Enhancing clinical trial engagement: a deepdive with insights from James Riddle of Medidata

2024-03-01
临床研究
James Riddle, senior vice president of global review services operations at Advarra, shares valuable insights into the company's vision and its impact on the healthcare industry. Through his perspectives, we gain a deeper understanding of the importance of engagement in clinical trials and the strategies employed to optimize participant involvement. Here are some illuminating insights from a conversation he had with Liza Laws, senior editor of Outsourcing Pharma and Biopharma Reporter had during the 2024 SCOPE summit in February 2024.
Riddle says Medidata is addressing the issue of site burden with single sign-on solution capabilities. He said: “Our approach is to authenticate users with their existing credentials, eliminating the need for separate sets of credentials for each platform. This not only simplifies access but also enhances security.”
The company is also ensuring it is keeping abreast of fostering participant engagement and retention: “To ensure the success of clinical trials, we must focus on engaging participants throughout the entire study duration. It's not just about enrolling them; it's about keeping them engaged and informed. This requires a robust retention strategy that goes beyond recruitment efforts.
“At the heart of every clinical trial is the human element. Participants remember their interactions with research coordinators more than anything else. Whether in-person or through telepresence, positive and supportive interactions are key to maintaining engagement.”
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Meaningful data
He told OSP that engaged participants contribute to high-quality, meaningful data and that it's not enough to have retention materials.
He added: “We must monitor how participants engage with these materials to gauge our success. This data integrity is crucial for regulatory approval and ultimately, improving patient outcomes.
“Engaging participants in clinical trials isn't just about collecting data; it's about building trust and respect. When participants feel valued and respected, they're more likely to stay committed to the study, leading to better outcomes for all stakeholders involved.
“As technology advances, we must adapt our approaches to participant interaction. While digital tools offer convenience, human interaction remains paramount. Combining technology with personalized engagement can enhance the participant experience.”
Riddle says it is time to start completely rethinking trial engagement strategies. He said: “We need to shift our focus from enrollment numbers to engagement quality. An engaged participant contributes more meaningfully to the study and is more likely to see it through to completion. This requires a holistic approach to trial engagement strategies.”
Deeply human-centric
Riddle's insights shed light on the evolving landscape of clinical trials and the pivotal role of participant engagement. By prioritizing meaningful interactions and fostering trust, he says Medidata and other innovators in the field are shaping a future where healthcare research is not only efficient but also deeply human-centric. As the complexities of medical innovation continue to be navigated, the lessons gleaned from Riddle's expertise serve as guiding beacons toward a brighter, more engaged future in healthcare.
On leveraging technology for enhanced engagement, he said: “Technology offers incredible opportunities for enhancing participant engagement. Whether through telepresence, remote sensors, or interactive platforms, we have the tools to create meaningful connections with participants. It's about leveraging these technologies to make the trial experience more personalized and accessible.”
Measuring success through engagement tracking, on this he said: “Engagement isn't just about sending out materials; it's about tracking how participants interact with them. Utilizing platforms like Longboat allows us to monitor engagement metrics and adjust our strategies accordingly. By measuring success, we can continuously improve the participant experience.”
Empowering participants as advocates is important to Riddle, he said: “Participants aren't just passive subjects; they're advocates for medical progress. By empowering them with knowledge and engaging them in meaningful dialogue, we can foster a community of informed participants who spread the message of clinical trial importance.”
When we spoke about shifting the focus to participant-centric trials, Riddle's main point was to stop focusing on getting patients in and try and think about how to keep them engaged. He said: “The time has come to shift our focus from enrollment numbers to participant-centric trial design. We need to prioritize retention and engagement strategies that ensure participants feel valued and respected throughout the trial process. Only then can we truly achieve meaningful results.”
Compensation - not to be primary motivator
Embracing change for better healthcare, Riddle said: “To truly enact change in the healthcare industry, we must be willing to think differently and act accordingly. COVID-19 presented us with opportunities to innovate, and now it's up to us to continue embracing those changes for the betterment of clinical trials and patient care.”
The importance of engagement strategy can include sponsors shortening trial times. Riddle noted that investing time upfront in developing a comprehensive engagement strategy can significantly impact the success of a clinical trial. He added: “By mapping out engagement points, creating engaging content, and ensuring readiness, sponsors can shorten trial timelines and improve overall efficiency.”
He said while compensation in trials is important, it shouldn’t be the primary motivator for participation and that those taking part should be motivated by a sense of purpose and understanding the significance of their contribution. He says this can be achieved by providing content and updates on trial progress can help maintain patient participant engagement.
Standardizing engagement content across sites was also touched upon during the discussion. He said: “Ensuring consistency in engagement content across sites is crucial for providing all participants with the same level of information and support. By empowering investigators with approved engagement materials, sponsors can enhance the participant experience and improve retention rates.”
Complexities of clinical research
Riddle's insights highlight the critical role of participant engagement in clinical trials. By prioritizing engagement strategies, rethinking incentives, and standardizing content delivery, sponsors can create a more supportive and informative environment for trial participants.
He said: “As the industry continues to navigate the complexities of clinical research, let us heed Riddle's advice and strive for a future where every participant feels valued, informed, and empowered to contribute to medical progress.”
Riddle paints a compelling picture of the future of clinical trials—one where participant engagement takes center stage. By prioritizing meaningful interactions, leveraging technology, and empowering participants, he said the industry can create a new paradigm in medical research—one that values the contributions of every individual involved.
To conclude he said: “As we navigate the complexities of healthcare, let us heed this call to action and strive for a future where clinical trials are not only efficient but also deeply human-centric, empowering participants to be advocates for progress and change.
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