FORBES Jul 24, 2018
By Robin Seaton Jefferson
When most people think of clinical studies, they think of cold, white, sterile spaces full of computers, test tubes and scientists. But imagine the possibility that your own smartphone is a lab of sorts, ripe for data entry and collection and the critical component of an ever-expanding scientific knowledge base.
ObvioHealth announced this week the launching of ClaimIt™ —a mobile application that the company says is poised to transform clinical studies globally. According to ObvioHealth—a full-service contract research organization (CRO) that uses technology to drive clinical research—the mobile app eases the challenges for both researchers and participants of conducting traditional clinical research by offering both 100% site-less clinical trials and the opportunity for “hybrid” studies where a brick and mortar environment is a requirement.
ClaimIt™ also removes the overhead costs for researchers and participants of physical site visits (if desired) and brings the trial directly to the participant’s mobile device. This open-ended communication also allows the study team to be continually connected to study participants. The company says the result is robust data collection, increased compliance, faster time to completion and significant cost savings compared to traditional site-based trials.
“The future of this software is that it will march in step with the future of healthcare, especially digital health, digital medicines and the smart x of everything,” said Bryan Silverman, CEO of ObvioHealth. He said clinical studies assisted by ClaimIt™ will not struggle with the barriers currently troubling the clinical research industry by improving convenience for study subjects, enhancing compliance, lowering drop-out rates and accelerating data capture. The company says all of these factors will help reduce costs for study sponsors and create opportunities to leverage data captured from connected devices for clinical evaluation.
Silverman said ClaimIt founders Dr. Michael Shleifer and Ivan Jarry of ObvioHealth’s parent company SPRIM set out to make a significant contribution to research capabilities by making clinical trials faster, more cost effective and available to everyone. ClaimIt™ digitizes the entire clinical research process while complying with FDA Good Clinical Practices, supporting observational and interventional studies, and allowing integration with smartphones, connected devices, and real-time interactions with subjects. “This essentially empowers and enables patients who are typically silent. It becomes patient-centric and democratizes clinical trials,” Silverman said.
Until now most clinical trials have been “slanted toward” those who live near a CRO, Silverman said, often sacrificing data collection from obscure or inaccessible areas. With ClaimIt™, he said, “There are no geographic boundaries, so I can go into very remote regions globally in China or Africa or India for research, or even in the U.S. into very poor neighborhoods. For decades, the clinical research industry has followed an archaic model, but now there’s a better option. Our mobile model challenges the industry to put patients first. ClaimIt™ allows study subjects to take part in important healthcare research from the comfort of their homes.”
Clinical research trials using ClaimIt™ are primarily conducted online, save for any trips participants need to make for blood draws, images, evaluations and other measures that might require a clinical setting. This decentralized model means clinical trials can be engaged in from a participant’s smartphone while leveraging the best-practices in study design, data management and medical writing. He said ObvioHealth maintains best-in-class clinical standards and compliance in studies ranging from pharmaceutical and nutrition, to behavioral and observational and more. ObvioHealth’s clinical professionals and medical doctors monitor each study while participants use the ClaimIt™ app on their smartphones or tablets.
Study protocols can be designed with smart devices, such as a Bluetooth blood pressure monitors; and the data from such devices immediately integrates with the ClaimIt™ app–providing real-world evidence. Participants record study-specific information in real-time which allows for 24/7 data collection and monitoring by researchers. Real-time data collection creates an environment wherein any adverse events are detected immediately such as reactions to study medication, and enables healthcare professionals to video chat or text with participants at any time.
Corporate brands such as Danone and General Mills are among ClaimIt™ clients. Real-time data collection assisted global food products corporation Danone when the company wanted to measure a baby’s crying and fussing sounds to determine the difference between cries of hunger, labored breathing, soiled diaper, etcetera, Silverman said. “Researchers wouldn’t have been able to get that data before unless the parent was living on the study site with the baby,” he said. “Danone already has machine learning, but [ClaimIt™] becomes the enabler for them to capture this data—capture real-world evidence as it is happening.”
The mobile app takes advantage of the FDA’s adaptive design concept as well, wherein a trial can be course-corrected mid-study, Silverman said. For example if the data is telling researchers that the study is going to fail with its current parameters, researchers can make alterations to the medicine dose or population size, for example. Insofar as any changes made are within the study protocol, or what the Institutional Review Board (IRB) approved before the study began, FDA requirements are met.
ObvioHealth also announced this week it had raised $3 million in series A financing round, led by TKS I, a life science and healthcare focused venture fund formed by Tikehau Investment Management (IM) and SPRIM’s corporate venture capital arm, SPRIM Ventures. Silverman said the money will help the company expand its operational team and support its current growth needs. “From consumer packaged goods, [to] pharmaceutical and consumer healthcare companies alike, our technology has now been validated through myriad studies,” he said. “And sponsors are seeing the incredible value of transitioning toward end-to-end digitally enabled clinical trials.”
“Thanks to technology, the clinical trial market is experiencing a disruption that will reduce the time and cost of drug development, for the benefit of patients, healthcare systems, and trial sponsors,” said Bruno de Pampelonne, chairman of Tikehau IM. “ClaimIt™ will help advance the latest treatments in healthcare, which is why we invested so confidently in ObvioHealth. We’re happy to see the technology come to fruition and believe its transformation of the industry is just getting started.”
To see how studies work using ClaimIt click on here.
Indeed the era of Artificial Intelligence (AI) and machine learning has increased the way companies like ObvioHealth via ClaimIt™ are able to recruit participants for clinical studies. Adaptive study designs, enabled by machine learning, allow ClaimIt™ to recruit behaviorally as well as inclusively and exclusively through Targeted Digital Outreach (TD), Silverman said. Clinical psychologists create algorithms and questionnaires that can—through predictive analytics—discover with 90% certainty which individuals are at high risk for dropping out of a study or for deviation from study protocol. Semantics analytics can recruit participants based on dialogue and can be utilized to comb the social media air waves, including blogs, to identify words people are using in order to develop a target recruiting map.
The company also uses targeted social media advertising to funnel potential participants to a study specific landing page. Each landing page contains details about the parameters of the study, the benefits and risks of participating and financial compensation.
Interested participants in a certain study, for example, complete an initial questionnaire to find out if they qualify for the study. Those who qualify are forwarded to the next level where a study team member may contact them to validate responses. The participant will then be invited to download the ClaimIt™ app. Those who do not qualify for the study that peaked their initial interest will be invited to join the ClaimIt™ Participant Database and receive invitations to take part in future studies.
Subjects are verified using government issued IDs, GPS authentication, photo and selfie IDs, fingerprint and facial recognition, query-based authentication and eConsent.
A series of screens explain the parameters of the study including:
To find more information on ClaimIt™, visit ObvioHealth’s official site here.
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