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!  

Webinar Highlights Real-World mCODE®-Compatible Structured Data Capture at University of Wisconsin Madison

At the September CodeX Community of Practice, which will be held on Friday, Sept. 29, 2023, 12 – 1 p.m. ET, Dr. Hamid Emamekhoo will present their approach to enhance structure data collection at University of Wisconsin Madison.

In his presentation, “Charting a New Course: Transforming Oncology Documentation to Enhance mCODE-Compatible Structured Data Capture,” he will discuss the process of creating optimized oncology specific note templates to prioritize the collection of encounter-specific treatment and disease-related data in a standardized manner. They focus on integrating data collection into the routine clinical workflow and improve the accuracy and quality of clinical documentation while collecting mCODE (minimal Common Oncology Data Elements)-compatible structure data that can ultimately improve the quality of care and patient outcomes.

The mCODE FHIR Implementation Guide is an open standard language for cancer data. Once adopted across the oncology community, mCODE promises to greatly increase the amount of high-quality shareable data for all cancer types, allowing data to be collected once and used for multiple purposes by clinicians and researchers to support patient care.

Two CodeX HL7 FHIR Accelerator use case teams are hosting monthly public calls to involve a broad community in early prototype development and pilot planning activities currently underway.

The CodeX HL7 FHIR Accelerator will host three public calls next week covering project milestones in the Radiation Therapy Treatment Data (RTTD), Risk Evaluation and Mitigation Strategies[i] (REMS) and Prior Authorization in Oncology use cases.

• Join the CodeX Prior Authorization in Oncology team on February 15 (3-4 ET) for an update on its radiation oncology pilot planning. Use case team members will discuss progress relative to breast and prostate cancer patient demographic and clinical data elements discovery and health data standards mapping (e.g., mCODE and Da Vinci Project implementation guides). Find call information here.  
• Join the RTTD team on February 16 (11-12 ET) when they will share recent project achievements, including experience exchanging synthetic patient data using mCODE from a radiation oncology information test system to a FHIR server. Find call information here.
• Join the CodeX REMS team on February 17 (1-2 ET) to explore the value of an interoperable REMS ecosystem using FHIR and other health data standards, view details of the open source REMS on FHIR prototype under development and discuss CodeX membership details and benefits, including driving the REMS use case work forward. Find call information here.

The CodeX team believes the Minimal Common Oncology Data Elements (mCODE™) standard could be leveraged to achieve more equitable health outcomes for cancer patients from diverse populations. As part of our exploration, we are releasing a white paper, “Advancing Health Equity in Cancer Research, Care, and Surveillance,” available here and will host a companion webinar, "Leveraging Interoperability to Drive Health Equity in Cancer Care, Research and Surveillance." Please join us on January 27, 2022 at 1PM ET by registering here.