WASHINGTON, D.C.—The American Cancer Society Cancer Action Network (ACS CAN) has been provided nearly one million dollars in support from Amgen for a pilot program to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials. The project will integrate regional cancer clinical trial matching capability into existing electronic health record (EHR) systems and will utilize clinical trial navigators to help patients address logistical and financial challenges to enrolling in and completing clinical trials.
Research shows more than half of eligible patients who are asked to enroll in a cancer clinical trial agree to enroll, irrespective of race or ethnicity, but many eligible patients are neither identified as eligible nor asked to participate. Surveys have shown that providers often don’t have the time or infrastructure to easily match a patient to a trial, a barrier that this project intends to overcome.
“Clearly we’re excited by the opportunity this funding provides. Low trial participation rates have long been identified as a challenge, and our research shows that far and away the biggest barrier is a lack of opportunity. If we can make this as easy as a couple of clicks within the medical record, we could go a long way toward changing the model of trial participation,” said Mark Fleury policy principal for ACS CAN. “Today, the only patients who are screened for trial eligibility are those at research institutions, and even there they are only being reviewed for trials at that individual site. This functionality makes it possible to easily screen patients at smaller, community sites where research may not otherwise be occurring, and it broadens the search across an entire region. Creating a simple, widely used trial screening process and helping navigate patients to identified trials could prove a strong template for how to boost enrollment and diversity of clinical trials.”
“Unfortunately, people of color who are diagnosed with cancer often have the lowest survival rates, yet minorities have historically been underrepresented in clinical trials,” said Darryl Sleep, M.D., senior vice president, Medical and chief medical officer at Amgen. “Sponsorship of this new pilot program by the American Cancer Society Cancer Action Network is just one way that Amgen is fulfilling its commitment to increase more equitable representation in clinical trials in hopes that new, innovative investigational cancer treatments reach all patients.”
The project concept originated from a 2018 report identifying common enrollment barriers for cancer clinical trials and an associated set of consensus recommendations. The project has been developed through input from multiple stakeholders and is being implemented through a collaboration with the CodeX, a member-driven HL7 FHIR Accelerator leveraging interoperability standards towards better and innovative patient care and research.
With funding secured, ACS CAN and the partners within CodeX are finalizing the protocol for the pilot study, which will be implemented at multiple sites and is expected to screen between 400 and 600 patients for trial eligibility over the course of two years. If the program ultimately proves successful, institutions could use a free, open-source application to integrate matching services at any of their locations.