For years, inconsistent patient engagement has been a leading challenge in clinical trials, requiring research coordinators and principal investigators to make a concerted effort to maintain study quality. Fortunately, the advent of Digital Health technologies — such as AI, big data, wearables and sensors — has allowed researchers to compile comprehensive data that can have a significant impact on the way trials are designed, ultimately leading to increased trial efficiency and improved enrolment. Additionally, these technologies have proven effective in enhancing patient management and engagement through home monitoring of chronic conditions after surgery, telemedicine assessment and app-based self-assessment tools. Together, Digital Health technologies can help increase the chances of a trial’s success — if implemented correctly.

Although the benefits of implementing Digital Health technologies into clinical trials are widely acknowledged, the integration of these technologies into trial designs can be burdensome to participating patients. Here, we discuss how adopting a unified patient experience can overcome the various challenges of integrating Digital Health into trials.

Benefits of Adopting a Unified Patient Experience

Despite advancements in Digital Health technologies, data continue to show there are dips in patient engagement. More than 30 percent of patients drop out of clinical trials before they ever become evaluable. [1] In addition, approximately 85 percent of all clinical trials fail to reach completion due to patient retention.[2]

This lack of efficiency may be a result of Digital Health technologies shifting much of the responsibility from the investigators to the patients. Clinical researchers designing trials tend to follow rigid protocols regardless of how many touchpoints they may require to ensure trial quality. Yet, trial success is largely dependent upon a patient’s active level of involvement, which can be inhibited when there are too many touchpoints.

For example, a trial participant may be tasked with entering their personal data — such as BMI recordings or daily activity reports — into multiple touchpoints such as wireless medical devices, mobile medical applications, Health IT, telemedicine, software as a medical device (SaMD), and more. However, having to remember so many touchpoints could place an unnecessary burden on the patient, reducing any incentive for entering the requisite data.

Streamlined Trial Design & Management

A unified patient experience, on the other hand, is a personalised and integrated solution that eliminates multiple touchpoints for patients and creates a platform where the patient can access all digital study activities through a one-touch access point. This platform would aggregate data from patient-reported outcomes, wearables, and remote assessments. Having this information housed in one system allows for investigators and site staff to easily collect and manage trial data.

Additionally, a personalised patient study experience should make it easy for patients to see what is relevant at their particular point in the study and aligned with their personal preferences for channels and content. The platform can provide services such as direct-to-patient medication shipment, setup of at-home assessments, device and sensor connection support, in-pharmacy assessments, and community setting assessments. Essentially, any study-related material could be found and managed through one login. One interface for all trial-related content can promote patient engagement by making the trial more efficient and convenient, simplifying the data collection process, and ultimately providing patients with a greater sense of privacy.

Improved Patient Engagement

An obstacle to patient engagement is that some trial participants may be required to periodically coordinate visits to clinical trial sites, which can be an enormous burden. In a recent survey carried out by the Centre for Information and Study on Clinical Research Participation, 24 percent of participants cited “too many study visits” as the reason for deciding not to participate in a clinical trial, while “travel burden” was cited by 79 percent of those surveyed on the barriers for clinical research participation [4].

Adoption of a one-touch access point could reduce the burden of multiple site visits by allowing patients to input all their daily entries from the comfort of their homes. Additionally, the same platform would have a feature that allows them to even arrange transportation for a physical visit, thereby further reducing patient responsibility.

Increased Patient Retention

Another benefit of a unified patient experience is that the consolidated platform can alert trial staff of problems that would have caused patient dropout or dismissal, thereby helping to improve patient retention. Here, when a patient is not compliant, the investigators can be notified, and a representative can immediately reach out to the patient to assess the situation. For example, if a patient is unable to record his or her blood pressure reading due to a malfunctioning or broken device, an investigator can respond immediately to assist. In turn, this can preserve data quality and keep the trial running smoothly, in addition to retaining patients in the study.  

Reduced Trial Costs

A unified patient experience may require a greater initial investment because of the development of the application and the need for a robust infrastructure. However, in time, it should more than pay for itself by leading to a reduced need for patient engagement incentives, such as monetary rewards. So, making it easier for patients to participate in studies can alleviate the financial burden on patients, sponsors and healthcare providers.

Additionally, since a unified patient experience would integrate wearable devices, mHealth and telemedicine, the number of visits necessary for a study would be significantly reduced, while still providing a holistic dataset from the patient, ultimately reducing the overall costs of the study.

A Unified Patient Experience Is the Future

Digital Health technologies are providing researchers with the ability to collect vast amounts of patient data, allowing researchers to uncover more meaningful insights. As sponsors continue to integrate these technologies into trial designs, it is essential to deliver a personalised and integrated solution that gives patients one entry point for all digital study activities – including ePRO questionnaires, device and sensor connection, e-visits, compliance monitoring and adherence reminders, and patient education and consent – to successfully optimise data collection, improve patient retention and engagement, and avoid costly delays.

To learn more about how adopting a unified patient experience can overcome the various challenges of integrating Digital Health into trials, contact our experts today.

Resources

  1. National Academy of Sciences. The Prevention and Treatment of Missing Data in Clinical Trials. Washington, D.C.: National Academies Press; 2010. Available at: www.nap.org.
  2. Forte Research. Retention in Clinical Trials – Keeping Patients on Protocols. 2015. https://forteresearch.com/news/infographic/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/
  3. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices -- Draft Guidance for Industry and Food and Drug Administration Staff. US Food and Drug Administration Oct 17, 2018.
  4. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf
  5. Pharmaceutical Market Europe - Oct 2018: Digital trials: A framework for success. 2018. http://digitaleditions.pmlive.com/html5/reader/production/default.aspx?pubname=&edid=826bd4de-3dfb-4f93-b724-057ada4a00d1&pnum=42