Stanford Researchers Named to Clinical Research Forum Top Ten List

Dr. James Zou, Assistant Professor of Biomedical Data Science, and Ruishan Liu, a Ph.D. student in Electrical Engineering, have received a Clinical Research Forum 2022 Top Ten Clinical Research Achievement Award in recognition of their study, “Evaluating eligibility criteria of oncology trials using real-world data and AI,” the results of which were published in Nature last year. Dr. Zou will present the research at the 2022 Translational Science Conference in Chicago, IL in April, and be honored at an awards gala during the conference.

The study focused on using data science and artificial intelligence (AI) to design clinical trials, with a specific focus on making clinical trials more inclusive.

“Trials frequently have pages and pages of eligibility criteria, which filters out a significant number of patients who would otherwise gain access to the latest treatments,” explained Dr. Zou. “These restrictions can also lead to the exclusion of female, minority, and older patients.”

Zou and Liu examined how more data-driven approaches to designing eligibility criteria could make it easier for patients to enroll in trials, while maintaining safety and effectiveness. Their research showed that some filters may not be necessary and are, in fact, overly restrictive.

“Trials frequently have pages and pages of eligibility criteria, which filters out a significant number of patients who would otherwise gain access to the latest treatments.”
                        – James Zou

The result was the creation of Trial Pathfinder, a computational framework that develops data-driven recommendations about eligibility criteria and what kinds of patients are suitable for a particular trial. Roche Genentech, whose team members partnered with Stanford on the project and co-authored the paper, is now piloting Trial Pathfinder internally to help design new cancer drug trials.

“We demonstrated that it is possible to relax trial enrollment criteria to include more participants without impacting drug efficacy or safety,” explained Liu. “It is a win for pharma companies as well as patients, because now they have a much larger pool of patients from which to recruit, making it easier and faster to run clinical trials.”

Dr. Ying Lu, Faculty Co-Director of the Spectrum CTSA BERD program, was a co-author and contributed to the analytic approach and manuscript.

____________________________________________________________

The Clinical Research Forum is a non-profit membership association of top clinical research experts and thought leaders from the nation’s leading academic health centers. The competition seeks to identify major advances in the biomedical field resulting from the nation’s investment in health and welfare. Award winners are selected based on the degree of innovation and novelty involved in the advancement of science; contribution to the understanding of human disease and/or physiology; and potential impact upon the diagnosis, prevention, and/or treatment of disease. To be eligible, research studies must have been published in a peer-reviewed journal in 2021 and must have been performed at a U.S. institution.