The Standard

Clinical Trial Matching...Room for Improvement 

Clinical trials are essential to the advancement of patient care. The outcomes of a trial directly enable the future development of new treatment options for patients. Participants also benefit during the trial – they are provided access to potential treatments that may not be otherwise available to them – sometimes improving their overall prognosis.

Trial sponsors (the party responsible for the clinical trial) make significant investments, including procurement of products and services supporting the clinical trial workflow. According to the Tufts Center for the Study of Drug Development (CSDD), the mean direct cost to conduct a clinical trial per day is approximately $40,000 for Phase II and Phase III trials, and delays to launching a product can cost $800,000 per day.

With a very high percentage of trials delayed due to enrollment, there is much work to do to ensure clinical trials are sustainable and new therapies reach patients faster. Efficiencies gained in clinical trial matching benefit patients and their caregivers, sponsors and service providers.

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For a patient to be matched with the right trial, that patient’s medical history is compared with multiple trials’ criteria.   In concept, this is a simple process, but more information is often needed than is available in the patient’s record (in Part 1 we tell the story of Dr. Smith’s inability to easily obtain her patient’s medication history from his previous health care provider.) If, after a first evaluation, a patient isn’t disqualified, they must often undergo additional screening by their care team or more involved procedures required by the protocol sponsor to fully determine eligibility.

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Introduction

  Questions to Address:

• How can we build interoperability into this process with HL7 Fast Healthcare Interoperability Resources (FHIR®) – automating trial matching by fitting patient data and clinical trial criteria together like puzzle pieces?  

• Two separate-but-related teams within one of the world’s leading health data standards organizations are independently addressing aspects of this complicated puzzle.  Through more standardized patient medical records and machine-readable, digital clinical trial protocols, we can make progress toward a future state where trial matching is more accurate and seamless. You can be part of the journey!  

Thanks to the dedicated efforts of Gravity Project’s community members, volunteers, and staff, we made significant progress in advancing standards for Social Determinants of Health (SDOH) in 2024 that will shape the future of health data sharing.

Key Achievements

Gravity focuses on developing consensus-based standards that enhance data interoperability for SDOH. Our terminology, technical, and implementation workstreams all made notable progress in 2024 that we can leverage this year.  We provided valuable resources and guidance to help implementers adopt Gravity terminology effectively.

One of our standout initiatives was a six-week discovery project in February 2024, where over 20 cross-sector stakeholders collaborated to explore social care payment and reporting standards. This effort not only resulted in a comprehensive report but also fostered a deeper understanding of the landscape surrounding social care.

Join the Vulcan FHIR® Accelerator on March 26 as we kick off a monthly forum inviting open dialogue on the development of a HL7 Fast Healthcare Interoperability Resources (FHIR®) implementation guide (IG) for the exchange of a digital clinical trial protocol. Input across the broader HL7 community will help ensure a more robust and widely applicable IG.

About

The Utilizing the Digital Protocol (UDP) project focuses on developing a FHIR IG for exchange of protocols aligned to ICH M11 (Clinical electronic Structured Harmonized Protocols). UDP is an umbrella project to accelerate exchange of ICH M11 compliant protocols through collaboration and integration of work products across Vulcan, CDISC and TransCelerate.     

Vulcan’s UDP team will:

• Provide regular project updates, offering a touchpoint for stakeholders who want to stay informed.
• Create a platform for discussion, allowing community members to raise questions, share insights, and engage more directly.

HL7 International is pleased to announce the appointment of three distinguished members to its 2025 Board of Directors.

These new appointees bring a wealth of industry leadership and expertise across data standards, artificial intelligence and clinical innovation, and will serve a two-year term:

• Christopher Longhurst, M.D., M.S., FACMI, chief clinical and innovation officer, University of California, San Diego (UCSD)
  Longhurst is a nationally recognized leader in clinical informatics and digital health innovation. As the chief clinical and innovation officer at UCSD, Dr. Longhurst oversees a broad portfolio, including the Offices of the Chief Medical Officer, Quality and Patient Safety, Care Management, Information Services, and the Jacobs Center for Health Innovation, where he leads AI initiatives for personalized medicine and health equity. His leadership in developing cutting-edge health IT aligns with HL7’s mission to empower global health interoperability.
  
