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AdminSep 13, 20232 min read

Aetion to Assess the Potential for Greater Inclusivity in Randomized Controlled Trials within the Field of Oncology

NEW YORK, NY, September 13, 2023— Aetion®, the global leader in real-world evidence (RWE) technology and analytics, announced today it will explore how to make randomized control trials (RCTs) in oncology more inclusive and reflective of real-world patients. This work represents a fitting addition to Aetion’s portfolio of oncology-related initiatives, including the CARE Initiative—a first-of-its-kind cross-industry initiative that brings together healthcare leaders to facilitate multiple trial emulations using various data sources to understand where real-world evidence is appropriate and where it is not, beginning with a focus on oncology. Historically, RCTs enroll more restricted patient populations than those treated in the real world. Enrollees of these trials are often healthier and largely homogenous in their representation of race and ethnicity, age, sex, and sexual orientation. This can result in trials that under-represent those most affected by a particular disease or condition and limits the ability to make well-informed health care decisions. Efforts to promote health equity, particularly in the area of clinical trials, have been directly addressed by the creation of the Office of Minority Health and Health Equity (OMHHE) within the U.S. Centers for Disease Control and Prevention (CDC) and the National Institute of National Health and Health Disparities (NIMHD), a division of the National Institutes of Health (NIH). The increased institutional commitment to greater inclusivity in clinical trials marks a positive step toward the improvement of health care outcomes for real world populations. To conduct this research, Aetion will utilize its advanced real-world data analytics application, Aetion® Substantiate, to emulate an oncology RCT with less restrictive inclusion and exclusion criteria. This will help researchers evaluate how broadening the patient population of RCTs can impact oncology treatments' effectiveness and safety. “Aetion is confident in our ability to move the needle in oncology research, particularly as it relates to more inclusive RCTs,” remarked Nicolle Gatto, Chief Science Officer at Aetion. “We are eager to see how broadened clinical trial inclusion may drive additional downstream effects, including easier patient enrollment processes, shorter trial timelines, and an overall decrease in the costs associated with the research and development of cancer treatments and interventions.” With support from Arnold Ventures, this effort will kick off in Q3 and culminate in a results paper that will detail the project’s findings. To learn more about Aetion’s real-world oncology solutions, get in touch with our experts here About Aetion Aetion is a healthcare analytics company that delivers real-world evidence for the manufacturers, purchasers, and regulators of medical treatments and technologies. Aetion’s suite of real-world data analytics applications analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on safety, effectiveness, and value. Founded by Harvard Medical School faculty members with decades of experience in epidemiology and health outcomes research, Aetion informs healthcare's most critical decisions—what works best, for whom, and when—to guide product development, commercialization, and payment innovation. Learn more at and follow us at @aetioninc.