NEW YORK – Digital health startup TrialJectory found through a recent survey of US cancer patients that while most understood the importance of using genetic testing to guide treatment decisions, less than half had undergone multigene next-generation sequencing (NGS) to identify actionable biomarkers during the course of their treatment.
The survey, sent out to patients enrolled in TrialJectory's patient-facing, free, online clinical trial matching platform, received just under 10,000 responses, representing about a third of the patients enrolled in the platform at the time. The survey revealed that while 90 percent knew genetic testing was critical to personalizing their care, only 46 percent had actually been tested for multiple markers using an NGS panel.
"This was an indication to us of how important the topic [of biomarker testing] is to the patients and how much they're aware of it and want to gain as much information as they can," TrialJectory CEO Tzvia Bader said of the high response rate. The survey also asked patients if they would be interested in TrialJectory helping them receive multigene NGS testing — something that the three-year-old startup does not currently offer — and some 70 percent of patients said they would.
Bader is hopeful that the insights gleaned from TrialJectory's recent survey will catalyze much-needed action from providers, patients, and sponsors alike when it comes to improving biomarker testing rates. Several studies at the American Society of Clinical Oncology's annual meeting in June reported lower multi-gene testing rates, particularly among Black patients. A number of reasons have been cited for this access gap, including limited patient awareness. TrialJectory's survey results showing 90 percent of patients understood the importance of biomarker testing, however, run counter to that narrative.
In fact, patients most commonly said they didn't get tested not because they didn't know about it but because their doctors felt testing wouldn't identify actionable markers or because insurance wouldn't cover it. "It's not lack of awareness," Bader said. "Not from the patient side."
Accordingly, the New York-headquartered firm is exploring partnerships with diagnostics firms and other strategies to help patients get access to NGS testing. "We're not going to become a testing company," Bader said. "Our focus and technology are centered around becoming a decision support platform. But partnerships … [are] something we're exploring right now."
The latest survey spotlighting biomarker testing access gaps is also important information for trial sponsors to know since currently, patients often access biomarker-informed treatment in a research context. TrialJectory launched in 2018 with a mission to remove barriers for patients looking to enroll in clinical trials.
Patients can sign up online and share their clinical and personal information such as location, demographics, ethnicity, and the stage, type, subtype, and molecular characteristics of their cancers. Based on this information, TrialJectory matches patients to clinical trial options, which the firm's algorithm pulls from databases such as clinicaltrials.gov and similar open-access databases of current clinical trial protocols. Trial databases such as clinicaltrials.gov, Bader explained, are not always easy for patients to navigate. The eligibility criteria are not immediately clear to patients when visiting a trial's page, and investigators don't input trial details in a standardized format or in patient-friendly language.
"We pull all trials from these open databases and then our artificial intelligence engine runs on top of them, structures them, and standardizes them so that we can show patients all the trials they might potentially match with," Bader said, adding that the match results are "bias-free," meaning the algorithm recommends trials regardless of whether TrialJectory has relationships with the studies' sponsors.
TrialJectory's relationships with drug sponsors, however, are a key component of its business model and mission. While the platform is entirely free of charge to patients, trial sponsors such as pharmaceutical companies can pay TrialJectory to access the wealth of deidentified information that patients enter into the system when searching for a trial. These data are invaluable for the sponsors, who can use them to help adjust eligibility criteria and improve their approach to clinical development.
"If you accept the new reality where patients are taking the lead on treatment decisions, you realize pharma companies don't really have access to or an understanding of this new decision-maker," Bader explained. "What do these patients' journeys look like? What are their motivations? What are the barriers they face? Right now, pharma companies are just making assumptions about those data based on claims data that may be out-of-date or incomplete electronic medical records data."
Drugmakers are also interested in increasing enrollment in their drug trials, many of which fail to take off due to too few patients meeting extensive exclusion and inclusion criteria. The prospect of broadening eligibility criteria can be a major draw for pharmaceutical companies, especially those evaluating drugs for rare cancer subtypes and struggling to enroll enough patients.
Bader cited the example of a clinical trial listed in the TrialJectory system that required patients to be disease-free for a specific period of time in order to enroll in the study. The platform's data showed the sponsor that around 25 percent of patients fell short of that requirement by under three months. Seeing this, the drugmaker reconsidered that requirement and adjusted the criteria, Bader said.
In addition to highlighting these insights to drugmakers, trial sponsors can build a "what if" scenario in the platform through which they simulate how the numbers of eligible patients would change if they altered certain criteria. While it is not always possible to alter eligibility criteria while maintaining patients' safety and the integrity of the trial overall, there are cases where the criteria can be slightly altered. Sponsors can therefore use the insights from TrialJectory's platform, such as the number of patients that would be eligible with criteria changes, and discuss the necessary amendments with the US Food and Drug Administration.
Currently, TrialJectory has entered partnerships with around 30 paying sponsors, although Bader said the firm expects to rapidly ink more partnerships in the coming months and years. "We are still in the early days," she said.
Currently, TrialJectory is growing its patient numbers by between 3,000 and 5,000 patients per month, primarily through online outreach and engagement with patient advocacy groups. The platform has capabilities to match patients to studies across a dozen cancer types, but according to Bader, the company will expand this capability in the near term, as well as the number of patients on its platform.