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Category: Research

Shaping the Future of Emerging Immunotherapies and Cell Therapies

On February 11, 2021, Friends of Cancer Research (Friends) hosted a virtual meeting highlighting and discussing the progress, challenges, and future of immunotherapies and cell therapies. Ellen Sigal, Chairperson & Founder of Friends, gave opening remarks and introduced keynote speaker Ned Sharpless, Director of the National Cancer Institute (NCI). Sharpless spoke about the progress made…

Modernizing Expedited Development Programs

Each year, the Friends of Cancer Research (Friends) Annual Meeting addresses critical issues in the development of new oncology drugs and features experts proposing unique approaches toward current challenges in drug development. On Day 1 of the 2020 Friends Annual Meeting, panelists will discuss FDA’s expedited development programs and discuss proposals outlined in the white…

An International Framework for Real-World Evidence – Day 2: Regulatory and Policy Needs for RWE

Day 2 of the Friends of Cancer Research (Friends) meeting on real-world evidence (RWE) turned the focus from Day 1  to the regulatory and policy implications of real-world evidence.  The hour-long meeting was comprised of two parts: a keynote conversation featuring Amy Abernethy, Deputy Commissioner of the FDA and a leader in the agency on…

An International Framework for Real-World Evidence – Day 1: RWE Pilot Project Results

September 21st was the first day of the Friends of Cancer Research (Friends) virtual meeting on real-world evidence (RWE). Day 1 covered findings from the RWE Pilot 2.0 Project, exploring the outcomes of patients with advanced non-small cell lung cancer (aNSCLC) treated with immunotherapy versus chemotherapy, as well as related RWE projects from partner institutions…

A Culmination of the Real-World Evidence Pilot Projects

This is the final post in the Real-World Evidence (RWE) blog series where we will discuss the Friends of Cancer Research (Friends) whitepaper titled: “Recommendations for Use of Real-world Evidence in Oncology: Lessons Learned from the Friends of Cancer Research Real-world Evidence Framework. ”   The whitepaper, informed by the pilot projects we reviewed in…

Using RWE Pilot 2.0 to Confirm Internal Consistency in Clinical Trials

This is the fourth installment in our Real-World Evidence (RWE) blog series where we highlight key findings and implications from the RWE pilot projects. You may view previous posts here, here, and here. In this post, we will review the Internal Consistency project, which investigated use of the RWE framework to select a clinical trial…

Expanded Applications to Validate the Real-World Evidence Framework

In our previous blog posts we discussed Pilot 1.0 and Pilot 2.0 of the Real-World Evidence (RWE) Project. The goal of the RWE pilots is to create better characterization for the role real-world endpoints could play in evaluating drug effectiveness. In this blog, we will review two collaborations that formed between Friends of Cancer Research…

Pilot Project 2.0: Surveying the Use of Real-World Endpoints

In the first post of the Real-World Evidence (RWE) blog series, we discussed Pilot Project 1.0 , and the collaborative effort to build consensus around the role of RWE in oncology. In this post, we will explore Pilot Project 2.0: Establishing the Utility of Real-World Endpoints, a key element about RWE that requires further investigation…

An Overview of Pilot Project 1.0 of the Real-World Evidence Project

This is the first of a five-part blog series on Real-World Evidence leading up to the September 21st RWE meeting . The series will highlight how Friends of Cancer Research (Friends) is working with various stakeholders to identify key elements about real-world evidence (RWE) that require further investigation for use in drug development and contribute to consensus…

ctMoniTR Step 1 Results: Do Changes in ctDNA reflect response to treatment?

Click HERE for the August 25th Q&A Recap   On Tuesday, August 11, 2020, Friends of Cancer Research (Friends) presented the results of Step 1 of the ctDNA for Monitoring Treatment Response (ctMoniTR) project. Step 1 involved convening clinical and academic leaders, government, industry, and leading advocates to align on a methodology to analyze ctDNA (circulating tumor…