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Trial stratification evidence

Surface predictive and prognostic subgroup evidence with population modifiers and conflicting-effect flags. Motif does not enroll patients or run clinical decision support.

The pipeline

How Motif surfaces stratification evidence

Search, extract, inspect modifiers, and detect flips. This is literature evidence for trial design, not patient enrollment. For enrichment design context, read our blog on patient stratification in clinical trials to learn more.

Plain-language input

Ask about predictive
and prognostic biomarkers

Ask which biomarkers predict treatment benefit or prognosis in a disease context. Motif searches PubMed, PMC, and Europe PMC, screens relevance on title and abstract, and extracts associations with predictive and prognostic predicates. For checkpoint inhibitor predictors, read our blog on immunotherapy biomarkers to learn more.

  • Predictive associations require a therapeutic target and comparator when reported
  • Prognostic associations link biomarkers to outcomes in the studied population
  • Filter the Association Library by enrollment-defined stratum or interaction p-value

Hi Alex, what would you like to explore?

Predictive biomarkers for pembrolizumab in NSCLC
Subgroup effects of PD-L1 by TPS cutoff
Prognostic markers in HER2+ breast cancer trials
Stratification flips for EGFR across sex
Association Library
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1. PD-L1 TPS ≥50% predicts improved PFS on pembrolizumab vs chemotherapy in untreated NSCLC (HR=0.50, 95% CI: 0.37–0.68, RCT n=305)

↓ Supporting Evidence (2)

Moderate
↓ View⎘ Copy

2. Tumor mutational burden-high is prognostic for shorter OS in males but not females with advanced melanoma (interaction p=0.02, n=810)

↓ Supporting Evidence (2)

Moderate
↓ View⎘ Copy

3. HER2 amplification predicts trastuzumab benefit in metastatic breast cancer (HR=0.67, comparator present, validation cohort n=287)

↓ Supporting Evidence (3)

High
↓ View⎘ Copy

Association library

Extract clinical evidence

Motif reads full text and emits association sentences with effect sizes, study design, and GRADE-adapted evidence tiers. Each claim links to a PMID. Discovery and validation cohorts appear as separate associations when papers report independent replication.

  • 69 biomedical entity types and 41 relationship types including predictive and prognostic
  • Population modifiers: demographic, stage, molecular subtype, line of therapy, cohort identifier
  • Enrollment-defined strata flagged when the paper selected patients by the biomarker

Subgroup context

Inspect modifiers and
interaction evidence

Open any association to see biological context modifiers with stratum sample sizes, comparator presence, and interaction p-values. This is the evidence layer trial designers need before writing enrichment criteria, not an automated patient-selection engine.

  • Modifier categories include demographic, stage, risk stratification, and cohort identifier
  • Comparator and p-interaction fields surfaced for predictive claims
  • Supporting quotes and figure interpretations linked to source PMIDs

Association detail

PD-L1 TPS ≥50% predicts improved PFS on pembrolizumab vs chemotherapy in untreated NSCLC

Actor

PD-L1 (protein)

Predicate

predictive

Target

pembrolizumab (therapeutic)

Biological context modifiers

TPS ≥50%Molecular subtype
n=274
TPS 1–49%Molecular subtype
n=281
Previously untreatedLine of therapy
n=556
Comparator: Yesp-int: 0.02HR 0.50 (0.37–0.68)
Moderate
PMID 30955977

Stratification flip detection

2 opposing effects across strata

Review

TMB-highpembrolizumab response

Modifier category: Demographic

Male

predictive benefit

Female

no significant benefit

Severity: Moderate

EGFRMAPK pathway activation

Modifier category: Stage

Stage III

Higher expression

Stage IV

Lower expression

Severity: Low

Conflicting subgroups

Detect stratification flips
across strata

Motif compares biomarker effects across subgroups and flags when the same marker shows opposing results in different strata, for example benefit in one sex but not another. Broader conflicts across studies are surfaced separately so you can see where published evidence disagrees. Read our blog on personalized medicine biomarker analysis to learn more about broader precision-medicine context.

  • Flip severity reflects the lower GRADE-adapted certainty of the two strata
  • Results cite the underlying PMIDs so you can verify in source papers
  • Export associations and reports for protocol or SAP background sections

Patient Stratification FAQ

What Motif does and does not do for trial design

Does Motif enroll or select patients for trials?

No. Motif surfaces published biomarker evidence with subgroup modifiers and PMIDs. It does not access patient records, run clinical decision support, or assign patients to treatment arms. Your team uses the extracted evidence to design enrichment criteria and inclusion rules.

What is the difference between predictive and prognostic evidence?

Predictive associations link a biomarker to differential treatment benefit. They require a therapeutic target and often a comparator arm. Prognostic associations forecast outcome in the studied population regardless of treatment contrast. Motif extracts both with distinct predicates and surfaces comparator and interaction fields where reported.

What are population modifiers?

Modifiers describe the subgroup context of an association, for example stage, molecular subtype, demographic group, or discovery vs validation cohort. They appear in the association detail panel with stratum sample sizes and category labels drawn from Motif's 16 modifier categories.

How does stratification flip detection work?

Motif compares associations for the same biomarker and outcome across different subgroup values within one modifier type, such as sex, stage, or line of therapy. When effects point in opposite directions, Motif flags the pair with a severity level based on evidence certainty. Review the cited papers before changing enrollment criteria.

Can I filter to enrollment-defined strata?

Yes. The Association Library supports filters for enrollment-defined stratum, comparator presence, maximum interaction p-value, minimum evidence certainty, and biological context. These filters help you focus on evidence where the paper explicitly selected patients by the biomarker.

What are the limitations?

Evidence quality depends on what authors report in abstracts and full text. Subgroup analyses are often underpowered or exploratory. Motif does not replace biostatistical review of your protocol. Scope depends on your plan: Starter searches up to 5 papers per query, Pro up to 40. Verify key subgroup claims in the source papers.

Start building your stratification evidence base

Join researchers using Motif to find predictive and prognostic biomarker evidence from published literature.

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Trial stratification evidence - Motif