VitalTrax patient dashboard. An eCRF is an electronic case report form, a questionnaire used in clinical trials, in this case to gauge mobility and pain for clinical trial participants.
Zikria Syed, who previously co-founded and led NexDocs before selling it to Aurea Software, has started another company to support clinical trials — VitalTrax. This time, he wants to change the paradigm for doing clinical trials.
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He and his team have developed a nimble interface for executing trials that more closely resembles social media than traditional clinical research documents but still conforms to regulatory requirements.
VitalTrax fits into the broader sector of electronic Clinical Outcomes Assessment solutions, which is also referred to as electronic Patient Reported Outcomes, or ePRO. A report by MarketsandMarkets valued this segment at about $3 billion in 2015, but projects that amount will double by 2020.
The company’s software is used to collect data directly from the patients. It also automates the tasks of participants in clinical trials such as informed consent, meeting appointments and reminders for both principal investigators and participants, and payment processing. Syed added that the platform is also designed to respond to the push to enlist digital health technology in clinical trials for remote monitoring of participants.
The software is also designed to give the same user interface on a desktop as it does on an Android or iPhone or tablet and switch between them. So far, Syed said his team has received positive feedback for the interface. VitalTrax already has one customer, The One Health Company, a contract research organization, and aims to have several more across pharma and CROs before the end of the year.
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His company’s approach reflects the consumerization of the user experience, Syed explained. That’s why he decided to allow those who use its clinical trial platform, from site managers to patients participating in a clinical trial, to apply the same credentials as their social media accounts like LinkedIn, Facebook or Google. It’s referred to as the Open standard for authorization or O-auth protocol.
“It is about patient centricity,” he said.
Ultimately, it will be for the clinical trial sponsor to decide whether to allow participants to use their social media credentials, but the point is that VitalTrax extends that capability to them.
Pharmaceutical companies have stepped up their patient engagement efforts in different ways. Some have added a point person on their teams to reflect that. Sanofi claimed to be the first big pharma to employ a chief patient officer. UCB has employed a chief patient affairs officer since 2012. Even medical devices companies are getting on board with Medtronic Diabetes having also employed a chief patient officer.
While these titles certainly look good from a marketing perspective, pharma companies are still struggling with issues like how to improve patient recruitment, particularly shortening the time it takes to find appropriate participants, which would help bring down clinical trial costs.
Those are the kinds of challenges where companies like VitalTrax see a place to provide relief through technology. Syed aims to emulate Medidata and Veeva, two companies he admires and believes have been successful in using technology to reduce the complexities of the pharmaceutical industry..
Clinical trials are a kind of black box with patients participating in trials without knowing whether the drug they were on was later approved. Or even what impact their participation has on the overall trial. This is what Syed aims to change.
“Historically, pharmaceutical companies have done a poor job of informing patients about the status of the clinical trial that they are participating in,” he said. Our goal is to educate the patient on the protocol and the status of the research so they know how it is progressing and what the eventual outcome for the study is. In addition, we would like to inform patients about their participation and encourage them to participate in a timely and consistent manner by introducing concepts like gamification, where patients earn points and rewards for active participation.”
Syed added that VitalTrax will also customize the user experience for trials to match demographics of the participants. As an example of what that could look like, he points out that for older adults, the technology would provide large fonts and a simple user interface to improve engagement and increase compliance.
Technology isn’t the be-all end-all of patient engagement, Syed acknowledged. But having a platform that treats patients like partners in clinical trials and improves the patient experience is a critical element in achieving this goal.
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