In the journey to delivering innovative and potentially life-saving therapies to patients, conducting an efficient and high-quality clinical trial with your target patient population is critical. Yet despite the vital pursuit of getting these drugs to patients as soon as possible, more than 80% of clinical trials fail to enroll on time1, leaving sponsors that may have already spent the majority of their recruitment budgets scrambling to meet enrollment goals while maintaining target timelines. When these factors compound, a trial will enter “rescue” territory.
Though a rescue study situation may seem dire, there are ample tactics that can help get a trial back on track. Furthermore, with the right feasibility, planning, recruitment, and data analysis strategies, your team can avoid rescue situations altogether. The key is implementing a robust, patient-centric approach that provides patient support across every stage of the funnel and prioritizes proactive and collaborative solutions between sponsors, sites, and recruitment partners.
With drugs that have widespread demand, i.e., GLP-1 obesity treatments, a digital marketing patient recruitment strategy might be sufficient to meet your enrollment goals. However, with more complex indications and therapeutic areas, a one-size-fits-all patient recruitment plan will likely fall short, failing to reach or engage your target patient population. Furthermore, if sites under-enroll, recruitment partners face the challenge of meeting targets with limited time and budget.
If a drug sponsor spends 95% of their recruitment budget with a vendor that cannot meet their enrollment goals, that budget is tapped, the trial is behind, and sponsors are forced to fix things as quickly and cost-effectively as possible. Without proper planning, a negligent recruitment strategy could lead to increased costs, enrollment delays, regulatory non-compliance, and most devastatingly, trial failure.
To design a patient recruitment protocol that reaches your target patients and attracts their attention, commit to robust feasibility studies and front-end planning. Start by conducting research to identify who your target patients are, where they are located, and which sites are best equipped to execute your trial. Even if a site is high performing, it is critical to assess whether it is in an area that is accessible to and/or populated by patients within your target demographic(s). With this data at hand, you can pinpoint optimal recruitment sites for your target patient population.
At CSSi, we work with sponsors to conduct their feasibility studies and assess site performance data. Our approach to patient recruitment leverages both digital and traditional media, community engagement, boots-on-the-ground recruitment, and physician referral. With a full arsenal of recruitment methods at hand, our end-to-end support provides trials with a differentiated recruitment strategy and prioritizes patient and site support every step of the way.
In the earliest stages of a trial, sites are often so overloaded with tasks that administrative follow-up with prospective patients might fall by the wayside. Thus, patients interested in participating may not receive the necessary follow-up calls and screenings to qualify them for the trial. If they do get through the requisite pre- and secondary screenings to qualify them for a trial, many fail to show up for all necessary appointments.
Beyond that, even if a patient does participate in their first few visits, you are still at risk of losing their participation. Consider once more the GLP-1 trial scenario. If a patient is enrolled in a GLP-1 trial to treat obesity and they rapidly lose weight before the trial is complete, they could easily drop out and stop participating. Conversely, if they are 30 days into their trial and still not seeing results, they are also likely to drop out. The challenge is identifying ways to keep these patients engaged so that they are retained throughout the duration of the trial. Failing to keep a patient enrolled in a trial and replacing them when they drop out is significantly more expensive than simply investing in retention from the start.
Prioritizing the patient experience at every stage of a clinical trial is critical to retention. CSSi’s local enrollment specialists are all former site coordinators and/or physicians that have experience with clinical trial research and an understanding of the support needed by both patients and sites. Our enrollment specialists are deployed to optimize the enrollment process for patients in the middle of the enrollment funnel, i.e., patients who have completed their pre-screening and are pre-qualified to participate. At this stage, enrollment specialists conduct a secondary screening process to determine whether patients are highly qualified and confirm their findings via medical record review. Without this burden, site teams can focus on the daily activities that contribute to a positive patient experience.
Once a patient has enrolled in a trial, all stakeholders must consider how to ensure they continue showing up for their appointments. This includes facilitating travel (via concierge or reimbursement), sending regular reminders, and generally making the process as easy and straight-forward as possible. To ensure continued patient participation and engagement, conduct surveys to gather patient feedback and share regular trial updates to foster a sense of community. A trial team should commit to providing patients with support, education, and opportunities for feedback across all stages of a trial.
In many situations, trial stakeholders do not have access to real-time, cohesive data that allows them to make decisions proactively rather than reactively. Without a reliable dashboard that tracks the leading indicators for a trial entering the rescue or failure zone, the alarm won’t sound and a trial may be too far gone by the time rescue plans are implemented. This is only perpetuated by communication failures amongst the different vendors across a trial’s ecosystem. As a result, the onus for data collection, analysis, and interpretation falls to the sponsor or CRO, who must collate said data, identify leading indicators, and provide trial status reports as efficiently as possible.
Often, by the time that data is gathered and analyzed, it is already too old to be relevant. For example, if a trial is using 30 different sites and all 30 sites are returning different data sets to sponsors, this creates 30 different opportunities for delays. From there, the data has to be interpreted across a number of stakeholders, including recruitment vendors and study managers, which requires meetings and could further delay the process of designing a mitigation plan. By the time a trial team reacts to concerning data trends, they are already far behind the ball, and a vicious cycle ensues.
CSSi’s proprietary tech stack includes a centralized dashboard with leading indicator data on myclinicaltrial.com, which offers portals for sites and sponsors. The sponsor/CRO dashboard provides high-level, predictive analysis of the patient funnel, ROI, patient demographics, and referral status. It also sends alerts to a sponsor, and CSSi, when a site is not processing patients rapidly enough to meet timeline goals. In response, CSSi engages directly with underperforming sites to quickly diagnose and address any barriers limiting the site team’s ability to support patients.
This centralized dashboard also includes functionality that allows site personnel to see all pertinent information about a patient, update patient statuses, and send patients texts and emails. The platform has working application programming interfaces (APIs), or is in the midst of developing them, across all of the major clinical trial management systems (CTMS) to provide real-time status updates and data for review.
Though rescue study situations are incredibly common, there are solutions at the industry’s disposal to avoid them altogether. By conducting feasibility and planning procedures and identifying the right recruitment partnerships, sponsors can successfully enroll their target patient population on time. As real-time data guides site teams, trial stakeholders can make strategic pivots along the way based on key performance indicators. Activate these techniques to ensure timely enrollment, patient retention, and rapid delivery of your drug to those in need.
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