You will have all read, with great excitement, the articles about the mobile and decentralized clinical study that PRA and Janssen have partnered on – CHIEF-HF. This is the first ever interventional study being conducted in a completely decentralized manner and it wouldn’t be possible without mobile health technology.
With the challenges PRA, our Clients, Investigators, sites and patients continue to face because of COVID-19, the case for integrating mobile health technologies into clinical trials grows stronger. The CHIEF-HF study has not missed a beat since the COVID-19 pandemic started – it was our only PRA study that didn’t need to change anything it was doing.
In response to COVID-19, PRA was able to roll out two very effective solutions using our MHP. The first is a mobile app to provide to patients already on a clinical trial to enable continuity of their care in a decentralized setting. The second is for companies to provide to their employees or to anyone who may be experiencing COVID-19 symptoms and needs to track their progress and treatments. When COVID-19 hit, PRA was ready to immediately modify the existing capabilities and provide our world with these quick options and help flatten the curve.
PRA’s mobile app can:
- Arrange and track virtual meeting times between sites and patients
- Gain consent to ship IP to the home
- Alert sites to basic symptoms through a simple questionnaire
- Conduct a virtual visit in a CFR-11 compliant system
- Assess the COVID-19 impact at the patient level
- Ensure patient safety and study continuity
- Mitigate protocol deviations
- Prompt investigator to collect symptom reporting when needed
PRA’s Mobile Health Platform
PRA’s complete Mobile Health Platform (MHP) provides a comprehensive array of products that enable mobile technology integration into our clinical studies. MHP, formerly known as Clinical6 (C6), joined the PRA family in 2017. The technology seamlessly integrates into the mobile lifestyles of patients and streamlines experiences for sites and other clinical trial stakeholders. As you can see with the CHIEF-HF example, MHP is an end-to-end solution that empowers clinical trial participants to enroll and engage patients in a clinical trial from their mobile devices and in the privacy of their own home, when needed.
The full MHP solution first and foremost surrounds the patient and creates an ecosystem of patient care.
Why use MHP?
The investment and introduction in technology is substantial, but there are significant returns on this investment and benefits for all stakeholders.
- Decrease the barriers to being able to participate in a clinical trial because location is longer the rate limiter; clinical research can become a care option for more patients, regardless of where they are located
- Increase diversity and inclusivity of patients
- Reduce the burden of participation and thus patients will be less likely to drop
- Increase patient compliance by utilizing push notifications (SMS, email, in app alerts) for protocol assessments and drug diaries
- Fewer time consuming on-site visits by integrating wearable devices (e.g. glucometer readings, temperature, weight, blood pressure, etc.), and video telephony calls
- Decrease the resource burden by managing their study centrally with one platform to login to and through the use of dashboards that provides them overall study metrics in real-time
- Reduce their effort in following up to ensure protocol deviations and violations are minimized
- Able to intervene quicker and support patients in real time with the ability to monitor and collect symptom reporting to assess potential AE/SAEs with real-time notifications to sites
- Reduce time consuming data entry with direct to EDC integrations, thus reducing queries because of the accuracy of data
- Reduced overall timelines translates to reduced cost:
- When more patients have access to the trial, enrollment is increased
- Site activation can be quicker when they are setup with easy to use dashboards and connectivity to the patient
- Improved patient compliance and retention translates to reduced cost:
- Significant reduction in overall site management and data management time
- Improved sponsor oversight and inspection readiness:
- Real-time tracking and data access, especially to electronic Clinical Outcome Assessments (eCOAs) and eDiaries
 Patient non-compliance with paper diaries, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC111114/
A MHP technology solution may not be the solution for every single trial, but when combined with data and the patient experience, there may be opportunities to add the MHP to traditional studies or a hybrid of traditional and off-site activities. The true benefit comes from a seamless coordination between study operations and implementation of the right technology to solve the right problems. MHP is a valuable tool within the full solution, and as an embedded part of the PRA family, we can strategically inject technology to make study management more efficient while coordinating with the world class experiences that our sponsors have come to know and value. Each sponsor will have their own definition of risk regarding implementing technology within a study; our role is to ensure we offer a fit-for-purpose approach, combining operational and technological solutions to meet their needs and ensure success.
Things to Know about eConsent
The entire MHP platform is important, but eConsent has some special considerations and things you should know. eConsent refers to the process of informing patients of their rights to participate in a study through electronic means. An electronic informed consent provides the same information as a traditional informed consent but in an electronic format (mobile or web based).
The legislative landscape with respect to mobile technology and eConsent is evolving rapidly and PRA’s experience continues to build.
Benefits of eConsent
- Enhanced patient comprehension
- Reduced administrative burden & increased quality
- When there is a protocol amendment, the new ICF is uploaded and compliance to consenting is easily viewable by the sponsor
- Assurance that all patients have been consented with the right consent
eSignature and Consent Management
PRA’s MHP uses Adobe Sign for electronic signature collection (eSignature) through our interactive digital solution available on any internet-enabled device. The eSignature process is almost a mirror image of the traditional paper based consent signature process, yet the ICF is presented to the patient (caregiver, guardian, etc.) via a web-enabled device and the signature and date are obtained electronically through the use of eSignature. eSignature does not replace the consenting process or need for an Investigator/designated qualified site personnel to adhere to ICH/GCP principles.
Print to Sign can be used in countries or at sites where eConsent is not permitted/liked. With the click of a mouse, study staff can download and print the entire package of consent forms to be presented to the participant. MHP also provides the option for uploading the signed consent forms (scanned version) back into the application for easy record keeping.
Whether pure eSignature, download for wet ink signature and/or retention of wet-ink at site for source data verification, the MHP remains as the system of record, maintaining prior versions for audit and availability for signature/download of the only current versions, ensuring that the EC/IRB approved ICF is always signed and tracked.
In this type of model we utilize additional tools within the consenting process to help provide participants with the information they need to make a fully informed decision on whether or not to participate in the study. The multimedia model has the following objectives.
- Empowers patients to make informed decisions using interactive components, e.g. pictures and diagrams, consent synopsis, comprehension checks, knowledge review, video/audio, etc.
- Enables improved data quality and clinical trial efficiency through insight into the patient experience and a fully electronic system; a more informed patient will increase protocol compliance and retention
- Pictures and diagrams: Studies have shown that visual aids can help explain and reinforce key study components or complex topics, e.g. risk percentages, explanation of a serious adverse event (SAE), specific study procedures, and the study schedule
Deployment and Maintenance
Ownership of the final MHP deliverable will include all content, functionality and user acceptance testing required for MHP go-live. Teams must collaborate to ensure additional changes as a result of MHP design, protocol amendments etc. are incorporated in real time, whilst in line with country regulations.