How Digital Technology Is Transforming Clinical Studies

Source: Adapted from Forbes July 24, 2018 (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.

Last year saw the launching of a mobile application ClaimIt™ the company behind the app says is poised to transform clinical studies globally. According to ObvioHealth, a full-service contract research organisation (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.

The app 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 result is robust data collection, increased compliance, faster time to completion and significant cost savings compared to traditional site-based trials.

Clinical studies assisted by such applications will improve convenience for study subjects, enhancing compliance, lowering drop-out rates and accelerate data capture. All of these factors will help reduce costs for study sponsors and create opportunities to leverage data captured from connected devices for clinical evaluation.

The ClaimIt™ app digitises 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. Such technology empowers and enables patients who are typically silent, is more patient-centric and democratises clinical trials.

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 app–providing realworld 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 such as Danone and General Mills are early adopters. Real-time data collection assisted global food products corporation Danone to measure baby’s crying and fussing sounds to determine the difference between cries of hunger, laboured breathing, soiled diaper, etcetera. Such data wouldn’t have been captured previously.

The mobile app takes advantage of the FDA’s adaptive design concept as well, wherein a trial can be course-corrected mid-study. 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. 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.

The transformative impact such technology is having on the industry is just getting started.

Indeed the era of Artificial Intelligence (AI) and machine learning has increased the way companies are able to recruit participants for clinical studies. Adaptive study designs, enabled by machine learning, allow participant recruitment behaviourally as well as inclusively and exclusively through Targeted Digital Outreach (TD). Clinical psychologists create algorithms and questionnaires that 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 utilised to comb social media, including blogs, to identify words people are using in order to develop a target recruiting map.

Targeted social media advertising is used 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. Those who qualify are forwarded to the next level where a study team member may contact them to validate responses. Those who do not qualify for the study that peaked their initial interest are invited to join the 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:
• Privacy policy
• Data gathering and usage
• Study tasks and surveys
• Time commitment
• Option to withdraw
Engaging and educating stakeholder groups is essential to the successful deployment of such technology. Educate4Health (www.educate4health.com) are expert in developing interactive content that engages stakeholders such as healthcare professionals and patients.

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