CORE
Community-aware education
Patient and family materials calibrated for small, connected rare disease communities where information travels fast and one experience shapes many. Patient advocacy collaboration where relevant.
Every patient is irreplaceable.
There is no rescue recruitment.
Rare disease trials operate at a scale where conventional retention strategies are meaningless.Populations are tiny.Margin is zero.
The readiness profile.
Diagnostic exhaustion from years of uncertainty before trial participation even begins. Geographic burden that may require relocation, repeated international travel, or sustained remote participation infrastructure.
Intense caregiver dependency where the caregiver is not a support resource but a structural requirement for participation. Small communities where information asymmetry creates misaligned expectations, and where one patient's experience shapes the readiness of others. Populations of 30 to 80 patients globally. No rescue pool.
Where dropout concentrates.
Everywhere. Any stage. With populations this small, there is no stage where dropout is expected or tolerable.
A single patient lost during screening, two patients lost during early participation, one patient lost at mid-study: each of these can individually derail the trial's statistical viability. There is no concentration pattern because there is no margin anywhere. Every transition is a managed decision.
What CORE and PRISM govern in rare-disease trials.
CORE delivers community-aware, caregiver-co-built education. PRISM applies zero-tolerance governance to every transition.
CORE
Caregiver-as-co-participant content
Caregiver education built for sustained, intensive involvement across 18 to 36 month timelines. Role definition, burden translation, decision support governed with equal rigor to the patient.
PRISM
Pre-enrollment feasibility validation
Can this family sustain this protocol for 18 months? Is the geographic burden manageable? Are caregiver resources durable? Every patient validated individually before advancing.
PRISM
Zero-tolerance readiness monitoring
Real-time signal monitoring across every patient. Immediate intervention on any decay signal. No drift tolerated because there is no replacement pool.
A 40-patient rare disease trial operating across 12 countries cannot afford a single preventable dropout. Every patient transition is a governed decision because at this scale, every patient is the trial. There is no rescue pool. There is no enrollment extension that solves a retention failure.
Frequently Asked Questions
What makes rare disease trials uniquely vulnerable to dropout?
Rare disease trials operate with tiny populations, sometimes 30 to 80 patients globally. There is no rescue recruitment pool. Patients carry diagnostic odyssey fatigue. Geographic dispersion creates extreme travel burden. Caregiver dependency is total. Losing even one or two patients can jeopardize the entire program.
Can CORE and PRISM support ultra-rare trials with fewer than 50 patients?
Yes. The readiness model shifts to zero-tolerance governance. Every patient receives individualized feasibility validation before enrollment. Geographic burden is modeled explicitly. Caregiver sustainability is assessed for the full trial duration. Real-time readiness monitoring runs continuously.
How does caregiver readiness work in a rare disease trial?
The caregiver is treated as a co-participant. CORE produces caregiver-specific education with equal rigor to patient education. PRISM validates and monitors caregiver readiness alongside the patient. If the caregiver cannot sustain the role, the patient cannot sustain the protocol.
How do you address community-level dynamics in small rare disease populations?
Information travels fast in small connected communities. One patient's experience shapes the readiness of others. CORE produces community-aware materials, often in collaboration with patient advocacy organizations. PRISM monitors community-level signals where ethical, building readiness across the cohort as a network.
Send us your protocol and site list.
In two days, you get three execution diagnostics on your program.
01 · The Baseline
Trial Readiness Index
How likely each eligible patient cluster is to activate, persist, and complete, before any intervention.
02 · The Diagnosis
Readiness Friction Map
The barriers most likely to suppress activation, enrollment, and completion in each cluster, and how to mitigate them.
03 · The Prescription
Readiness
Blueprint
Which clusters to target, which barriers to address, which interventions to deploy, and what completion lift to expect.