As clinical trials grow in volume and diversity, drugs sponsors, CROs, sites, and vendors must adopt strategies that help improve patient engagement, experience, and retention. Unfortunately, when budgets are limited and sites are overburdened, the quality of the patient experience tends to suffer, leaving a trial feeling transactional or worse for patients. Failing to ensure a positive, tailored experience for trial participants can yield major ramifications, including reduced patient retention and elongated trial timelines.
To preserve the quality of care and build a more effective approach to trial design overall, a sponsor must consider their approach to patient recruitment and enrollment early and often. While traditional patient recruitment strategies have proven beneficial in specific types of trials – typically those that appeal to wide swaths of the population, like vaccines – an increasingly complex array of trials are calling for a more diversified approach to recruitment. Leveraging a more targeted recruitment strategy for your trial is a critical step toward creating a high-quality patient experience from start to finish while reducing site burden and improving trial outcomes.
Patient enrollment in clinical trials is an ongoing bottleneck for sponsors and trial teams. Reports indicate that more than 80% of clinical trials globally fail to enroll patients within the targeted amount of time.1 There are several underlying factors that cause trials to miss their enrollment deadlines, some of which include poor planning and trial design; misuse or misappropriation of funds, which leaves a limited budget to devote to enrollment; and patient attrition and dropout due to the inability to process patients efficiently. Often, trials simply fail to meet patients where they are.
In many cases, sites are asked to overcommit to the number of patients they can enroll to align with study enrollment objectives. If a site commits to securing 50 patients for a trial but only recruits 5 patients, this leaves a significant patient gap that must be filled. The downstream impact is that the budget was not earmarked for a robust patient recruitment strategy that targets trial participants who fit the relevant criteria. As a result, sponsors find themselves in a budget deficit from which they are running out of time and money to recruit high-quality patients, often leading to an extension of the enrollment period. For example, if a trial starts on a twelve-month timeline and sites fall behind on their initial sourcing efforts in the first three months, a trial team is now down to nine months to gather and move the majority of patients through the trial on a compressed timeline.
Overall, a clinical trial requires a delicate balance of speed, quality, and efficiency, and when one component falls behind, the others are likely to suffer. As the deadline for enrollment approaches, sponsors could become desperate to meet their desired patient quota, which could lead to reduced patient quality, i.e., the degree to which the patients enrolled reflect the target population of the study, and yield negative downstream effects that impact trial quality.
In the traditional model for patient recruitment, a recruitment team conducts digital, direct-to-patient acquisition. Marketing materials are created and then leveraged across digital platforms based on the target age and demographic of the intended patient. Ideally, patients are attracted through a call to action within a digital ad that leads them to an online or phone screening. Patients will then go through a pre-approved pre-screener to identify those who meet inclusion criteria. Selected patients are then scheduled for an onsite office visit, where they, hopefully, consent to participation and, eventually, randomization.
As the clinical trial industry continues to evolve, a one-size-fits-all approach to patient recruitment will likely fail to reach patients within highly specific target populations. Therefore, sponsors must leverage a more varied approach to execute diverse and inclusive trials that accommodate underserved populations, including those that may not have reliable access to the internet.
A diversified strategy might include more localized efforts to reach patients via non-digital touchpoints, including direct to neighborhood outreach with events, walks, distributed materials, and physician engagement. Recognizing that the traditional approach may not be the right avenue for the patients you are trying to reach is critical; from there, you can adapt your recruitment strategy to best serve the patients you are seeking.
To build a more-patient centric model to patient recruitment, it is best to start at the source: the patients. Begin by involving patients in the earliest stages of trial planning by partnering with patient advocacy groups. Together, key stakeholders can receive guidance on how to ease or accommodate any potential strain on the patients they are targeting, including travel and overnight stays. As you create a recruitment strategy, it is critical to consider the patient perspective when identifying where improvements and accommodation should be made. Furthermore, the beginning of a trial is not the only time when it is important to factor in the patient perspective. Conducting surveys throughout a trial can help sponsors, CROs, and vendors collect and incorporate patient feedback about what went well and what didn’t and then apply this data in the design of future trials
Beyond fostering an enhanced patient voice in trial design, there are also adjustments that can be made amongst key stakeholders. The clinical industry tends to work in silos despite the shared goal of bringing life-changing therapies to patients. However, improving the overall patient experience requires sponsors, CROs, and vendors to work more collaboratively, learning from each other’s experiences and improving in ways that are complementary.
In general, recruitment teams ― and trial teams as a whole ― should minimize interactions that may feel transactional to trial patients. It is critical to foster a positive, high-quality experience in which patients build familiarity with a recruitment specialist who ensures they are comfortable and well-educated on what the trial will entail. A recruitment team should strive to have empathy for the patient experience, which, ideally, will help foster greater trust between them and the patients they serve.
When these soft elements are prioritized, a patient is more likely to stay engaged after their first visit, continuing to show up for their appointments as needed. It is also important to send updates to the patients, including newsletters that provide greater insight into the trial, i.e., how it is progressing, relevant data, and a better sense of what this research could mean for the broader medical community. These components and more can help ensure that a patient feels as though they are a part of a greater mission and not just a cog in a machine.
Designing more patient-centric trials and recruitment approaches has one obvious impact: patient retention. The better the patient experiences, the more likely they are to continue to participate throughout the length of the trial; this includes everything from pre-screening to scheduling to education and consent. From a broader perspective, patients who have positive clinical trial experiences are more likely to be champions of clinical research to the people in their lives. As word spreads positively for the clinical research experience, more patients will be willing to participate.
Beyond increased patient retention, there is also the opportunity for your patient recruitment partner to help support sites. The more that a recruitment company is willing to take on, the more site burden is alleviated. Though site augmentation services are not a necessary component of a patient recruitment package, these are services that, if opted into, can yield major benefits for trial teams. A patient recruitment team can assist with reminder and follow-up calls, secondary screenings, chart review, and medical record retrieval and review. As a result, site teams can focus on other critical responsibilities that contribute to the successful execution of the trial.
Sponsors that seek to make their clinical trials more accessible, more appealing, and more positive for patients overall must make recruitment a top priority. A one-size-fits-all approach will likely fail to attract a variety of patient types, especially as trials continue to evolve. To improve the patient experience, work with patient advocacy groups from the earliest stages of trial planning and develop a diversified and well-rounded approach to patient recruitment.
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