New Approach Could Make Clinical Trials More Equitable and Accessible

What if you’re a cancer patient and your current treatment isn’t working? What if you were just diagnosed and want to know all your options before deciding on a treatment? In all likelihood, you and your doctor will start looking for relevant clinical trials.

Today, less than 8 percent of cancer patients participate in clinical trials. Finding the right trial can be a time-consuming, manual process for doctors and patients. It means sifting through possibly hundreds of trial descriptions to see if you’re eligible, as well as manually inputting your medical records into various websites.

If you live in a rural area, finding a trial within traveling distance adds to the complexity.  Smaller, community-based oncology centers often don’t offer trials or have only limited options. And your doctor may be unaware of trials conducted in other cancer centers—or lack the time to get online for hours and scan trial criteria.

To save time, patients and doctors can use trial matching services, which are offered by numerous organizations, including major cancer centers. Without data standards, however, it can be hard to compare their results across services. Data standards provide the formats and rules for allowing different types of data to work together, a feature called interoperability.

“We’re working on ways to make cancer care and clinical trial participation accessible to everyone across the country,” says Andre Quina, one of the leads for MITRE’s Standard Health Records for Oncology (SHRO) research program. “For example, we’re establishing open data standards and APIs [apps] that enable interoperability across clinical trial matching capabilities.

“The goal is to make trial matching more scalable, accessible, and equitable.”

Solutions Start with Access to Information

The core of MITRE’s SHRO research is mCODE™ (Minimal Common Oncology Data Elements). mCODE provides data standards and a common data language so doctors can access and analyze patient treatment data from millions of cancer patients. Our technology pulls valuable information from the electronic health records (EHRs) that provide data on which treatments worked best for specific demographics.

Born in MITRE’s independent R&D program, this search for using shared data to improve cancer care drew together a coalition of organizations that developed mCODE as an open-standard nonproprietary data model. A large and growing research effort—which combines mCODE and Fast Healthcare Interoperability Resources (FHIR®)—has ongoing pilots in health systems across the country working to validate its value as a method to provide needed data to clinicians and patients.

Equitable Clinical Trial Matching

Can mCODE improve the clinical trial matching process and make trials more accessible to all cancer patients? 

“We believe it can,” says Salim Semy, one of MITRE’s leads on this project. “The American Cancer Society Cancer Action Network [ACS CAN] came to us with the idea, and we now have a team of partners, including health systems and vendors, testing the approach.

“We’ve employed mCODE data elements to provide a standard way to share patient data with clinical trial matching services that are in the business of identifying trials for patients. This approach cuts down on hours of manual entry as the data is pulled directly out of the EHRs—the authoritative source—and sent to clinical trial matching services.”

Semy explains that the trial matching services then send back a list of potential trials for which the patient may be eligible in a standard form. “That list is aggregated across multiple trial matching services and shared with the patient and provider.”

Working in Partnership

To bring together organizations that want to apply mCODE to particular use cases—such as trial matching—MITRE created an organization called CodeX™ (Common Oncology Data Elements eXtensions). CodeX, which lives within the Health Level Seven International standards-developing organization, offers a space and structure for partners to share knowledge and resources and pursue joint research.

ACS CAN and MITRE lead the Integrated Trial Matching for Cancer Patients and Providers team, which is defining and testing methods to reduce the barrier for patients and providers to find relevant trials.      

The team seeks to demonstrate the ability of a trial matching service to receive an mCODE record, analyze the record to match against a database of clinical trials, and then present the matches back to the patient/doctor in a standardized way.

First, the team had to determine which elements would provide the best filtering across clinical trial databases.

“We wanted to keep it simple, not perfect,” Semy says. “Our filter allows patients or clinicians to go from reviewing hundreds of trials to tens of trials to ultimately find a match for patients.”

We’ve also created user interfaces for patients and providers, and we developed standards and documentation that trial matching services can use to become mCODE-enabled.

The team is now conducting two pilots to further investigate the effectiveness of this approach and our user interfaces for patients and providers. In a pilot with Cancer Insights, patients will be able to use mCODE to pull their health records into the mCODE-enabled matching services. In another pilot, the University of Texas Southwestern will provide trial data we can use to test our matching process.

In the next, larger pilot, we will make our clinical trial matching approach available at a health center’s point of care to support patient/provider decision making.

Increasing Clinical Trial Enrollment

Adding to the number and diversity of participants would increase the value of the data that trials produce by representing a larger portion of the population.

“To be successful, cancer clinical trials must have a diverse pool of participants,” says Mark Fleury, policy principal for ACS CAN and a member of the CodeX team. “Yet a lot of patients who would be eligible to enroll are never given the chance often because they’re being treated at smaller, community-based oncology clinics that may not offer trials.

“If we make it quick and easy for these providers to locate potential trials for their patients—without creating additional steps or systems—we could increase and expand trial enrollment to many more people.”

The Integrated Trial Matching for Cancer Patients and Providers team now includes ACS CAN (co-champion), MITRE (co-champion), TrialScope, Massive Bio, BreastCancerTrials.org, Cancer Insights, TrialJectory, the University of Texas Southwestern, and Patient Link.

The team is looking for other partners who are interested in participating in this research. There are several other CodeX teams working on other mCODE use cases, including radiation therapy, prior authorization, and genomics data sharing.