Patient-friendly sensors and wearable technologies are now so ubiquitous that we can take advantage of them in clinical trials to measure voice, movement, life space, cognition, mood, activity, medication, use, and biometrics. Yet, it’s not as easy as throwing a wearable into a clinical trial and hoping for the best clinical user experience. Ensuring that the device supports diverse trial participation, creates better engagement, reduces user anxiety, and builds trust requires applying user experience (UX) design principles and practices to improve the patient experience in clinical trials.

How to Develop and Implement Good UX Design

Good UX design in clinical trial technology follows a carefully developed process that requires an interdisciplinary team with wide-ranging experiences, perspectives, and expertise. The figure below illustrates the stages of development that are involved in engineering wearable or sensor technology for a study. Note that attention to the user experience appears as a constant—from conceptual design all the way through to the maintenance stage.

Conceptual Design

Patients
Clinical
UX
Engineering
Data
Regulatory needs

Design Development

Patients
Clinical
UX
Engineering
Data

Production

UX
Engineering
Data
IRB

Launch Remediation

Patients
Clinical
UX
UAT
Engineering
Data

Maintenance

Patients
Clinical
UX
UAT
Engineering
Data

Good UX design takes into consideration the needs, abilities, and preferences of the target patient population; the clinical needs of the trial; and ultimately how the data will be analyzed. At Clincial ink, we work hard at this stage to fully understand the research goals. For example, if the application is to replace a paper diary, it’s important to not simply strive to replicate any paper form, but to understand the initial data capture goals behind the paper form.

How we Approach Good UX design at Clinical ink

The advanced technology and data sciences team at Clinical ink strongly believes in developing workflows, storyboards, and high-fidelity illustrations at the conceptual design stage to help partners visualize the tool and how it will be experienced by the patient. In tandem, we further refine this patient experience by conducting natural history studies to ensure that basic patient information, like quality-of-life factors, are designed for.

Ideally, the resulting design provides a single application that runs all the activities for the study, can be deployed in multiple modalities and across platforms (Android/iOS), and offers a seamless, engaging experience for the patient. Above all, this application should be intuitive; indeed, the gold standard for UX design is that it leads to a product that is usable, useful, desirable, findable (specifically, solutions to any product challenges can be found easily), accessible, and credible¹.

We’ve found that the best results integrate user-tested instruments, animation, calibration, and feedback directly into the study’s mobile application. Screen captures below from an electronic symptom diary illustrate how these elements can give patients all of the information and encouragement they need to complete assessments correctly. The instructions are clear, approachable, and thorough.  Our robust voice user research demonstrates that ensuring patients have the ability to practice, that they are alerted to any potential problem or interference, and that they can even listen to a preview of their recording ensures not only confidence in participation, but better data collection.

Summary of the Benefits of Good UX Design

Ensuring the best patient experience possible in clinical trials through careful attention to UX design pays dividends for drug sponsors.  When applications of sensors and wearable technology  are engaging and user friendly, they support greater trial participation and stronger protocol compliance, which has a direct impact on data quality as well as integrity. Adopting best practices in UX design also furthers the goals of health equity, ensuring that all can participate in research by reducing barriers and reducing the possibility that important information is excluded.

Learn more about how to harness the power of sensors and wearables in your clinical trial.

 ¹User Experience Design (semanticstudios.com)

Author

Joan Severson
Chief Innovation Officer,
Clinical ink

The post UX Design: A Prerequisite for Deploying Wearables and Sensors in Clinical Trials appeared first on Clinical ink.

Starting the week of March 15, Clinical Ink’s overall system usage showed a steep decline in new patient enrollment and a modest but steady decline in existing patient activity. Notably, the last two weeks have shown a stabilization in existing patient activity at about 65% of the levels seen in February and new patient activity has rebounded slightly to about 20% of prior levels. Site activity (measured by unique and total user logins) has also been constant over the last month at about 70% of prior activity levels, indicating sites are doing their best to maintain patient data and respond to remote monitoring requests even while working from home.

“This is a time to show that patients actually matter — it’s not just about money,” said Clinical Ink CEO Ed Seguine. “Clinical Ink is putting patients first by proactively waiving potentially millions of dollars in change orders so that new and current studies can continue without our customers having costs increase both now and in the long run. Beyond the financial implications, we are changing how we approach our service delivery — including deploying a new direct data capture (DDC) study in just 15 days for a novel COVID-19 treatment option. All of us feel a heightened sense of uncertainty right now, but we view this as a compelling moment to show our commitment to customers and patients in a meaningful way. I invite other clinical technology and service providers to make a similar pledge so that our combined efforts can help ensure patients truly do come first.”

In anticipation of the likelihood that current studies will be delayed, Clinical Ink’s Study Assurance Program includes contracting adjustments for all current and new studies:

1. Change order waiver of all platform licensing and help desk fees for a period of up to three months for all current and new studies.
2. Project management fees specifically related to implementing bring your own device (BYOD) ePRO deployment will be waived (e.g., IRB approvals, scale license provisioning, device management plans).
3. Help desk services to assist patients struggling with “virtual visit” technologies will be offered at no additional charge for the duration of the study.
4. Logistics options have been expanded to include provisioning phones, tablets, and internet connectivity directly to patients in need.

“Our customers rely on our experience, capabilities, and technology to ensure the science behind their study protocol is reflected in the patient data itself,” said Clinical Ink Chief Business Officer Jonathan Andrus. “The business of drug development is expensive and uncertain — plans frequently change. Fortunately, Clinical Ink’s technology platform offers the broadest range of capabilities for clinical trials to succeed in a post-COVID-19 world. We want to succeed commercially based on our platform capabilities, not on change orders. The Clinical Ink Study Assurance Program is our way of sharing the responsibility we all have to work together in a new normal.”

About Clinical Ink

Clinical Ink, a global clinical technology company, offers data certainty from source to submission. Our Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO, and eConsent modules — a suite of solutions for capturing and integrating electronic data from sites, clinicians, and patients at its source — naturally enhance your clinical trial workflow by reducing manual labor, providing anytime, anywhere data access, and saving resources as your trials progress.

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