Therapeutic Surveillance Program
Patients with Sjögren’s disease have long voiced a persistent frustration: their illness does not fit neatly into the confines of a standard 20-minute clinic visit. Symptoms fluctuate, organ involvement evolves, and the disease often hides in the weeks between appointments. Many patients feel unheard because the traditional structure of outpatient medicine is poorly suited to a condition defined by complexity.
However, I see a slightly different reality in clinical trials.
The "Care Effect"
Clinical trials reveal what happens when the gaps in care are closed. It is a well-documented phenomenon in rheumatology: even when a new investigative drug fails to statistically separate from the placebo group, both arms often show improvement in disease activity and symptom scores.
There are likely many reasons for this. It is important to clarify that "placebo" in these high-stakes trials rarely means "no treatment." Participants in the placebo arm typically remain on their background immunomodulatory therapies (the standard of care they were already taking, such as hydroxychloroquine or other immunomodulatory medications). Yet, despite remaining on the same baseline medications, their condition often improves once they enter the study protocol.
In the field, we often debate this response in the placebo group. But to dismiss it as merely psychological trivializes the physiology of chronic illness. In my opinion, the placebo arm improvement proves a powerful medical truth: Drugs work better when the care structure around them is optimized. The rigorous ecosystem of a trial (frequent calibration, systematic scoring, and enforced adherence) acts as a force multiplier for the medication the patient is already taking.
The Discipline of Trials
As a researcher who designs and runs rheumatology clinical trials, I can attest that trials impose a cadence that routine care rarely matches. Participants are seen at predictable, frequent intervals (often every two to eight weeks) regardless of how they feel.
In a trial, symptoms are quantified, not generalized. Organ systems are tracked with rigorous methodology. Laboratory studies are drawn on a strict schedule. A single investigative team follows the patient longitudinally. In effect, the trial creates a disciplined ecosystem around the patient.
Why Structure Heals
To be precise, we must acknowledge the role of statistical "regression to the mean." Patients often enter clinical trials (or seek new doctors) when their symptoms are at a peak, and some natural settling of that flare is inevitable.
However, while regression to the mean may explain some initial improvements, it rarely explains the sustained responses we see in 48-week Sjögren’s trials. The magnitude and durability of the improvement seen in placebo groups often exceed what we would expect from the natural history of the disease alone. This concept suggests that the rigorous structure of the trial acts as a therapeutic intervention itself. I believe this stabilizes disease behavior through several mechanisms:
Interception: We catch inflammatory shifts before they spiral into flares.
Signal-to-Noise Distinction: Structured scoring helps distinguish between active disease activity, fixed damage, or transient discomfort.
Adherence & Safety: Continuity limits contradictory recommendations and improves medication compliance.
The Hawthorne Effect: The tendency to improve simply because one is being closely observed has measurable physiologic implications in chronic autoimmunity.
Introducing Therapeutic Surveillance
Importantly, none of this diminishes the critical role of pharmacologic therapy. When a new immunomodulatory agent is needed, it is prescribed. But the data suggests a complementary truth: Sjögren’s responds to care structure. Clarity is therapeutic. Predictability is therapeutic.
This is the intellectual foundation for a care model I provide: Therapeutic Surveillance Program.
Therapeutic Surveillance adapts the most effective elements of clinical trials to real-world practice. It involves scheduled touchpoints, structured symptom tracking, consistent interpretation of high-fidelity data, and proactive adjustments rather than reactionary ones. It is not "extra testing" for the sake of data; it is a deliberate monitoring of a disease that is otherwise allowed to unfold haphazardly.
A Framework for Complexity
For Sjögren’s, this level of oversight is not a luxury; it reflects what the complex biology of the disease demands. Glandular and extraglandular manifestations evolve slowly. Autonomic dysfunction fluctuates. Fatigue waxes and wanes. Symptoms that seem minor one month can signal something consequential the next. A framework that mirrors the rigor of clinical trials allows these patterns to be recognized rather than missed.
Some may ask if increased monitoring leads to overtreatment. Evidence suggests the opposite: structured follow-up reduces unnecessary escalation by accurately identifying the source of symptoms. It prevents the "shotgun approach" of medicine by favoring precision.
The Future of Care
There is no question that Sjögren’s is in desperate need of new drugs. However, the future of care will not rely on medication alone. It will blend targeted therapies with high-fidelity monitoring.
For patients who value continuity and an organized strategy for a complex disease, I welcome a thoughtful discussion. Whether you require occasional high-level guidance or a continuous, clinical-trial-like rhythm, the goal remains the same: to move from reactive sick-care to proactive disease management.
If there is a single takeaway, it is this: medications matter, but the architecture of care matters too. When symptoms are tracked and disease behavior is followed with precision, the entire equation changes. Therapy becomes smarter. And the patient gains a clarity that standard models of care rarely provide.
Interested in Therapeutic Surveillance?
Because this model relies on deep, continuous data review, I maintain a cap on patient volume to ensure clinical-trial-grade attention for every individual. If you are looking to move beyond standard monitoring and engage in a data-driven partnership for your care, I welcome the conversation.