In this month’s Clinical Trial Conversations blog, we look at “Blue-button” trial matching, a new tool with the potential to help patients with cancer overcome one of the main barriers preventing them from participating in clinical trials. Maia Walker, lead curator of Fight Colorectal Cancer's Clinical Trial Finder, interviewed Mark Fleury, PhD, policy principal for the American Cancer Society Cancer Action Network (ACS CAN) and lead investigator on the project, and Sharon Shriver, PhD, project manager, Science Policy, at ACS CAN, to learn about the project. 

Clinical Trials Day is celebrated on May 20 to recognize the day that James Lind, a Scottish surgeon working on a ship, conducted what is often considered the first randomized clinical trial in 1747, while looking for a viable treatment for scurvy, a condition that he came face to face with while out at sea. The sailors in the ”two oranges and a lemon” “arm” of the trial were the only ones who improved.

Clinical trials design evolved further during the 19th century with the introduction of the double-blind trial and during the 20th century with the inclusion of placebos. During this 21st century, the use of computer science and information technology keeps reshaping the clinical trials landscape. In this conversation, we learn more about one of these initiatives. 

In just a few words, what is the “Blue-button” Project? Is it a new matching service?

Mark: Blue-button matching is a new tool that can automatically identify relevant clinical trials through one-button clinical trial matching integration within electronic health records (EHRs). With just a few clicks in a medical record, this tool has the potential to quickly identify comprehensive trial availability within the region, and by doing so will increase opportunities for patients to maximize access to the latest cancer innovation within their community.

Sharon: It is not a new matching service. The Blue-button tool is unique as it connects EHRs to existing trial matching services, rather than creating a new matching service. This integration into the EHR puts the function into the workflow of providers and allows accurate, automated local and regional screening to occur.  

That certainly sounds impressive. You mention “region” and “community.” We know that location of the clinical trial is often a key aspect for most patients looking to enroll. How could this tool help? 

Mark: In an ideal situation, the right clinical trial would be available for each patient at the site where they receive their care. But even in academic research centers, that’s not always the case. On average, only one in four patients will be eligible for a clinical trial available at the institution where they are being seen. This lack of onsite matching trials has been identified as the single largest barrier preventing patients from participating in clinical trials. But an appropriate trial might be offered at a neighboring institution, or in the next town, so we want to look in a broader area than just one institution. The Blue-button tool allows a user to designate a search radius, to find trials within a local region or farther away. 

What happens most often today is that if no trial is available at the site where the patient is being seen, the only other option to find a trial typically involves the use of third-party clinical trial matching services such as ClinicalTrials.gov or various patient advocacy services like Fight CRC’s Clinical Trial Finder. These services yield few enrollments because they require significant effort on the part of patients or clinicians (who may not be aware of their existence), and information to match patients to trials may be incomplete. The Blue-button tool was created to help address this gap. 

Sharon: One of our hypotheses is that the use of the Blue-button tool will ultimately not only increase clinical trial enrollment, which is so important for the development and testing of new cancer drugs, but will also lead to increased diversity of clinical trial participants. We know that more than half of all patients with cancer agree to participate in a clinical trial when offered the opportunity, but that few patients are provided the chance. We hope that the Blue-button tool will provide those opportunities to a larger and more diverse group of patients.

How is it being developed? How does it work?

Sharon: The genesis of this project was a 2018 landscape report created by a group of stakeholders – including Fight CRC– convened by ACS CAN to identify barriers to clinical trial enrollment. A later meeting that drilled into some of the recommendations related to the trial matching ecosystem yielded the idea of Blue-button. There was a lot of refinement of the idea, and then the initiative really took off when ACS CAN partnered with MITRE, a not-for-profit organization working in the public interest, through CodeX, one of the HL7® Fast Healthcare Interoperability Resources (FHIR®) Accelerators, to create the tool’s functionality. CodeX is a member-driven community and platform to accelerate interoperable data modeling and implementation around mCODE (minimal Common Oncology Data Elements, an open standard language for cancer data), leading to improvements in cancer care and research. The Blue-button tool provides basic trial screening within EHRs by sending a select number of de-identified, standardized patient data elements from the EHR (or entered by a provider) to external clinical trial matching services that then return the results for any matching trials within the region. 

