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:
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.
*About the Clinical Protocol:
Clinical trial protocols serve as the anchor for specifying clinical trial requirements and parameters. Historically, clinical protocols have varied widely. The language used, format and organization of these documents are often unique to the author and/or sponsor, complicating the process for downstream stakeholders executing the clinical trial.
In 2014, TransCelerate Biopharma, Inc. launched a workstream to address this challenge, enhancing clinical trial processes by developing common content for reuse across clinical trial documents. The Common Protocol Template (CPT) was developed and made available for industry use.
The CPT was foundational to the journey to protocol digitalization. Later, the eCPT was launched, spurring ICH M11 to pursue a protocol template and technical exchange specification - while the Digital Data Flow (DDF) multi-stakeholder collaboration, including CDISC and other stakeholders, developed a standard data model for the protocol.
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
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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
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.
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