As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and most importantly, for patients in need of life-changing therapies. Ironically, on examination, the causes for under-enrollment and poor retention often come down to patient burden: Every patient’s circumstances are unique and meeting patients where they are is key. A Recruitment Lead can help.
Among a cascade of problems, recruitment challenges are costly.
A recent report from the Tufts Center for the Study of Drug Development suggests that around 80% of clinical trials face delays, and subject recruitment is a major contributing factor. The financial impact can be enormous.
- As the study timeline expands, so does the study budget.
When sites need to be operational for prolonged periods, expenses related to site maintenance, staffing, and logistics grow. Site contract amendments may be warranted. Monitoring may be stretched over longer periods, which increases costs associated with monitoring visits, data management, and quality control. Extending study-specific staff may actually lead to inefficiencies and potentially idle resources.
- Investigational products (IP) have a distinct shelf life.
Longer timelines for product manufacturing and distribution can be a critical burden for sponsors. When trials are delayed or extended, sites may require additional shipments of fresh IP—and unused expired product may need to be collected and returned. All that can be expensive.
- Adjusting protocols to attract recruits has downstream impact.
Often, as sponsors analyze slower than expected enrollment, they decide a protocol amendment may help. Minimizing secondary endpoints, revisiting inclusion/exclusion criteria, and adjusting the schedule of events can all help eliminate barriers to enrollment and retention. Yet, these steps involve many players, added administrative expenses and regulatory fees, and additional time training the study team and site staff. The sooner these changes are made, the less disruptive they are to the study. - Delayed market entry leads to missed revenue.
Quite simply, sponsors can’t reap the benefit of a new product if it is not in market. Moreover, during a delay, a competing therapy could seize market share and gain the upper hand.
Ultimately, subjects pay the highest price. Even though an investigational product is not a guaranteed solution, it offers hope. And sometimes, even if the results aren’t optimal, within the trial patients have an option for an alternative or added treatment. If they haven’t been recruited, that can never happen.
Adding a Recruitment Lead to the trial team can address many underlying issues.
A Recruitment Lead is an expert in clinical trial patient recruitment strategies. They understand the challenges and nuances involved in identifying, enrolling, and retaining suitable participants—and they have an arsenal of tactics with which to surmount barriers. Working closely with clinical trial sites, the Recruitment Lead can help identify target patient populations, implement innovative outreach strategies, and address potential barriers to enrollment.
- Facilitate communication and coordination.
Post activation, Recruitment Leads meet site staff regularly to ensure they have the necessary resources and support for effective patient recruitment. Meetings may be weekly, bi-weekly, or monthly depending on the stage and needs of the trial.
- Develop a comprehensive recruitment plan tailored to the specific trial requirements. Examining detailed recruitment data, the Lead will consider how many subjects are in screening, how many have failed, how many have enrolled, and what the pipeline looks like—then consider what levers are available to shift the metrics. Scrutinizing these numbers weekly also can inspire the research coordinator to proactively and preemptively plan for recruitment.
- Harness a range of tools and technologies to amplify recruitment efforts.
While there are many ways to reach potential trial subjects—print marketing, social media campaigns, patient databases—the most effective ones vary depending on the patient profile and geography. The Lead will research this and help deploy IRB-approved recruitment tools, managing ad budgets and other recruitment-related expenses. They may even identify recruitment monies that sites aren’t aware of.
- Help allocate and optimize operational resources.
Vendor logistics also fall under the Recruitment Lead’s purview. They know what supplies are needed, when they expire, and whether the data are entered correctly.
Overall, the Recruitment Lead is a collaborator with the site study team. Together they can probe why a patient declined the study, and through that discover where the patient burden lies and how to mitigate it. These steps, in turn, can help bolster recruitment and secure retention.
Is it time to rethink support for patient recruitment?
Covid demonstrated the need for expeditious enrollment. What if all diseases were viewed in this light? Speeding enrollment can benefit any trial and any sponsor. When trials are make-or-break for the sponsor, or offer critical hope for patients in need, the imperative to accelerate the timeline is even stronger. A Recruitment Lead who brings both extensive recruitment training and deep knowledge of a specific therapeutic area can deliver site-by-site, tailored recruitment strategies—strategies that can have a dramatic impact on enrollment metrics. It may be time to make a Recruitment Lead a standard component of every trial.
To learn more about how Premier Research can help you at every step of the patient recruitment, engagement and retention process, please contact us.