One of the persistent problems in the clinical trials industry is that of low patient enrollment. If a trial fails to enroll enough patients, researchers are unable to draw a statistically meaningful conclusion about the study or are forced to close it altogether.
This happens frequently. According to a study published last year in The Journal of the National Cancer Institute, 18% of publicly funded clinical cancer trials either closed with low enrollment or had accrued less than half of their target enrollment three years after the start of the clinical trial.
With that problem in mind, Philadelphia-based VitalTrax has launched a commercial product called Wing—a clinical trial network designed to provide patients, caregivers and physicians an efficient, streamlined way of finding and enrolling in clinical trials.
As described by VitalTrax, Wing provides trial sponsors and research sites a venue to publish and promote their trials, as well as the tools to interact with and enroll patients.
“By addressing the unique needs of the entire ecosystem—patients, research sites and sponsors—Wing creates a seamless clinical trial network that facilitates enrollment and participation of patients in clinical trials,” VitalTrax stated while announcing the launch.
“A clinical trial is basically the engine that brings a new drug to market,” said VitalTrax founder and CEO Zikria Syed. “But there are a lot of inefficiencies in the clinical trial process that create a bottleneck that prevents new therapies from coming on the market, and the lack of patients is the number one reason for delays and failures of clinical trials.”
According to Syed, there are no effective and efficient ways to find, enroll and participate in clinical trials. VitalTrax’s Wing is a solution designed to help solve that problem.
Syed believes that Wing should work the way OpenTable works for the restaurant industry, bringing efficiency to a patient’s ability to find an appropriate trial and enroll in it.
Patients who go to the online platform can fill out a profile, which is then used to submit applications to one or more clinical trials. “We help them with the enrollment process, but we can also update them throughout the clinical trial,” Syed said. “Wing can be used to notify patients about their upcoming visits, adherence notifications or trial milestones.”
The problem with the clinical trials industry and the patient enrollment issue is that “everyone thinks short-term,” Syed said. “Sponsors or sites will market trials on a case-by-case basis, he added, but they’re not investing the same effort in creating awareness on the part of the patient or creating the tools for that will enable a patient to be proactive in looking for trials.
“We are really looking at the same problem from a completely different angle,” he said. “The demand is there, so let’s build the supply by educating patients rather than fighting over the same patients.”
T.J. Sharpe of Fort Lauderdale, Florida, is a stage IV melanoma survivor and patient advocate who has participated in two clinical trials. He speaks from experience when he describes some of the inefficiencies involved in the patient engagement aspect of clinical trials.
What VitalTrax is offering is “not entirely an unmet need,” said Sharpe, who also serves on VitalTrax’s Advisory Board. “There are people out there trying to do this. But the unmet need being filled [by VitalTrax] is that this hasn’t been done very effectively.
Sharpe points out that a site like ClinicalTrials.gov has been the most obvious source of information for patients about clinical trials. “But it doesn’t have the best interface and can be difficult to navigate,” he said.
In addition, ClinicalTrials.gov is not necessarily the best source of up-to-date information about clinical trials, Sharpe said, noting that it may indicate a trial is pending when it’s actually open to new patients, or that it’s open to new patients when it’s actually full.
While Sharpe praised Wing’s interface—“It’s a piece of cake to find what you’re looking for”—the difficult part VitalTrax is addressing is that of “bad data.”
“What I like about what they’ve done is that [Wing] also gives sponsors a stake in the game,” Sharpe said. He pointed out that sponsors and trial sites can brand pages pertaining to their trials, and also have the opportunity to update information about them.
The clinical trials industry should be pushing patients toward trusted information sources about clinical trials, Sharpe said, and Wing has the potential to be a tool that is “widely accepted as a trusted source of information for all stakeholders, and a place that stakeholders would go to either get information or put information out there.”
However, he warned, while a site like Wing efficiently deals with the patient engagement side of clinical trials, the solution to the bad data issue will “only be as good as what the source data is.”
Unless clinical trial sites and sponsors update their data on a real-time basis, “you’ll only get incremental gains,” Sharpe said. “But there’s no reason in the world that the most important industry in the world—healthcare—can’t do it with the resources it has available.”