New findings led by researchers at the American Cancer Society and American Cancer Society Cancer Action Network (ACS CAN) show that regional trial eligibility screening holds the promise of substantially increasing the number of patients who are found eligible to enroll in cancer clinical trials. Three papers, published [October 19] in Cancer, examine barriers to better clinical trial matching and ways to address them, including using automated screening tools.
One paper, titled Feasibility of Institution-Agnostic, EHR-Integrated Regional Clinical Trial Matching, lays out a framework that would provide the foundation for development of an automated screening tool. Stakeholders (from both an ACS CAN summit and a provider survey, described in the two companion papers) recommended the creation of automated screening tools and processes that would be integrated into provider workflows, directly interfacing with site electronic health records, that would search for trial eligibility in a regional manner.
“We’ve laid the foundation for a new way of thinking about getting more patients enrolled on clinical trials by showing we can identify significantly more trials for patients by looking beyond a single institution, and that the process can rely on using a relatively basic set of data,” said Sharon P. Shriver, Ph.D., Project Manager for ACS CAN and lead author. “In the paper, the framework was tested with collaborators at the Simmons Comprehensive Cancer Center at UT Southwestern Medical Center and found to identify clinical trial matches for 91% more patients than through the traditional process of only screening patients for eligibility for onsite trials.”
The paper titled Consensus Recommendations for Improving the Cancer Clinical Trial Matching Environment, identifies policy and infrastructure solutions that could enable more effective and more frequent use of third-party site-agnostic matching. The results come from a summit held by ACS CAN to examine challenges and propose consensus recommendations to address those challenges.
“The first step to a patient enrolling in a clinical trial is determining that there is a matching trial for which they are eligible, yet that process is really ad hoc and uncoordinated,” said Mark Fleury, Ph.D., Policy Principal for ACS CAN and lead author. “In convening stakeholders in this system, we believed that we could improve coordination and performance for the betterment of patients, and the resulting recommendations are the roadmap to make that happen.”
A third paper, titled Provider Motivations and Barriers to Cancer Clinical Trial Screening, Referral, and Operations: Findings from a Survey, sought to gain insight into cancer clinical trial enrollment practices through a survey of health care providers such as physicians and nurses. The survey looked at both opening and recruiting for onsite trials and referring to offsite trials.
“We know that enrolling more patients in trials means either opening more trials or helping match patients to a wider array of trials at multiple institutions," said Fleury. “Very little was known about provider behavior and motivations related to these practices, and here we’ve shown that more onsite trials are not opened largely due to resource constraints, and that external trial referrals are rare because of a lack of an easy way for providers to find these trials.”
ACS CAN partnered with the MITRE Corporation on the project within the CodeX FHIR Accelerator and developed an open-source tool to facilitate regional clinical trial matching, based on the framework described and validated in this paper. The initiative is referred to as “Blue-button” functionality, to reflect a movement first started by the U.S. government to improve access to care by allowing patients and providers direct, convenient access to patient records. ACS CAN is currently conducting a clinical trial at two locations to test the Blue-button tool’s effectiveness in identifying matching trials for oncology patients.
“These papers are a great example of ACS CAN bringing the research community together to not simply make recommendations, but to also roll up our sleeves and take action on the those recommendations,” said Lisa Lacasse, president of ACS CAN. “Low enrollment in clinical trials has been a problem for decades, and it will only be through sustained, evidence-based efforts, like automated screening tools, that we’ll move the needle.”