The industry metrics paint a troubling picture of the current state of clinical trials recruitment and retention. With 37% of study sites not meeting their enrollment targets and 80% of studies failing to meet theirs, the industry faces a dire need for more effective strategies (source: 2024 WCG Data Intelligence).

Part of the problem can be attributed to the limited participation of investigators in clinical research and significant issues related to site staffing. Moreover, recruitment and retention difficulties are recognized as significant detractors, closely tied to a site’s resourcing levels. This not only disrupts timelines but can also inflate the cost of clinical trials substantially.

Tackling the Site Identification and Feasibility Process

The process of site identification and feasibility is traditionally data-driven, relying heavily on existing relationships, in-house data, and historical experiences. Yet, a more nuanced approach is needed, incorporating a variety of data sources and reevaluating assumptions continually. For example, factors like the competitive landscape and protocol requirements must be considered, as they significantly impact a site’s recruitment and enrollment capabilities.

These activities are often treated as “one and done,” when, in reality, data from both internal and external sources constantly evolves. Feasibility, recruitment, and retention strategies must remain adaptable on an ongoing basis to maximize efficiency and study success.

The Gap in Trust and Communication

A significant gap exists between sites and sponsors regarding trust in feasibility results. Many sites believe sponsors trust their feasibility responses, whereas a vast majority of sponsors showcase skepticism. This disconnect underscores the necessity for a dynamic approach to site identification and recruitment planning, continuously adapting to changes and reevaluating initial assumptions based on real-world challenges and situations.

Rethinking Recruitment and Retention

Recruitment and retention should be viewed as a universal process with interconnected stages: identification, enrollment, retention, and documentation. Effective site selection, requires a deep understanding of a site’s capability to navigate through these stages, considering both internal contributions and the need for external referrals. Understanding the capacity of sites to manage external referrals and their geographical suitability for community outreach or provider networking is crucial.

Resetting Expectations and Approaches

The industry must acknowledge the active nature of clinical trials and the inevitable changes and disruptions that occur. Open and clear communication channels between sites and sponsors, mutual trust, and a shared focus on trial and participant priorities are essential for navigating these changes effectively. By fostering a collaborative environment free from blame shifting, the industry can adapt more effectively to challenges in recruitment and retention, ensuring trials are completed safely, efficiently, and with integrity.

In conclusion, addressing feasibility, recruitment, and retention challenges in clinical trials requires a multifaceted approach, emphasizing flexibility, collaboration, and continuous reevaluation. By bridging the gap between sites and sponsors and adopting more dynamic strategies, the industry can move towards more effective and efficient clinical trial processes and successful outcomes.

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About the Webinar

Join us as we explore the competitive landscape of clinical trials and how feasibility and participant recruitment and retention play a pivotal role in the success of a study.

In this webinar, our experts discuss:

• Developing site selection and recruitment strategies that are not one-and-done and are continuously modified and updated over the course of a clinical trial.
• Leveraging data and insights to have a better projection of site enrollment.
• Instituting the best ways to have high-impact improvements on site selection and recruitment

Discover More

WCG Total Feasibility Solutions

Optimize your study planning, site identification, and selection processes based on robust data and insights.

learn more

WCG Recruitment & Retention Solutions

Simplify your recruitment and retention strategies to devote your attention to the science, your sites, and your participants.

learn more

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The post Increase Your Site Enrollment Capacity appeared first on WCG.

The goal isn’t merely to enroll patients, it’s to successfully complete the study. To that end, we’re going to identify ways sponsors and CROs can help sites optimize enrollment capacity and improve overall study enrollment and retention.

A Flexible, Centralized Strategy

Begin with a centralized study enrollment strategy based on the protocol and targeted population. The centralized plan needs the agility to respond promptly to any site-specific issues and real-world complications.

Enrollment capacity involves all the resources that are needed to complete a trial, such as processes, team expertise, operational efficiency, and technological tools and, of course, time It takes just one flawed process, one obsolete technology, one understaffed area to stall enrollment.

