Real-World Evidence | Friends of Cancer Research

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Real-World Evidence

Operationalizing and Validating Real-World Evidence

Recent Updates: Friends of Cancer Research hosted a public meeting titled The Future Use of Real-World Evidence on this topic on July 10, 2018. The meeting whitepaper, Establishing a Framework to Evaluate Real-World Endpoints, is now officially released.


The Definition: Real-world evidence (RWE) is the clinical evidence derived from data on the uses and potential benefits and/or risks of a medical product outside of a traditional clinical trial. This type of data and evidence are being studied to gain an improved understanding as to how they can relate to more traditional clinical endpoints and the long-term benefits of a product.


The Problem: Clinical trials do not necessarily reflect the breadth of data that can be collected in a more diverse real-world setting. There has been a lot of interest in RWE; however, parameters of use and conditions of use have not been well defined. Traditional clinical endpoints may be difficult to obtain and evaluate from real world data. New metrics may be necessary.


The Solution: There needs to be a standard dataset curation process and validated framework so data collection can be operationalized. Friends of Cancer Research (Friends) will convene stakeholders to curate data to determine how endpoints generated from real world data correlate with overall survival and other key indicators of disease burden from prior clinical trials. The group will use this data to help inform the development of a validation framework. This project will help inform ongoing regulatory discussions on the use of RWE by proposing a standard approach for data collection, as well as provide vital information about the long-term value of a product including its safety and efficacy.

Operationalizing and Validating Real-World Evidence Project Overview

The Background:

Friends of Cancer Research hosted a series of meetings on RWE, which resulted in the following conclusions: