After the 25 participating sites had exhausted their existing patient databases, the Amylyx team needed to augment their recruitment strategy rapidly to meet clinical deadlines.
By expanding the recruitment channels available and providing an empathetic experience tailored to the specific needs of ALS patients and caregivers, Clara Health doubled recruitment rates and helped the trial reach full accrual in under 4 months.
products + services
ClaraCare Applicant Support
SiteSync Study Site Support
Key Performance Metrics
600,000 patients reached
18,000 patients signed up
140 patients connected to study sites
2x recruitment acceleration
3.5 months to conclude recruitment
The pharmaceutical client approached Clara Health 17 months into their Phase 2 clinical trial for a new treatment to potentially slow the progression of ALS.
After the 25 participating sites had exhausted their existing patient databases, the client sought out an external recruitment vendor that could rapidly move from contract signing through audience targeting, collateral creation, campaign setup, and IRB approvals to launch a patient recruitment operation and bring the trial to full accrual in just a matter of months.
The sponsor’s target population was ALS patients who began experiencing symptoms within the last 18 months with a slow vital capacity (SVC) greater than 60%, among other eligibility criteria.
In an effort to move as quickly as possible, the sponsor chose to work without the more involved recruitment channels due to the speed at which the campaign needed to begin running. The short timelines ultimately meant avenues such as digital pre-screeners, social media, partnerships with advocacy groups, patient influencers, clinics, online health communities, and boots-on-the-ground awareness campaigns were not utilized for recruitment. The full campaign was limited solely to digital advertisements directed to a trial website with a secure HIPAA-compliant contact capture form to deliver the enrollment rates desired.
Audience Analysis and Campaign Creation
Clara’s recruitment strategy leverages leading technology, but is defined by the human touch.
Technology, for example, helps Clara compile robust audience analysis. This analysis, however, would be far less effective if not done alongside patient and caregiver communities. Clara blends proprietary behavioral data with guidance provided directly by the relevant patient community, which amplifies the Clara team’s ability to provide compassionate support to each applicant throughout the entire enrollment process.
This approach is important in any indication, but even more so in a rare, complex, and rapidly-progressive condition such as ALS. This focus on empathy expands across each strategy brought to the recruitment effort by Clara. First, be they a caregiver, daughter, or a newly-diagnosed patient, Clara made sure to speak to each target audience with specificity in outreach; meeting them where they are in their healthcare journey, and speaking to their immediate concerns. This tailored language combined with robust support encouraged higher levels of engagement, and movement down the enrollment funnel.
Beyond specificity, it was just as important to present language that is approachable and digestible. In order to ensure legibility, our team worked hand-in-hand with the ALS community to craft every piece of recruitment collateral. Creating language to speak to patients who have just received a diagnosis of ALS is a very different process from creating language that speaks to experienced caregivers adding to their existing knowledge about the disease and its treatments. This empathy-centered practice increased engagement and created additional data points that helped identify optimal recruitment channels.
Further, every trial has its own unique advantages to potential applicants comparing it with other trials and existing treatment options. These can be uncovered through discussions with the patient community, and each dimension of the trial - from number of visits required to travel compensation provided - can be highlighted in campaign materials. Because different types of individuals care more or less about different aspects of the trial, each ad leads to a customized trial website with language emphasizing their primary topics of interest.
This effort is supported by the Clara platform’s ability to create multiple webpages with tailored messaging, and automatically detect which version of the trial page to show each visitor. Consistently showing understanding for the individual invites prospective participants to feel understood, even before they consider the study in full.
For this sponsor’s study, Clara deployed three separate campaigns to target different segments of outreach for ALS patients, their caregivers, and their loved ones. Each campaign was comprised of distinct digital ad units, webpages, outreach messaging, and imagery. The three campaigns, their associated custom-built websites, advertisements, as well as detailed guidelines for the enrollment support to be provided by Clara Health, were all delivered to the client’s central IRB within 20 days of contract signing.
There are digital tools that can provide all applicants with a smoother, faster enrollment experience: Digital pre-screening, e-consent, digital appointment scheduling, medical record aggregation support, and more can make each step in enrollment easier to graduate through than they would have been otherwise. But, technology alone does not solve every difficulty that arises in the course of the lengthy and often complex enrollment process.
Through the length of this campaign, for example, it was discovered that the most common issue confronting applicants was the average speed in site response, consistency in that communication, and anxiety that stemmed from not knowing exactly where their enrollment status stood at any given point.So, far more important than digital solutions such as the ones listed above, was the introduction of a 24/7 live applicant concierge service - ClaraCare - that worked with each patient who wished to join the trial. ClaraCare provided every patient with immediate answers to questions, at any hour of the day, through multiple communication channels (embedded website chat, HIPAA-compliant email, texting, and phone lines).
As a result, every patient was given an experience free of friction, confusion, hold times, or frustration. This service was maintained by full-time Clara Health team members, who listened to each unique participant’s needs in order to go above and beyond to maintain their engagement through the enrollment process. ClaraCare succeeded in moving the needle in recruitment because it was designed to meet the concerns of the patient and caregiver communities.