  
• Genevieve Melton-Meaux, M.D., Ph.D., FACMI, director, Center for Learning Health System Sciences, University of Minnesota
  Melton-Meaux is an accomplished leader in clinical informatics and AI implementation. With extensive research on learning health systems and digital transformation, she has pioneered strategies that optimize health IT and promote evidence-based care. The current chair of the American Medical Informatics Association (AMIA), her global recognition in AI-driven healthcare innovation underscores HL7’s dedication to advancing intelligent, interoperable solutions.
  

In its SDOH Playbook, “US Playbook to Address the Social Determinants of Health,” the White House explained that supporting flexible funding to address social needs, such as those offered through health-related social needs (HRSN) reimbursement programs, improves health outcomes: “Increasing funding flexibility and offering technical assistance that empowers organizations to utilize funding from a variety of sources will better equip them to address unmet social needs.”

The success of these reimbursement programs requires the existence of exchange and data standards that serve the interests of all stakeholders. Payers and community-based organization (CBOs) currently experience complexities and pain points that have presented challenges and made it difficult to meet the HRSN reimbursement programs’ full potential exist as these benefits roll out today.

As momentum has grown among states and payers for the reallocation of healthcare funds to address HRSNs, Gravity Project decided to undertake a discovery effort to understand and define the existing landscape for CBO reimbursement and identify the components of the CBO reimbursement process and where national standards play a role. 

"Unite Us is proud to work with the Gravity Project. Together, we are making it easier for community-based organizations to participate in Medicaid reimbursement programs, expanding the availability of these benefits to more individuals seeking care,” Emily Anders, director of payments strategy for Unite Us, said.

Health Level Seven International (HL7^®), the leading global standards-development organization dedicated to improving how healthcare information is shared, is excited to announce it has assumed stewardship of the open source FHIR^® Shorthand (FSH) tools from MITRE. This strategic transition will ensure the long-term sustainability and growth of these essential tools, which simplify and speed up the creation of HL7 Fast Healthcare Interoperability Resources (FHIR^®) implementation guides that define how healthcare data should be structured and shared between systems to ensure smooth and accurate data exchange.

HL7 FHIR Shorthand (FSH) is a streamlined, text-based tool that enables healthcare IT stakeholders to create implementation guides, or "blueprints," for sharing critical health information such as patient records, lab results, treatments across different systems, and much more. Developed by MITRE in 2020, the FSH standard has quickly become an essential tool in hundreds of healthcare projects worldwide, helping to simplify the process of developing systems that support better coordination and improved patient outcomes.

The Vulcan FHIR® Accelerator, in coordination with the US Assistant Secretary for Technology Policy/ Office of the National Coordinator (ASTP/ONC) and the Food and Drug Administration (FDA), invites you to an informational webinar for the Vulcan Interoperability Bridge (VIB) event.

The VIB event aims to accelerate the adoption of healthcare data standards for research – underscoring the value of using HL7 Fast Healthcare Interoperability Resources (FHIR®) to solve existing challenges and explore novel opportunities in research data interoperability.

The August 21 webinar is designed to share information on how we will convene clinical research sponsors, including pharmaceutical companies and academic medical centers, EHR providers, clinical research sites, and technology solutions providers to work together to demonstrate how clinical care and research interoperability is achievable utilizing existing HL7 FHIR® standards and implementation guides.

HL7 applauds the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) for its April 22, 2024 Common Agreement Version 2.0 release, which announced the requirement for health information networks participating in the Trusted Exchange Framework and Common Agreement (TEFCA) to support the HL7 Fast Healthcare Interoperability Resources (FHIR^®) standard.