.) introduced S.1895, the Lower Health Care Costs Act of 2019, which addresses the public health issue of outdated labels identified by Friends work.
- Friends presents the results of Step 1 of the CtMoniTR Project convening clinical and academic leaders, government, industry, and leading advocates to align on a methodology to analyze ctDNA.
- Friends presents RWE whitepaper informed by RWE Pilot Projects.
- Reagan-Udall Foundation for the FDA, in collaboration with Friends, launches the COVID-19 Evidence Accelerator initiative.
- Phase 2B of the Friends TMB Harmonization Project, alignment of TMB measured on clinical samples, is presented at the AACR Annual Meeting.
- Phase II of the Friends TMB Harmonization Project, TMB standardization by alignment to reference standards, is presented at the ASCO Annual Meeting.