Patient centricity and engagement demands that associated technology is developed in a way that research activities are aligned with the patient’s lifestyle. To do this effectively, we must understand the evolving needs of patients. At ICON, we regularly conduct patient surveys and collaborate with patient advocacy groups to gain insights on the patient care profile to encourage broader and more engaged participation. Based on results from a 2021 survey around decentralised clinical trial aspects, patients favour optionality – they want options that empower them to make decisions about how and where they interact with their physician, and they want flexibility and convenience. Patients indicated strong preferences for visits that took place both in-home and at sites (hybrid studies), and the majority were open to fully virtual visits and expressed a strong preference for technology.
With these and other patient insights, we are able to better design and deliver truly patient-centric trials. Patient centricity is more than a buzzword – it is an actionable methodology for tackling some of the challenges within clinical research and driving diversity, minimising burden and supporting engagement and compliance for participation of care within clinical trials.
The ICON Digital Platform is an end-to-end solutions designed to engage patients throughout their clinical trial journey. The novel ways that we have incorporated patient centricity into the development of this platform and the patient-facing mobile app supports patient ongoing interaction with their care plan and real-time oversight for sponsors.
Patient engagement throughout the clinical trial journey
The mobile app was the priority from the start and a corner stone in the development of the ICON Digital Platform. It provides an easily accessible, user friendly mode for patients to understand and follow their clinical trial journey with a higher degree of flexibility. As a trial is introduced to a patient, they can select different options to interact, engage and obtain support within the app. Patient can select different options for example, during the consenting process patients can access short videos to gain a better understanding of the trial requirements through the app and then the patient can review and eConsent directly in the app with their physician through telehealth (if country regulations allow) or they can choose to print and sign at the site.
In developing the platform, we started with the patient and assessed all services and roles that engaged with patients. With specialised operational expertise, we took a purposeful approach to patient participation and engagement within the platform to enables patient, site and sponsor oversight within the platform.
Guiding and supporting patients
The patient journey begins with a guided set-up process sent via email from their physician, the investigator, inviting them to the app. The mobile app presents patients with a visual of their trial pathway and all the information they need in the process is pre-loaded for easy access.
Next steps, site visits and other tasks are clearly outlined in the app with customisable notifications, supporting patients to remain compliant and minimising protocol deviation. The app also prompts patients to submit necessary information ahead of their site visits to streamline visits and potentially reduce burden for site staff.
Home health nurses can also use the app to input data during in-home visits, providing transparency to physicians and an accessible point of interaction for patient care plans.
Reducing burden in use and connectivity
The capability to use BYOD has been standard in ePRO for some time but the mobile app’s integration across all services for patients is a significant shift. Patients benefit from using their own device and reducing the burden of managing additional hardware. Ease of use positively impacts engagement and retention and reduces some of the barriers to trial participation associated with improving equity and diversity in clinical trials.
The app’s offline capability is an important function that aids in compliance, especially for primary and secondary endpoint data capture. It means patients don’t have to worry about maintaining connectivity every second of the day. The app will automatically sync when it reconnects to keep data up to date. This can be helpful for in-home services, where the home health nurses can focus on the patient during visits rather than worrying about wi-fi connection for upload of data.
Empowering patients with information
Patient insight also indicates patients’ desire for information at all stages of a clinical trial. The app serves as a one-stop-shop for patient information and can be loaded with relevant patient educational videos and other materials such as those provided by our FIRECREST content. With all this available at their fingertips, patients can feel more knowledgeable and confident in their clinical trial journey.
Customised concierge support
The Digital Platform’s broad integration capability supports a wide range of patient services, including eCOA, televisits, digital health technologies. We recognise that patient level support requirements vary across traditional, hybrid and decentralised trials, and designed the platform with this scalable capacity in mind. Our Concierge Services delivered by clinical, technical and logistical specialists interact through multiple channels including email, chat and phone to provide support and troubleshoot challenges for the patient.
Decentralised clinical trials offer unique opportunities to improve equity, diversity and inclusion in clinical trials. As sponsors increasingly adopt decentralised methods and adapt to operationalising them, the digital platform offers support infrastructure and global scalability.
Flexibility of design in the ICON Digital Platform facilitates the logistics and integration of data while delivering a positive clinical trial experience for the patient. The seamless interoperability of the various functions reduces deployment and study start-up timelines and streamlines key operational systems for harmonised data. The platform’s customisable design supports all study designs, from traditional to fully decentralised, and for any therapeutic area.
Connecting patients and trials
We run clinical trials to develop new therapies to benefit patients’ lives, and those trials rely on patients to participate in the process. Patients are the heart and reason for clinical research, which is why it’s important for our industry to continue efforts to improve patient options for participation.
True patient centricity needs to be built into the trial design and into the supporting digital platform, starting with patient journeys instead of trying to fit the patient into traditional models. Providing options and information on their own device through a mobile app reduces patient burden and delivers a more positive patient experience, which needs to be a priority as we continue to transform the clinical trial landscape and increase access to clinical trials.
By Carrye Nibblelink, Executive Director, Decentralised Clinical Trial Solutions
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