For example, one of the considerations brought up repeatedly by the ALS community was the need for flexibility in communication channels. When working with patients suffering from muscular deficiencies such as ALS, this proved especially crucial, as the symptoms of the disease absolutely influence each patient’s preferred mode of communication. Certain patients preferred text or email-based communications due to speech difficulties; others preferred phone calls, as muscle weakness in the arms or hands made typing or texting difficult or impossible. Providing accessible modes of communication allowed patients to comfortably communicate their questions and concerns while evaluating the study.
Another way in which ClaraCare achieved success was in the streamlining of the enrollment process for sites. One major hurdle, across many (if not most) trials is slowness in site response to applicants. Of course, no site coordinator works to be purposefully slow; however, in the course of their busy days, legacy tools, and long lists of to-dos, responses to patients may be deprioritized. Further, the sites may only reach out during traditional business hours, although patients may not be able to as easily respond during those hours.
To accommodate each site, coordinator, and their diverse workflows, Clara worked closely with the coordinators and PIs from each of the client’s sites to create an enrollment support plan to assist patients who were interested in the trial, empathize with their unique healthcare journey, and guide them through the next steps to enroll without increasing site burden. Understanding that each site’s situation is central to ensuring a seamless transition between a patient expressing interest in participating in the trial, and that each site works through different sets of challenges, Clara was able to help reduce response times, provide clarity to those patients in waiting, and ultimately drive up conversion rates from connecting to pre-screening to enrolling.
The other of this concierge work with each site was the procedure created by Clara to fit the criteria and goals of the study, while efficiently staying in contact with every patient and caretaker who applied to the study.
The procedure and tooling introduced helped Clara team members stay engaged with patients over a timeframe of up to 6 months to resolve any difficulties that had come up during the enrollment process in the client’s trial.
Over 875 emails, live chats, texts, and calls were carried out as part of the campaign to provide comprehensive support, with frequent proactive check-ins. These team members also assisted those who disqualified or remained on the waitlist after the trial had reached full accrual with identifying and connecting with alternate study options that they could participate in instead.
In the first month of Clara’s campaign activation, the client saw a 75% increase in scheduled screening visits. This trend continued to increase until Clara Health delivered full accrual just 3.5 months later, over a month earlier than projected timelines.
In the first month of Clara’s campaign activation, the client saw a 75% increase in scheduled screening visits. This trend continued to increase until Clara Health delivered full accrual just 3.5 months later, over a month earlier than projected timelines. The final month of the trial’s recruitment period saw a two-fold increase from the rate of enrollment prior to Clara’s involvement.
The typical applicant journey was as follows: Interested potential applicant sees an ad unit from one of three recruitment campaigns;Upon clicking, they would be brought to one of three corresponding study webpages; The visitor could then speak with a patient navigator before applying, or fill out a brief interest form online (Status: Applied).Upon applying, a Clara team member would reach out to them via their preferred communication channel to verify their submitted information, confirm their interest, and obtain their consent to introduce them to the chosen trial site.The applicant’s contact information would then be shared with the relevant site coordinator in a process customized for each site to make the transition as easy as possible, including mutual HIPAA compliant email introductions, directly sharing the caretaker’s contact information with the sites, or assisting the patient with filling out the site’s privacy release forms. (status: Connected with site)**Enrollment funnel conversion rates aggregated across three campaigns.
1) Enrollments were manually confirmed.2) Around 35 individuals remained in the "Applied" status at the end of the study as the client began waitlisting applicants in an effort to prevent over-enrollment. Therefore, the conversion rate from “Applied” to “Connected with site” is lower than the true value in this funnel.These individuals were assisted with finding other study options after enrollment officially closed.
Across the three campaigns, Clara reached over 600,000 individuals and generated 18,000 leads who requested information about the study. ClaraCare’s efforts were vital to the success of the campaign: 20% of visitors to the study pages immediately engaged with a concierge member, and that cohort represented almost one third of the total number of applicants connected to a study site. 140 individuals with ALS were referred to sites for screening, and 14 patients were enrolled into the clinical trial before accrual was met.
Clara Health went beyond developing a patient outreach campaign to uncover and resolve inefficiencies in the screening and enrollment operations at trial sites that were heavily impacting enrollment. As a part of regular check-ins with each applicant, the team discovered that 30% of patients (42 individuals) connected with sites were not given the opportunity to schedule screening calls or visits. Conversations with the impacted applicants revealed that many of these patients and caregivers never had a site coordinator reach out to them, or simply had communications discontinue from the site teams during the process scheduling in-peron screenings at the clinic.
Predictably enough, patients who were not receiving (or were waiting for response) from the sites quickly began to consider other options and lose interest in the study. Upon extensive review, two sites were found to be the source of the most obstruction in the trial’s enrollment funnel. Clara’s project managers worked with the sponsor, study coordinators, and affected patients to assist 10 of the 40 waiting patients with scheduling screening visits for the trial before the study fully accrued.
While the 2x acceleration delivered by Clara Health in just 3.5 months represented a massive cost savings for the client, acceleration could have been amplified by starting the services sooner, utilizing additional recruitment avenues outside of digital ads, and alleviating workload on trial coordinators through Clara’s digital screening and automated scheduling software. With more live campaign time, far more optimization through the minute-by-minute data collected would have also been possible to further accelerate enrollment rates.
Clara's Enrollment Platform brings together all the key components a clinical operations team needs to virtualize and decentralize their study enrollment experience.