Let’s talk about that. During 2022, Blue-button was in the testing phase for technical validation of the tool. A set of de-identified, archival patient data was used to assess the tool’s functionality. Please, tell us about that–how it was done, what you have found out. 

Sharon: We’re excited about the results of the technical validation study. We performed the trial eligibility screening using just eight patient data elements (such as age, cancer type and stage, and biomarker status) that we extracted from archival patient records representing several different cancer types, including colorectal cancer. A clinical provider then used the full patient record to confirm which trials returned by the tool fit the patient’s more complete profile (we call these “provisional" matches, since there may be additional eligibility factors that can only be assessed by individual review). We found that on average, about half the trials returned by the tool were provisional matches, and that the review of each trial took just a few minutes. So that suggests that the tool is effective in locating potential trials, and that from an effort standpoint, it’s feasible to use within the clinical workflow. 

Our next task was to test our hypothesis that searching for trials regionally did, in fact, provide patients with more options compared to looking at their health care site alone. Again, the results were encouraging: Compared to onsite trials, we saw an impressive net increase in the overall regional provisional match rate when we used the tool to search within a 20-mile radius of the urban, academic health center where the patient records were based.  

You’ll be launching a prospective study of the Blue-button tool for 500 patients, at different healthcare sites in the U.S. What are the goals of this study? 

Mark: For the prospective study, the Blue-button software will interface with the patient EHRs so that we can test the real-time, in-workflow functionality of the tool. The tool will now be tested with more than 500 patients combined at multiple locations. One of these is the University of Texas Southwestern (UTSW) Harold C. Simmons Comprehensive Cancer Center, an urban, academic center. UTSW will enroll colorectal cancer patients as part of the cohort, which will include five different cancer types overall. We're in discussion with other U.S. sites that may join the trial.

Patients who consent to participate in the study will be presented with clinical trials that are identified regionally by the Blue-button tool, and we will record whether they choose to participate and the factors that contribute to that decision. The roughly 12-month study will evaluate whether the tool can increase and diversify trial participation with minimal effort on the part of providers.  

So, what’s next for Blue-button?

Mark: We appreciate Fight CRC’s ongoing participation in the Clinical Trial Barriers advisory group that continues to support this work with feedback and expertise. Watch for upcoming publications on the background work and technical validation study, and we will share news once we have actionable data from the prospective clinical trial, hopefully by the end of 2023.  

We look forward to hearing about it!  It was a pleasure meeting you, Mark and Sharon! Thank you for your time. 

Stay Tuned for More!

Once a month, Maia and Manju spend time unpacking important research trials, tips, and advice for our community. Be sure to subscribe to sign up with Fight CRC and join COLONTOWN’s online community to continue receiving the most relevant updates in the CRC world!

You can also follow Maia (@sassycell) and Manju (@manjuggm) to stay updated on research and trials and visit ClinicalTrials.gov for more information on trials.

Clinical trials are critical to finding a cure for colorectal cancer. As an advocacy organization dedicated to supporting and empowering a community of patients, caregivers and families, Fight CRC has partnered with COLONTOWN to deliver a monthly blog series highlighting everything patients need to know about clinical trials and the best treatment options available. 

In this series, we hope to cover promising trials that are enrolling, lessons learned from past research, logistics and resources to joining a clinical trial, and provide relevant and timely updates for our colon and rectal cancer community. 

Be Sure to Check Out These Fight CRC Resources:

Clinical Trial Finder

• Colorectal Cancer Clinical Trial Finder
• Colorectal Cancer Clinical Trials Brochure  

More Clinical Trial Conversations

• Fireside Chat About Clinical Trials
• Clinical Trials for Early-Stage Colorectal Cancer or Minimal Residual Disease
• 2023 GI ASCO Clinical Trial Studies
• ESMO 2022 Research Update: A Patient Research Advocate Viewpoint
• Recruiting Phase III Clinical Trials for Colorectal Cancer