A collaboration of 10 healthcare research organizations has demonstrated that real-world endpoints can be used to describe patient outcomes that are analogous to results generated through conventional endpoints in clinical trials.
The effort, drawn in part from data contributed by health IT companies with oncology portfolios, is the most recent phase of a three-year pilot study led by Friends of Cancer Research. At a virtual conference Sept. 21, Friends announced the conclusions of this phase of the project.
The project focuses on outcomes for real-world patients with non-small cell lung cancer who received immune checkpoint inhibitors. In this phase of the project, researchers assessed the utility and validity of real-world endpoints across three NSCLC cohorts—patients who received platinum doublet chemotherapy, PD-(L)1 monotherapy, and PD-(L)1 + doublet chemotherapy. These real-world patient outcomes were then “benchmarked” against clinical trial results.
“We call this the results of an analysis using Pilot 2.0 data, with 10 of our data partners, who have performed these analyses for today’s discussion,”
Jeff Allen, president and CEO of Friends, said in the conference.
The results of the analysis show that the magnitude of benefit obtained from immuno-oncology treatment regimens in the real world—i.e. measured via real-world overall survival and time to treatment discontinuation—is directionally similar to outcomes in a conventional clinical trial.
The groups taking part in this phase of Pilot 2.0 are: ASCO CancerLinQ/ConcertAI, COTA, Flatiron Health, IQVIA, Kaiser Permanente/Cancer Research Network, Mayo Clinic & OptumLabs, McKesson, SEER-Medicare Linked Database, Syapse, and Tempus. FDA and NCI served …