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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Today, most patients who enroll in clinical trials learned of these opportunities from their provider or trial staff where the patient is receiving their care. This is problematic for several reasons:

• Patients and their care teams miss the opportunity to consider and enroll in a promising trial if it’s not offered in their home care network
• If a patient is working with a care team at a health system where no trials are available, they may not be offered the opportunity to participate in any clinical trials at all
• Patients (and their caregivers) are often left on their own to navigate a complex online landscape to find a clinical trial. They may need to tackle manual entry of their own medical history into multiple, disparate tools. To determine their own eligibility, patients are challenged to interpret sophisticated medical concepts and pore through research terminology that can vary widely* across protocols

Care teams do not have the tools built into their workflow to allow for efficient clinical trial matching outside of their own health system, and often within it. Third party matching services exist, many relieving the burden by acting as a concierge, however, they are also limited by the challenges of data availability described above.

Toward a Better Future State...

Two separate-but-related HL7 FHIR Accelerators (CodeX and Vulcan) 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. Read Part 1 for details.

We believe FHIR can enable better access to, and processing of, the information needed to achieve trial matching – resulting in more research options presented to each patient in near real time.

While the patient’s well-being is at the heart of what we do, we must examine this trial matching problem from multiple stakeholders’ points of view. There is no magic bullet. The ideal future state will also require transformative change in several areas that complement the progress in data processing – including institutional workflows, integration into consumer facing user interfaces, and support via policies that govern access to patient data.

Imagine… Dr. Smith’s patient, Michael, is seeking to participate in a colon cancer clinical trial. Within days of their discussion, Dr. Smith retrieves Michael’s medical records in an organized, digital format that makes it possible to automate the comparison against the criteria for multiple trials. Michael recently moved to the area, but that does not cause any delay - his medical records from his previous provider were easily accessible and included in the review. Because the clinical trial protocols were digital and easy to search, multiple clinical trials at Dr. Smith’s current hospital and within a 30-minute radius (per Michael’s request) are presented as options. Michael and his doctor discuss the best matches and begin the process. Michael and Dr. Smith have hope.

Engage with Us!

CodeX

Better Data. Better Health. Stay connected with the CodeX community.

• Join the CodeX mailing list here.
• For more information visit our home page, or contact the CodeX Program Management Office at pmo@hl7codex.org.

Vulcan

Bring clinical research to the point of care. Partner with Vulcan to contribute to the utility and adoption of the digital clinical protocol.

May HL7 Connectathon

• Participate hands-on at the HL7 Connectathon, May 10-11, as we perform further testing and business process exploration required to ballot and publish the FHIR IG.  Sit at the table with system developers, FHIR experts, clinical trial sponsors and business process experts as we aim to:
   
  • Refine eligibility criteria representation
  • Improve data bundling strategies
  • Explore the use of FHIR extensions
  • Validate the alignment of terminology across ICH M11, USDM, and FHIR

Both technical and non-technical participants are encouraged to join to ensure the FHIR IG aligns with real-world implementation needs and use cases. See firsthand how trial criteria and protocol data can be structured and shared efficiently. Gain insights into tools and methods that make trials more scalable, interoperable and future proof. Learn more here.

Register here. Early bird registration is available through Friday, April 18, 2025.

Join the UDP Efforts

• Attend our UDP public webinar series. Follow Vulcan on LinkedIn or monitor our site to be informed of upcoming events and access past webinar recordings.
• Express interest to UDP@HL7Vulcan.org.