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Author: Visceral Dev Admin

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…

TMB Results: The Future Use of Complex Biomarkers

On Thursday, July 23, 2020, Friends of Cancer Research (Friends) hosted the second in a two-part virtual meeting series, TMB Results: The Future Use of Complex Biomarkers, that focused on the harmonization of tumor mutational burden (TMB). The event covered the results from the TMB Harmonization Project and how the project’s efforts will impact the future use of…

The Future Use of Complex Biomarkers

Friends of Cancer Research (Friends) convened its first virtual symposium on Tuesday, July 14, 2020. The symposium, The Future Use of Complex Biomarkers, convened renowned speakers from several health care sectors, who discussed the current role of biomarker testing in cancer drug discovery and treatment, and explored the future of complex biomarker development. The Tumor Mutational…

A Closer Look into Phase 1 of the TMB Harmonization Project

The overall goal of the Friends of Cancer Research (Friends) Tumor Mutational Burden (TMB) Harmonization Project  was to ensure consistency across values from different TMB tests for cancer treatment. This article provides information about Phase I of the TMB Harmonization Project and how Friends worked to address the issue of TMB standardization. On March 26, 2020, the paper “Establishing…