Have you ever shopped online and received a follow-up email from the store, not just thanking you for your purchase but also recommending other products that perfectly match your past orders? Or have you visited a local bakery where the staff remembers your favorite pastry and prepares it for you as soon as you walk in? They often strive to create a more engaging and convenient experience by anticipating your needs and preferences. In a world where interactions are often automated and impersonal, these personalized experiences enhance the human connection and make all the difference, helping us feel seen and appreciated. Imagine applying this level of personalization to diverse recruitment for clinical trials. It could significantly boost the participation and retention of diverse populations, making participants feel valued and engaged.
When thinking about operationalizing the inclusion of diverse people from different backgrounds, cultures, races, ethnicities, ages, genders, sexual orientations and economic circumstances in clinical research, we face numerous challenges. Unlike customer loyalty programs at places like Starbucks, clinical trials are complex and carry historical and cultural weight. Also, unlike these locations, clinical trial sites are often not part of the same organization. And finally, inviting people who historically have not participated in research may involve connecting with trusted providers and community leaders, as they are the ones who can best communicate a clinical trial’s value proposition.
The importance of integrating participant experience into site operations cannot be overstated. Providing a high-touch experience for everyone is crucial. Improving participant experience aligns with the FDA’s priorities to ensure diverse participation in clinical trials. According to FDA Commissioner Robert M. Califf, “Participants in clinical trials should be representative of the patients who will use the medical products.”
The FDA recently released new details in its draft guidance for industry, titled Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. The draft guideline requires sponsors to prioritize effective community engagement, participant awareness, cultural competency, reduced participant burden, improved access and monitoring and managing site operations. This aligns with the goal of enhancing participant experience to achieve better diverse representation in clinical research.
XTALKS CLINICAL EDGE: Issue 3 — Interview with Studypages
Xtalks Clinical Edge is a magazine for clinical research professionals and all who want to be informed about the latest trends and happenings in clinical trials. This magazine immerses you in a world where industry leaders, patient advocates and top researchers converge to provide the most insightful perspectives on clinical trials.
What Do Sites Need?
Anyone who has worked in trials will understand that providing personalized experiences to a diverse range of people requires cultural competence, multilingual skills and utilizing a range of communication methods tailored to each participant’s preferences is challenging and requires a lot of time and effort. Keeping track of recruitment initiatives and making sure that no people fall through the cracks with proper handoffs becomes a huge operational challenge. With growing demands for more diverse recruitment and regulatory emphasis, we may need to consider if we are placing an excessive burden on already-strained sites. Given these challenges, how can we empower sites to scale a delightful participant experience to diverse demographics?
In a survey conducted by the Society for Clinical Research Sites (SCRS) in 2023, sites ranked trial-specific community engagement support as the number one ask to industry partners besides budget. Second was technology to enable diverse enrollment. Herein lies the key to empowering sites to enroll and retain diverse participants, track progress and implement adjustments.
Going back to our examples, how do companies deliver such personalized experiences? How can we learn from and implement them in clinical research? Businesses often use CRM software, which is short for Customer Relationship Management. This technology helps companies of all sizes manage and support customer relationships. CRM technology enables organizations to store, track, and analyze customer and prospect information in one central location. It gives companies a comprehensive view of customers and prospects, which teams across the company can easily share and analyze in real-time. The clinical research industry will greatly benefit from adopting similar personalized approaches.
Managing Participant Relationships with Technology
Similar to how CRM systems assist businesses in monitoring the customer journey and customizing interactions, study teams can use technology to establish connections with study participants. By tracking each participant’s journey, providing relevant information at each interaction and responding promptly to questions, teams can effectively connect with participants at a human level. Utilizing tailored interactions and consistent follow-up with relevant messages will ensure that participants remain well-informed and engaged. This allows study teams to establish trust and encourage long-term commitment and engagement.
Let’s imagine a scenario involving a trial for a new medication. In this trial, CRM-based technology is used to address challenges in recruiting and retaining diverse participants. At a community event, a multilingual participant website is shared by a site to raise awareness and generate interest in participation. Following the event, interested participants are contacted in their preferred language and communication method to assess their eligibility. They receive personalized welcome messages and regular updates tailored to their preferences to keep them informed and engaged. The team works remotely and utilizes secure web chat, web-based calling and automated notifications to follow up with participants. They also effectively collaborate using the same platform. Sponsors are provided with detailed analytics on participant-site interactions and can make operational adjustments in real-time. As a result, the trial successfully recruits a diverse participant cohort representing various backgrounds. This scenario demonstrates how a CRM-based technology approach can enhance participant experience by personalizing communication and streamlining site operations to foster trust, promote diversity and maintain participant engagement.
Delivering on the Promise of the Digital Transformation of Clinical Research
Technology plays a vital role in supporting diverse enrollment and retention in clinical research. While significant progress has been made in digitally transforming the research industry, especially in remote study participation, there is still a need for better community outreach and communication resources at research sites to attract a diverse pool of participants.
The key challenge lies not only in adding more tools but also in integrating these solutions in a comprehensive and versatile manner. Each tool should have a backup method, and every participant-site interaction should be tracked to continuously learn and improve the trial delivery process until it operates flawlessly. A robust process will help minimize the risk of losing valuable participants and therefore drive diverse enrollment.
Can Clinical Research Compete with a Consumer Brand, Given Its Complexity?
With the right technology, we believe it certainly can. Our Studypages platform unifies technology with human interactions to transform patient recruitment and retention. It brings together the community, sites and sponsors. It helps deliver sites a delightful participant experience from initial contact through study completion. Our platform achieves these by providing sites with workspaces to track and manage participants, as well as integrated tools for outreach, communication and scheduling. It also provides Sponsors with detailed analytics on participant-site interactions and ways to monitor and implement operational changes. And provides the community with resources to learn more about research opportunities and ways to get involved. With its all-in-one integrated platform, Studypages lets clinical operations teams work smarter so they can spend more time supporting participants and sites to accelerate the development of new therapies.
Incorporating participant relationship management into clinical trial operations is a transformative approach. By personalizing interactions and effectively tracking and communicating with participants, sites can build trust, enhance engagement and foster commitment, leading to more efficient trials and more equitable healthcare outcomes.
Studypages by Yuzu Labs PBC offers a unified platform for managing the participant experience and clinical operations. It enables sponsors to deliver a scalable and personalized participant journey from initial contact to trial completion. The platform features intelligent workspaces for sites and integrates various tools for outreach, tracking, communication, scheduling and data collection. Sponsors can access real-time data on participant-site interactions to identify issues early and make rapid adjustments. Studypages aims to delight sites and participants while eliminating the use of spreadsheets and email to manage outreach, enrollment and retention.
Join or login to leave a comment
JOIN LOGIN