How Profound’s embedded neurology model, proactive patient identification, and coordinated leukapheresis support helped drive enrollment in a complex CAR-T study
Clinical trials evaluating CAR-T treatment for myasthenia gravis can require sites to navigate both a narrow patient population and complex study procedures.
For one such neurology trial, narrow inclusion criteria, frequent dosing visits, and extensive neurological assessments and procedures created significant challenges for identifying, enrolling, and retaining qualified participants within the sponsor’s tight startup and recruitment timeline.
Profound Research combined its embedded model within physician practices with direct EMR access, early patient pre-screening, and coordinated support from a nearby qualified leukapheresis vendor.
The site went on to become the first site activated, first to screen a patient, and first to enroll a patient for the trial. Ultimately, the site randomized three participants and exceeded its original enrollment goal by 150%.
The Challenge: A Narrow Patient Population and Complex Study Requirements
Identifying qualified patients with myasthenia gravis was only one part of the enrollment challenge.
Narrow inclusion criteria limited the pool of potential participants, while frequent dosing visits and extensive neurological assessments and procedures created additional demands throughout study participation. Together, these requirements made identifying, enrolling, and retaining appropriate patients particularly challenging within a tight startup and recruitment timeline.
The CAR-T study also required leukapheresis, adding another procedural consideration that needed to be incorporated into site operations.
Success required the team to pair targeted patient identification with the operational coordination necessary to support the study’s more complex procedural requirements.
The Solution: Early Pre-Screening and Coordinated Procedural Support
Profound leveraged its embedded research model within physician practices and access to the EMR database to begin identifying potential participants before enrollment.
The team conducted targeted pre-screening searches and planned screening visits in advance, positioning the site to move quickly once enrollment activities could begin.
For the study’s leukapheresis requirements, Profound coordinated with a nearby qualified vendor to support the necessary procedures. This arrangement enabled the community research site to participate successfully in the CAR-T study while incorporating specialized procedural support from outside the site.
Combined with strong physician relationships and streamlined research operations, this approach helped the team move qualified participants through screening and enrollment efficiently.
The Outcome: Enrollment Goal Exceeded by 150%
The site’s preparation translated into both early study milestones and sustained enrollment performance.
Profound became the first site activated for the trial, followed by the first site to screen a patient and the first site to enroll a patient.
The site subsequently became the first to enroll three patients, ultimately randomizing three participants and exceeding its original enrollment goal by 150%.
Key Study Achievements:
- Exceeded the original enrollment goal by 150%
- First site activated for the trial
- First site to screen a patient
- First site to enroll a patient
- First site to enroll three patients
These results reflect the combination of targeted patient identification, physician engagement, and coordinated operational support required to execute a complex CAR-T study within a community research setting.
What This Means for Sponsors
Complex clinical trials can require capabilities that extend beyond the traditional operations of a community research site. That does not necessarily mean those studies must be limited to sites where every specialized procedure is performed in-house.
In this CAR-T myasthenia gravis trial, Profound combined patient access and research operations embedded within physician practices with specialized leukapheresis support from a nearby qualified vendor. This allowed the site to meet the study’s procedural requirements while maintaining the advantages of a community-based research model.
At the same time, EMR-driven pre-screening and advance visit planning helped identify potential participants and prepare the site for enrollment.
For sponsors, this case demonstrates how coordinated external resources, engaged physicians, and embedded research operations can expand the capabilities of community research sites to support more procedurally complex clinical trials.
Looking Ahead
Bringing complex studies into community research settings requires both patient access and the operational flexibility to support specialized protocol requirements.
In this CAR-T myasthenia gravis trial, Profound paired its embedded neurology model and EMR-based patient identification with coordinated leukapheresis support from a qualified nearby vendor. The site became the first activated, first to screen, and first to enroll—and ultimately exceeded its enrollment goal by 150%.
The results demonstrate how thoughtful operational coordination can help community research sites participate successfully in complex studies while expanding opportunities to advance research in challenging neurological conditions.