Pharma

Improving DCTs through Patient, Site, and Sponsor Centric Approaches

By 2025, 60% of life science organizations will use health data platforms for physician engagement and patient journey processes1. In the wider landscape of emerging digital healthcare technology (DHTs), mobile apps in clinical trials have become instrumental in ensuring protocol adherence, recruitment, and patient engagement.

However, delivering a clinical trial app that patients will engage with and consistently use requires far deeper insights into their trial journey. These apps must also be built on technology that has been proven, be used by the majority of sites, and provide measurable benefits for Sponsors and CROs.

With the global launch of the myMedidata mobile app, Medidata leverages years of its Patient Insights intelligence to deliver a unified app experience across eCOA, live video visits, eConsent, Registries, Sensors, and more. Unified with the Medidata platform, which connects patients, sites, and sponsors in a secure and scalable cloud environment, it eliminates workflows, expedites timelines, and mitigates risks. Moreover, the new app is the first to employ Medidata Designer, allowing for Sponsors and CROs to access global libraries and translations, dramatically accelerating study start timelines and allowing sites to enroll patients faster.

Built for Patients by Patients

Patients are the end-users of clinical trial solutions, and the best experiences for patients ultimately bring the most value to everyone involved in running clinical trials.

Leveraging the Medidata Patient Insights program to infuse the patient perspective into a more patient-centric technology development life cycle, the myMedidata mobile app is the first to incorporate the patient voice into an app design.

Using the latest patient-facing technology, patients can download and access the application on their iOS, Android, or a provisioned device to enable them with a central location where they can interact with all their study activities. They gain the flexibility to choose how to participate and the ability to engage in trial activities while at home or on the go. The app represents another option for patients enrolled in Medidata-supported clinical trials.

To help ensure their trial participation fits seamlessly into their day-to-day life, patients can also fill out forms via a web browser, allowing them to provide data in real time in a way that’s most convenient for them. The myMedidata mobile app also enables patients with the latest device technology for ease of use. Through their myMedidata account, a single login and/or biometric access (Face ID or Touch ID) gives access to all their trial activities through the web or the app.

In designing the new app, the digital experience had to empower patients with seamless, end-to-end, and easy engagement throughout their trial journey.

“When they get to the study home screen, patients can see their upcoming scheduled activities or as-needed activities. They can also navigate to the all-activity screen to view what they have already completed,” says Kris Chua, Senior Product Manager, Patient Cloud, Medidata, a Dassault Systèmes Company. “They can receive alerts and notifications for the next steps in their trial(s) and be directed to their next task.”

Vetted by the Medidata Patient Insights Board, the myMedidata mobile app is a fundamental example of Medidata’s commitment to empowering patients and lowering the burden of the clinical trial experience.

Building Beyond eCOA

By enabling patients to find, learn about, and enroll in a study, as well as share data in real time across all clinical trial activities in one location, the new app also offers huge benefits for sites and sponsors.

Unifying capabilities across all of Medidata’s patient-facing technologies, the myMedidata mobile app is built on top of Medidata Designer, the new Medidata platform configuration tool.

Medidata's Designer provides study builders with the flexibility they need to customize all key aspects of eCOA. Beyond just designing and creating eCOA, the new tool will support ancillary workflows that are required to get an eCOA study up and running, such as translation management and form availability. Designer drastically lowers study build times by employing Medidata and client libraries including pre-built eCOA instruments, translations, and study configurations. As a result, study start-up times can be shortened by up to 50%.

Building the App of the Future

The myMedidata mobile app is the first app to deliver continuous engagement for patients pre-trial, in trial, and post-trial.

It is the first to integrate Registries that help patients learn more about clinical trial opportunities to expand participation from a single trial transaction to pre-and post-trial engagement, resulting in a community of educated, empowered, and engaged patients.

“Many apps are just a one-way interaction. They are very transactional, neither intuitive nor proactively supporting patients and study teams,” adds Paul O’Donohoe, Senior Director, eCOA Product and Science, Medidata. “They log into one app, and it informs and guides them through exactly what they need to know and what they need to do next. We're not just extracting data from the patient, we are providing something back—visibility, safety, and security—that ultimately will make a difference through their journey.”

The myMedidata app realizes the value of patient-centric mobile health apps. It is the path to informing real-world evidence and improving patient empowerment, clinical management, and treatment development by driving data quality, motivation for long-term use, privacy and security, technology integration, and standardization.

The myMedidata mobile app was introduced during the Medidata NEXT conference, held in New York City November 15-16, 2022. For more information, please visit myMedidata app.

1. IDC FutureScape: Worldwide Life Sciences 2023 Predictions

The editorial staff had no role in this post's creation.