By Jeff Lee

June 5, 2018 | Clinical Informatics News Best Practices Award Finalist | In February, three entries were announced the winners of the Clinical Informatics News Best Practices Awards. Each year these awards are given with the goal of recognizing the projects that raise the bar on innovation in clinical trials. While only three projects are rewarded, we can’t help but recognize the remaining six finalists for their efforts in improving the clinical trial process for both patients and researchers. Here is one of those finalists. – The Editors

Collection of patient data is the lifeblood of clinical trials and a fundamental step in determining the efficacy and safety of an intervention. Keeping patients informed and engaged for the duration of a study is critical, especially when the study requires the patient to complete diaries and report outcomes in between site visits. Patients who feel their needs and perspectives are being considered are more likely to remain in the trial and compliant to their treatment program, while supplying the all essential data needed for study success.

As the patient centricity movement gains traction, the pharmaceutical industry is struggling to find patient-centric technology solutions that deliver on the promise to improve the patient study experience and keep pace with consumer expectations. It’s common for a single clinical trial to ask patients to use multiple systems and devices during their participation. While patient-facing technologies have proven to be valuable assets for engagement, retention, and data collection, offering too many different point solutions burdens the patient and means that the solutions in themselves can potentially become a barrier to study adherence.

Making patients feel like partners

The industry is at a turning point where it has a unique opportunity to challenge the patient engagement status quo by harnessing the untapped potential for single mobile apps to support and engage trial patients from start to finish. Bracket has developed an ePRO solution with the aim of making patients feel like “partners” in their clinical trial, rather than “data cows”. The mobile ePRO app enables patients to access everything they need to feel empowered and informed as they progress through a clinical trial, including survey instruments, personalized reminders (via text-message or push notifications), visit schedule information, multimedia reference tools, gamification, as well as direct-from-site communications. By eliminating the need for patients to use multiple systems to keep up with study requirements, this type of solution makes it easier to integrate study commitments into daily life, improving compliance and completion rates.

The barriers to patient recruitment, retention and protocol adherence can have a significant impact on clinical research. According to CenterWatch, the average dropout rate across all clinical trials is around 30%, highlighting the importance of technologies that make participation easier. Bracket’s ePRO technology harnesses the power of mobile to create a more streamlined patient experience. It gives patients a tailored, study-specific program that makes them feel important and connected to their study. Real-time data transfer between the patient app, sponsor, and site opens the lines of communication, and as a result, builds the patient’s trust in both the study process and their care team.

It has been proven that patients who use Bracket ePRO are more likely to comply with a study protocol and complete their diary entries, while being less likely to withdraw from the study. In a recent trial conducted by a top 10 pharmaceutical company, an evaluation of study dropout rates showed that patients who used Bracket ePRO were 80% more likely to complete the study than non-users.

Patient centricity is a priority for every life science company, however, very few solutions currently exist that make the approach a practical possibility. Bracket has developed an ePRO solution that for the first time puts patients at the center of the clinical trial, while providing first-rate services for the management of patient data.

Meeting the demands of next generation data capture

Bracket ePRO paves the way for a new wave of technology that can support today’s sponsors in exploring modern approaches to clinical trials like “bring your own device” (BYOD) models instead of provisioning devices. Unlike traditional ePRO solutions, Bracket ePRO has been built as an iPhone and Android app that can be used on any device, including patients’ personal devices for BYOD studies as well as provisioned devices. The solution has been built to enable sponsors to conduct virtual, “site-less” studies by keeping patients engaged in their own homes and giving them the ability to submit data via the app or collect it via integrations with wearables and sensors.

For sponsors, a single app could reduce the burden of managing clinical trials. Using this approach has commonly been found to reduce dropout rates by 50% or more, thereby decreasing the time and cost of patient recruitment. Further, by decreasing patient-related protocol deviations and improving diary completion rates, the quality of clinical data is enhanced.

As pressure grows on the industry to make patient-centricity more than just a buzzword, the capabilities of Bracket ePRO are beyond the delivery of traditional diaries and instruments—it’s helping make the patient-first approach a practical reality. Patients can join a study and manage all their requirements within one system, providing an improved experience that increases the likelihood of them wanting to participate in future studies/phases and the success of market launch.

Jeff Lee is President, eCOA and Patient Engagement, at Bracket. Jeff joined Bracket in 2017, following the acquisition of his company, mProve Health, which he founded 2010. As CEO of mProve Health, a leading provider mobile technologies for patient recruitment, engagement, and data collection in clinical research studies, Jeff grew the company globally. Today, its applications are used by 18 of the top 20 pharmaceutical companies, 15,000 clinical research sites in over 60 countries, and they are translated in over 50 languages. He can be reached at jeff.lee@bracketglobal.com