Sponsors, CROs, sites and clinical trial vendors work so very hard to make clinical trials successful. This arduous work includes protocol development, regulatory approvals, trial management, vendor selection, site selection, start-up, and effective participant recruitment just to get the study off the ground.
But one fact remains consistent today: Study participants, the most valuable part of the equation, are often given the least consideration throughout the trial execution process. This lack of participant engagement often leads to low retention, poor subject compliance with study requirements, and an overall poor experience for participants.
It is difficult to fully quantify what poor participant engagement adds up to in dollars and cents, but study delays due to high attrition, missed timelines and low efficacy scores as a result of non-compliance have significant financial ramifications that could alter the success of a Sponsor, study or even the approval of a drug.
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Because the impact is so significant, improving participant engagement at each site and industry-wide is essential to study retention and the success of future clinical trials. To work towards a long-term solution, the first step is understanding participant engagement and its benefits for research sites and the study participants.
What is Participant Engagement?
Participant engagement is keeping study participants involved throughout the clinical trial process. It includes all the methods that can be implemented to connect with study volunteers from the onset of recruitment processes through study participation and even after study completion. When site staff engage and work with their participants as early as possible in the trial process, it is likely to lead to faster enrollment, higher retention, and better compliance with study procedures. What this then means for sponsors, CROs and the industry as a whole is better quality data to support drug/device approvals.
RealTime’s MyStudyManager Portal: The Solution for Participant Engagement
The importance of participant engagement is evident and RealTime is taking the study participant experience to another level with a CTMS integrated participant portal, MyStudyManager, the first and only site-based participant portal! This new and exciting technology facilitates study activities while strengthening the relationship between both sites and participants. While RealTime inches closer to launching MyStudyManager, the real excitement comes from empowering participants to be a part of their research journey.
The Benefits of MyStudyManager for Participant Engagement
A high level of participant engagement will benefit sites, sponsors, and study participants in the following ways:
- Greater patient retention due to enhanced patient satisfaction and improved clinician-patient relationships leading to complete and quality data
- Improved compliance and data accuracy by staying connected with participants throughout the study process. Touch points can include reminders for subjects to complete study procedures while outside of the clinic setting, ways for subjects to confirm that procedures have been completed, and even ways to connect with subjects through virtual teleconferencing, text messages, push notifications, and more.
- Improved insight into participant satisfaction through post-visit surveys providing sites the opportunity to hear feedback and implement actions to meet participant needs
- Increased access to “hard-to-reach” and diverse communities based on distance and socio-economic barriers with the use of technology that supports decentralized clinical trials leading to accelerated and improved recruitment efforts
- Enhanced community ratings and perception of the research site and clinical trial participation
About the MyStudyManager Participant Portal
The MyStudyManager Participant Portal will offer many game-changing features including:
- Simple participant access to study schedules and other important activities
- Push notifications for important study events to keep participants on track
- Study calendar showing all upcoming visits
- Quick access to stipend information to track payments and card balances
- Integration of eCONSENT for in-house or remote consenting
- Site contact information for easy communication
- Video conferencing for remote Virtual Visits and Decentralized Clinical Trials
- ePRO and participant eSOURCE forms for diaries and other participant data collection
- MobileApp and desktop versions to suit participant preferences for access
- Post-visit satisfaction surveys for immediate participant feedback
- And so much more
The development of MyStudyManager is RealTime’s way of empowering participants to have a bigger voice in clinical research while improving study timelines, data quality, and the worldwide perception of clinical research through the eyes of volunteers. Sites now have tools to provide a world-class experience while gaining valuable insight through direct feedback from their participants. If we, as an industry, focus on creating the best participant experiences possible, clinical trials will have greater success rates with lower overall budgets while also strengthening the communities that we depend so heavily on. This is the beginning of a movement that we can all join together – a movement to reshape the participant experience and advance clinical research in our communities around the world.
To learn more about how you can join the movement and increase participant engagement as well as be the first to know about the release of MyStudyManager, follow us on LinkedIn and Facebook or fill out the form below.
