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Real-World Evidence Assessed for Cancer Drug Trials

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Updated 15 Oct. 2019. Two medical technology companies are evaluating real-world evidence from patients to simulate randomized clinical trials for testing new cancer treatments. Financial and intellectual property aspects of the collaboration between Aetion Inc. in New York and McKesson Corp. in Irving, Texas were not disclosed.

Aetion is a health care analytics and technology company that collects data from patients’ electronic health records and other sources to apply big-data analytics for simulating outcomes from clinical trials. The company is in a project called RCT Duplicate — RCT stands for randomized clinical trials — with the Food and Drug Administration and Brigham and Women’s Hospital in Boston. RCT Duplicate is evaluating real-world evidence for simulating and supplementing clinical trial data.

As reported by Science & Enterprise in April 2019, RCT Duplicate started with assessing large data sets from three health insurance databases to find data comparable to 30 completed clinical trials. The project expanded to evaluate seven post-marketing clinical trials already underway. These studies, also known as phase 4 clinical trials, investigate adverse effects in therapies and medical devices already approved by FDA over longer time periods than in typical clinical trials.

In the new collaboration, Aetion is apply its technology to McKesson’s electronic oncology health record database to evaluate real-world medical outcomes that simulate data in clinical trials. The data are expected to cover breast, lung, and melanoma cancers. The companies will assess the ability of real-world evidence to provide data for cases where recruiting participants in trials is impractical, for example, control groups of ill participants given a placebo instead of the experimental treatment. Other examples are testing new uses for treatments or in new target populations, fulfilling post-marketing safety requirements, and evaluating economic impacts.

Aetion and McKesson plan to share their findings first with the RCT Duplicate project. The companies also take part in a real-world evidence or RWE project hosted by Friends of Cancer Research, evaluating treatments for advanced non-small cell lung cancer. This project already demonstrated the feasibility of tapping into different data sets to extract consistent findings on real world outcomes, and is now describing demographic and clinical characteristics of patients with non-small cell lung cancer, as well as evaluating real-world clinical trial objectives or endpoints for front-line immunotherapies.

“Combining our real-world evidence platform with McKesson’s cancer data accelerates time to insight when conducting oncology analyses,” says Carolyn Magill, CEO of Aetion in a joint statement. “This collaboration enables us to provide researchers with the tools to advance cancer research with greater efficiency and precision.”

“Our goal is to get therapies to market faster to help life sciences companies and drive better health for patients,” adds Derek Rago, vice-president and general manager at McKesson. “Based on the ability of observational studies to gain insight into treatment patterns and outcomes in clinical practice, the FDA is supportive of the expanded use of RWE to inform a variety of regulatory decisions.”

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