Success requires having the right amount of the right resources in the right combination. Take chart review as an example. Seemingly straightforward, it nevertheless involves numerous elements which require careful attention. Consider:

• Record selection: How are records chosen? Is the EMR easily queried, enabling you to identify the right patient pool before reviewing individual records?
• Evaluation criteria: What are the assessment criteria? Are there elements that will call for physician discretion that shouldn’t be evaluated during chart review?
• Tracking: What are you using to track the chart review to avoid redundant work? Are you using a web portal, a spreadsheet, a sheet of paper or something else?
• Roles and responsibilities: Who conducts the review? Is it a full-time study coordinator or someone who can only dedicate a few minutes a day? Is there a consistent, repeatable process in place?
• Follow up: Once you have a pre-qualified subject, what happens next? Who takes that next action? Does the record get lost in a pile of others, or is there a system to reach out to potential participants?

Chart review is just one example. Most clinical trial processes have components that should be considered individually.

Beyond Inclusion/Exclusion Criteria: Participants as Individuals

Turning a patient into a participant involves much more than the inclusion/exclusion criteria. Understanding the real person behind the I/E criteria helps build vital relationships—relationships that support enrollment and retention. Being a study participant means the patient has volunteered their time and their body for the study. Will that person be willing to take part in a 24-month study? Are they willing to commit to regular visits?

It’s crucial to understand each participant’s motivations, not just at the beginning but throughout their journey through the study. What are their reasons for joining this study? What barriers might prevent them from participating or completing it?

By focusing on the unique needs and motivations of each participant, we can build trust and foster a more patient-centric study environment. This is especially true for unknown patients.

When we talk about a “known” patient, we’re talking about someone who already has a relationship with the site and/or the PI. There’s already a level of trust. But what about “unknown” patients—patients with no prior relationship? It’s important to understand them, build that trust to work with the clinical study site team, to motivate them not only to enroll, but also to stay in the study. It begins with that first encounter: That first impression – be it a phone call, a flyer, a website visit, an online ad – needs to be a positive one.

Diagnose the Problem, Then Act

The enrollment process will rarely go exactly as planned. That’s why it’s important to identify and address challenges early, tailoring interventions to each site’s needs and limitations

Begin by examining all existing processes. Pinpoint the bottlenecks. For example, if enrollment is lagging, the site may need additional support for recruitment and enrollment. In other cases, data entry and query resolution are falling behind, and the site needs support there.Providing data entry support, in turn, may create additional bandwidth to continue focusing on recruitment efforts.

Focus on implementing solutions that enhance the site’s capacity without compromising efficiency.

Here, it helps to think about the study lifecycle. Themore time you have, the more options you have. Efficiency tends to falter when timelines shorten. So, the more you can do in advance and plan and prepare, the better.

Ask yourself: Do the tools and resources we’re providing increase the site’s bandwidth, or do they add extra steps? You want to increase the site’s capacity, not its burden. For example, if a study requires a patient to be newly diagnosed, a retrospective chart review won’t prove very helpful.

Think about this: Are you truly enhancing the site’s capacity to enroll more patients? Or are you imposing additional processes that could slow enrollment and diminish the site’s interest in your study –or in ever working with you again?

Put it in Practice

Learning from patients and sites and sharing best practices among different sites can be valuable.

Study coordinator meetings provide the opportunity to elicit best practices that other sites can adopt. It’s also an opportunity to learn what isn’t working.

In trials involving multiple vendors, coordination and oversight are crucial. Aligning vendors’ efforts and ensuring a shared vision for recruitment success requires proactive management and collaboration.

Setting benchmarks and key performance indicators (KPIs) is essential for assessing recruitment success. However, use them as evaluation tools, not as penalties. Foster an environment where everyone feels safe to flag problems early, identify them and work towards a solution without fear of retribution. The process never stops: Evaluate. Plan. Deploy. Assess. Adjust. Repeat. (See figure 1.)

It bears repeating: Change is inevitable, and your plans will require adjustments. That’s why enhancing clinical trial enrollment requires a comprehensive and flexible approach that considers the site’s capacity, patient motivations, and ongoing adjustments based on real-world challenges.

When we all come together and take this approach of being flexible and adapting to change, we can solve most problems.

Your Enrollment Challenges. Our Expertise. Take charge of your study’s outcome.

Connect with our team of experts to discuss your studies and how we can quickly meet patient enrollment milestones.

The post To Optimize Enrollment, Stay Nimble and Listen to Sites and Patients appeared first on WCG.