New Data Supporting Use of Real-World Evidence Presented with Six Data Partners as well as FDA
July 10, 2018 – Washington, DC – Today, Friends of Cancer Research (Friends) released the results of a unique pilot project at its event, The Future Use of Real-World Evidence. Data was compiled from six data partners regarding patients receiving approved immune activating drugs. The findings from the data support the use of real-world evidence (RWE) for assessing the long-term impact of a treatment.
“New sources of data may require new methods of analysis for real-world evidence to be used to its full potential,” said Friends’ President & CEO, Jeff Allen. “To explore how endpoints derived from healthcare data relate to more traditional measures, Friends convened a group of partners to design a pre-competitive study to compare how different data sets can be used to evaluate outcomes in lung cancer.”
The analysis undertaken by the working group found the following key findings:
- There is notable correlation between several real-world endpoints and overall survival (OS), indicating that real-world endpoints have the potential for evaluating treatment benefit.
- The range of OS observed in clinical trials used to approve checkpoint inhibitors is highly similar to the range observed in real-world populations, demonstrating that in this case the results from the clinical trial are generalizable to the broader population.
- Treatment effects assessed by real-world endpoints were consistent across a variety of demographic factors, such as age and sex, although differences were observed across lines of therapy and stage of disease.
The U.S. Food and Drug Administration (FDA) also presented new data at the meeting. Their findings show that based on aggregated clinical trial data, progression free survival is highly correlated with TTD.
Clinical trials provide the high quality data necessary to support claims of safety and efficacy for FDA drug approval. However, clinical trials do not necessarily reflect the breadth of data that can be collected by evaluating products in a more diverse real-world setting. While there has been a lot of interest in RWE, parameters and conditions of use have not been well defined and traditional clinical endpoints may be difficult to obtain and evaluate from real-world data making new metrics a potential necessity.
Data partners participating in this pilot project include: COTA, Flatiron, IQVIA™, Kaiser Permanente/CRN, Mayo Clinic/OptumLabs®, and PCORnet/University of Iowa
About Friends of Cancer Research
Friends of Cancer Research (Friends) drives collaboration among partners from every healthcare sector to power advances in science, policy and regulation that speed lifesaving treatments to patients. For more information, please visit www.focr.org.