Eligibility tells you who qualifies. TRI measures whether participation can hold.
Executive summary
Clinical trials measure outcomes after risk becomes visible.
Trials measure medical eligibility, enrollment, retention, protocol adherence, site performance, and completion. What they generally lack is a comparable leading measure of whether an eligible patient is prepared to sustain the demands of participation.
The Trial Readiness Index, or TRI, is designed to measure that execution risk earlier. It evaluates readiness through the interaction of the patient, the protocol, and time, then identifies the social, behavioral, and protocol-fit frictions most likely to interrupt progression.
Baseline TRI → Friction Diagnosis → Intervention → Reassessment → Readiness Gain → Progression Monitoring → Readiness Decay Detection
What TRI predicts
One operating measure across six participation outcomes.
| Outcome | TRI question |
|---|---|
| Activation | How likely is the patient to engage and take the next step? |
| Prescreen progression | How likely is the patient to complete early qualification activities? |
| Consent | Can the patient understand the study, evaluate its burden, and make a durable decision? |
| Randomization | How likely is the patient to move from consent into active participation? |
| Persistence | Can the patient sustain study requirements over time? |
| Completion | Can the patient remain sufficiently ready through study closeout? |
Patient × Protocol × Time
Readiness is protocol-specific and longitudinal.
A patient may be highly ready for one protocol and poorly matched to another because the demands differ. Readiness can also improve or decline as motivation, caregiver capacity, logistics, confidence, burden, and life circumstances change.
Patient: behavioral tendencies, social conditions, treatment history, preferences, functional capacity, and support systems.
Protocol: visits, duration, procedures, sample collection, treatment burden, travel, washout, and consent complexity.
Time: the changing state of readiness before and throughout participation.
The readiness architecture
Sixty-two models become 19 operational frictions.
TRI organizes 62 readiness models into three domains. Twenty-one Social models address practical ability to participate. Twenty-nine Behavioral models address how the patient understands, evaluates, decides, and follows through. Twelve Protocol-Fit models assess compatibility between study demands and patient capacity.
Those signals consolidate into 19 Primary Frictions across four operational domains:
| Operational domain | Primary frictions |
|---|---|
| Understand and Decide | Trust, comprehension, cognitive load, decision confidence, protocol design fear |
| Access and Activate | Transport, cost, digital access and skill, language, care continuity |
| Sustain Participation | Schedule burden, caregiving burden, support system, functional limitation |
| Persist and Complete | Motivation, execution pattern, treatment fatigue, emotional and mood, material hardship |
Model Signal → Primary Friction → Targeted Intervention
Construction principles
TRI is more than an arithmetic average.
Every readiness dimension does not matter equally for every protocol or milestone. TRI weights should reflect model relevance, milestone relevance, evidence strength, protocol interaction, missing-data confidence, therapeutic area, cohort, and observed predictive performance.
A complete TRI output includes the normalized score, readiness band, Primary Frictions, Model Coverage, Assessment Confidence, and milestone-specific progression risk. A numerical score alone should never determine medical eligibility or access to participation.
The operating model
Measure. Diagnose. Intervene. Reassess.
- Baseline TRI: establish initial readiness and milestone-specific exposure.
- Friction diagnosis: identify what is suppressing progression.
- Targeted intervention: deploy support aligned to the specific friction.
- Reassessment: measure the updated readiness state.
- Readiness Gain: quantify improvement from baseline.
- Progression monitoring: determine whether improvement changes actual advancement.
- Readiness Decay detection: detect deterioration while intervention remains possible.
Readiness Gain and Readiness Decay
Readiness moves. The measure must move with it.
Readiness Gain = Current TRI - Baseline TRI
Readiness Gain measures movement after targeted support, but score movement alone is not enough. The consequential question is whether that improvement changes engagement, prescreen completion, consent, randomization, visit adherence, persistence, or completion.
Readiness Decay identifies a meaningful decline relative to the patient's prior state. It is designed to surface increasing burden, caregiver strain, travel fatigue, treatment frustration, anxiety, work disruption, expense, or motivational change before those conditions become visible as missed visits, nonadherence, withdrawal, or data loss.
Study and site intelligence
Patient-level signals become execution intelligence.
Individual readiness assessments can be aggregated into study, site, cohort, and milestone views. That gives sponsors visibility into Baseline TRI distribution, Readiness Gain, dominant Primary Frictions, progression risk, site-level variation, Model Coverage, and Assessment Confidence.
At the site level, TRI can clarify which patients need support, which friction is driving risk, which interventions have already been delivered, and whether readiness is strengthening or beginning to decay.
Validation and governance
Prediction earns credibility through calibration, confidence, and fairness.
TRI becomes operationally valuable when it predicts outcomes accurately enough to influence decisions. Validation should test discrimination, calibration, incremental predictive value, intervention response, longitudinal performance, generalizability, and fairness across relevant patient populations.
Model Coverage shows how much relevant evidence is available. Assessment Confidence reflects evidence volume, quality, recency, consistency, patient confirmation, behavioral observation, and protocol completeness. Identical TRI values can therefore carry different levels of certainty.
Readiness intelligence should trigger support. It should never become a shortcut for inappropriate exclusion.
TRI and economics
The operating measure connects to investment protected.
TRI is the operating measure. Readiness Gain is the change measure. Changed progression probability creates the bridge to investment protected, cost avoidance, and more credible completion economics.
TRI → Readiness Gain → Changed Progression Probability → Investment Protected
That financial framework is detailed in the companion white paper, The Economics of Patient Readiness.
Conclusion
Make readiness governable.
Clinical trial execution depends on the ability of patients to understand, decide, activate, navigate, persist, and complete. Those capabilities are shaped by social conditions, behavioral patterns, support systems, treatment experience, and protocol demands. They also change throughout participation.
TRI makes that readiness measurable, comparable, longitudinal, and actionable. It gives study teams a leading indicator that can be governed alongside enrollment, site performance, protocol compliance, retention, and operational risk.
Where is readiness likely to fail, what is driving that risk, and what can be done before failure affects enrollment, retention, or completion?
This publication is educational and does not provide medical, legal, regulatory, or financial advice. Trial-specific assumptions, readiness models, and progression estimates require appropriate clinical, operational, legal, privacy, fairness, and IRB review. © 2026 Jumo Health.