Cellular Therapy Trials in Rheumatology: Is Your Site Model Ready?
Four site readiness questions for cellular therapy trials in rheumatology, covering specialist coordination, treatment delivery and patient follow-up.
Rheumatologists understand the disease and patient population; hematology/oncology colleagues bring experience in cellular therapy administration and associated care. Bringing cellular therapies into autoimmune disease trials requires close coordination between rheumatologists and hematology/oncology specialists.
That partnership needs to take shape during early clinical trial planning. Where will treatment occur? Who will oversee each stage of care? How will patients transition between teams for treatment and ongoing follow-up?
David True, DO, FACR, Senior Medical Director at Syneos Health, outlines four questions to help rheumatology clinical trial teams assess whether their proposed site model connects the expertise and capabilities their study requires.
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Question #1: Can the Site Support A Cell Therapy Treatment Pathway?
Cellular therapy experience is a starting point for feasibility discussions. Sponsors still need to establish whether that experience fits the specific investigational product, protocol and patient population. It’s important, especially in a newer treatment area that’s new to patients and caregivers as well as healthcare providers (HCPs), like cellular therapy in autoimmune disease, is centered as the main way to explore treatment.
Begin by mapping the proposed patient journey: screening, preparation, treatment, monitoring and longer-term follow-up. Identify which team would perform each activity and where it would happen. That exercise can expose dependencies that a conventional site questionnaire may miss. A site might have access to appropriate participants but depend on another department or institution for treatment. The relevant specialists may be available, but their capacity and working arrangements still need to be established.
“The practical question, really, is whether those capabilities can function together within the study’s requirements,” cautions Dr. True.
Question #2: Who Owns Each Part of the Patient Journey?
Dr. True described one potential arrangement in which a rheumatologist serves as principal investigator, draws on hematology/oncology expertise for specialized treatment and continues the patient’s longer-term follow-up.
The appropriate arrangement will depend on the study. What matters is making responsibilities explicit.
Before activation, teams should establish:
- Who evaluates disease activity and eligibility?
- Who oversees treatment and protocol-required monitoring?
- How will clinical information move between specialists?
- Who coordinates subsequent visits and ongoing follow-up?
These discussions give teams an opportunity to identify gaps or overlapping responsibilities while the operating model can still be adjusted.
Question #3: How Will Collaboration Work in Practice?
Having both specialties available does not automatically establish a workable partnership.
Dr. True identified proximity, contracting and communication as practical challenges when connecting rheumatology and cellular therapy expertise. Sponsors need to understand how the proposed collaboration would function within each institution.
Can the teams accommodate the same study timelines? Are the necessary agreements in place? If care spans locations, how will patients navigate those transitions?
Site feasibility should examine the working relationship between teams alongside their individual qualifications. An established collaboration may offer a different starting point from one that must be built for the study.
Question #4: Has the Protocol Been Tested Against the Operating Model?
A protocol assigns procedures and timings. The site must translate them into appointments, staff responsibilities and coordinated care.
Involving the relevant specialists before protocol finalization allows sponsors to examine that translation. Teams can walk through a representative participant’s journey and identify where departmental schedules, treatment capacity or handoffs could create difficulty. That review also provides a basis for discussing which requirements are essential and where operational adjustments may be possible.
Plan the Partnership Before Activating the Site
For sponsors, the next step is to bring the proposed rheumatology and hematology/oncology teams together and walk through how they would deliver the protocol. Establish who performs each activity, where patients receive care and how information follows them between teams.
Those conversations can reveal whether a site has a workable treatment pathway—and what needs to be resolved before participants begin moving through it.
Connect with our team to learn more about cellular therapy in rheumatology.
Contributors
David True, DO, FACR
Senior Medical Director | Syneos Health
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