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Maintaining patient engagement and minimizing dropout rates in clinical trials is a persistent hurdle, with dropout rates soaring up to 30% in some studies. The National Institutes of Health underscores the importance of building trust, engaging communities, and ensuring clear and culturally sensitive communication at every stage, from pre-recruitment planning to post-study dissemination of results. Traditional methods often fall short in addressing the needs and concerns of participants, leading to disengagement and, ultimately, withdrawal from the trial. However, purpose-driven eClinical solutions like ENGAGE!, an integrated MyStudyManager™ Participant Portal and eConsent system, offer a more patient-centric approach that presents a promising avenue for recruiting and retaining patients for long-term engagement in clinical studies.
The Challenge: The Pitfalls of Traditional Patient Engagement Strategies
Traditional patient recruitment and retention strategies have relied heavily on manual processes, including paper consent forms, face-to-face meetings, and telephone follow-ups. While these methods have been the backbone of clinical trials for decades, they come with significant challenges. For one, they can be time-consuming and cumbersome for both site staff and participants. Additionally, these methods may not effectively address patient concerns or provide the support and information participants need throughout the trial process. This lack of engagement can lead to feelings of isolation or disconnection from the trial’s objectives, contributing to higher dropout rates.
The Solution: ENGAGE!
ENGAGE! is a digital platform that streamlines the recruitment and retention process. At its core are the MyStudyManager™ Participant Portal and eConsent solutions, designed to facilitate better interaction between sites and patients, and to simplify the consent process. This approach not only makes it easier for participants to understand the trial and their role within it but also empowers them with the tools and information they need to stay engaged throughout the study. Through the MyStudyManager™ Participant Portal, individuals can easily access trial-related information, receive updates, and communicate with the research team. This level of transparency and ongoing communication helps to build trust and rapport, which are crucial for maintaining participant engagement, particularly for the long-term.
The eConsent capability within the ENGAGE! software suite makes the consent process more accessible and understandable for participants. Leveraging the ability to remotely sign documents, ENGAGE! aids participants in fully comprehending the trial’s scope, procedures, and their rights before consenting. This electronic informed consent process is designed to meet regulatory requirements and increase participant confidence and commitment to the trial.
Key Features of ENGAGE!
ENGAGE! is an integrated eClinical suite tailored to streamline study activities and enhance participant interaction. The following key features contribute to a more efficient, transparent, and participant-centric clinical trial experience:
- Dashboard: A comprehensive dashboard for centralizing study-related activities and information.
- Virtual Visits: Enables remote interactions between site staff and participants.
- Compliance: Safeguards adherence to regulatory requirements and study protocols.
- Notifications: Provides real-time updates and reminders to participants.
- Document Management: Efficient handling and storage for study-related documents.
- ePROs: Supports electronic Patient-Reported Outcomes (ePROs) for enhanced data collection.
- Participant Stipends: Transparent tracking of stipend balances for participants.
- Study Schedules: Provides clear study timelines for participants.
- Mobile and desktop applications: Flexible and accessible across devices.
Participant Impact: Participant-centric Design
ENGAGE! simplifies access for participants through a Single Sign-On system, streamlining their ability to engage with study tasks and responsibilities. This easy accessibility not only strengthens participant engagement but also facilitates compliance with study protocols. The platform further ensures compliance through tailored notifications, keeping participants well-informed about study requirements and milestones. Additionally, by providing centralized site contact information, ENGAGE! offers participants a convenient and reliable point of contact, fostering effective communication throughout the study duration.
Participant Impact: Flexibility
Virtual Visits within the ENGAGE! system enables remote participation, effectively accommodating participants’ busy schedules and geographical constraints while ensuring their continued involvement in the study. Moreover, the integration of ePRO documents streamlines data collection and reporting processes. This facilitates an efficient and accurate recording of participant data. The platform’s eConsent system simplifies the consent process, providing participants with an accessible and understandable method to consent to study participation. These flexible options enhance the overall participant experience and contribute to higher engagement and retention rates in clinical trials.
Participant Impact: Experience
Through features like the Participant Satisfaction Survey, the ENGAGE! platform gathers valuable feedback, allowing for continuous improvement in the participant experience. By showcasing stipend balances, participants can be incentivized and motivated to remain actively involved in the study. Real-time notifications also play a pivotal role in keeping participants engaged and informed throughout the study duration, making sure they stay abreast of important updates and milestones. The inclusion of site branding in MyStudyManager™ additionally fosters trust and engagement by creating a familiar and personalized environment for participants, magnifying their sense of belonging and commitment to the study. Altogether, these elements contribute to a more positive and rewarding experience for participants in clinical trials.
Overall Impact: Site and Participant
By addressing critical areas such as retention, compliance, recruitment, and engagement, ENGAGE! provides a holistic approach to improving the clinical trial process. Customizable features and tools empower sites to better manage participant interactions, streamline consent procedures, and enhance overall study compliance. The platform’s integration with site-centric technology ensures compatibility with existing systems, like RealTime-CTMS, to optimize efficiency and minimize disruptions to site operations. This harmonious alignment between site needs and participant requirements ultimately fosters a more effective and sustainable clinical trial environment, benefiting all stakeholders.
Conclusion: Sustainable Long-Term Engagement
ENGAGE! (MyStudyManager™ Participant Portal + eConsent) offers a promising solution to the challenge of patient retention, improving recruitment, reducing dropout rates and fostering sustainable long-term engagement. By adopting a platform that addresses participant needs and concerns, ENGAGE! creates a more positive trial experience for both clinical research sites and participants. This approach not only benefits current studies by improving retention rates but also lays the groundwork for higher participant engagement in future trials. As clinical trials continue to evolve, embracing patient-centric solutions like ENGAGE! will be key to ensuring the success and sustainability of these important studies.
