USE CASE

Clinical Trial Decisions

Identify response and resistance biomarkers and refine your next trial phase.

Identify response and resistance biomarkers and refine your next trial phase.

Identify response and resistance biomarkers and refine your next trial phase.

Use early clinical trial data with relevant external evidence to understand responders and non-responders, identify biological signals, and determine how the next phase should change.

Discuss a Program

Discuss a Program

THE CHALLENGE

What does the early trial data tell us about who benefited—and why?

What does the early trial data tell us about who benefited—and why?

What does the early trial data tell us about who benefited—and why?

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We have early clinical trial data. Before finalizing the next phase, we need to understand the cohort, identify differences between response groups, and determine whether a biomarker-defined subgroup is driving the signal.”

We have early clinical trial data. Before finalizing the next phase, we need to understand the cohort, identify differences between response groups, and determine whether a biomarker-defined subgroup is driving the signal.”

We have early clinical trial data. Before finalizing the next phase, we need to understand the cohort, identify differences between response groups, and determine whether a biomarker-defined subgroup is driving the signal.”

Turn early trial data into a clearer next-phase strategy.

01

Are there important baseline imbalances between response groups?

02

Which molecular, cellular, or histologic features distinguish responders from non-responders?

03

Which biological programs are associated with sensitivity, non-response, or acquired resistance?

04

Is the observed signal concentrated in a biologically defined subgroup?

05

Do response-associated signals replicate in relevant external cohorts or modalities?

06

Which biomarkers are sufficiently supported for next-phase enrichment or prospective validation?

07

What additional samples, assays, or endpoints would reduce uncertainty?

Scroll horizontally to review all seven questions.

From trial observations to next-phase decisions.

01

Characterize the trial cohort

Evaluate baseline characteristics, molecular features, sample availability, endpoints, and potential confounding factors.

02

Compare response groups

Identify molecular, cellular, histologic, and clinical differences between responders and non-responders.

03

Evaluate biomarker evidence

Test response and resistance signals across relevant modalities, subgroups, and external evidence.

04

Refine the next phase

Translate the findings into an enrichment strategy, biomarker validation plan, and recommendations for the next study design.

A decision package for phase transition.

Trial cohort characterization

A clear view of the study population, data completeness, baseline variation, and potential confounding factors.

Response-group analysis

A comparison of the biological and clinical features associated with response and non-response.

Response and resistance biomarkers

Prioritized biomarkers with effect direction, supporting evidence, limitations, and replication status.

Refined patient-selection hypothesis

A defined subgroup or enrichment hypothesis for evaluation in the next phase.

Next-phase validation plan

Recommended cohort analyses, assays, sample collection, and prospective tests needed to confirm the findings.

Built around treatment-linked evidence.

Built around treatment-linked evidence.

Built around treatment-linked evidence.

This workflow requires clinical trial data that connect treatment exposure with response or other defined endpoints. Molecular, pathology, and longitudinal samples can be incorporated when available.

This workflow requires clinical trial data that connect treatment exposure with response or other defined endpoints. Molecular, pathology, and longitudinal samples can be incorporated when available.

Study design and treatment arms

Baseline clinical characteristics

Treatment exposure

Response and outcome labels

Genomics and transcriptomics

Single-cell or spatial data

Digital pathology

Longitudinal and recurrence samples

Clyra should distinguish exploratory associations from analytically replicated or prospectively validated biomarkers.

Clyra should distinguish exploratory associations from analytically replicated or prospectively validated biomarkers.

DISCUSS A PROGRAM

Make the early data more useful before the next phase begins.

Tell us about the study, endpoints, available samples, and the decision your team needs to make.

Discuss a Program

DISCUSS A PROGRAM

Make the early data more useful before the next phase begins.

Tell us about the study, endpoints, available samples, and the decision your team needs to make.

Discuss a Program

DISCUSS A PROGRAM

Make the early data more useful before the next phase begins.

Tell us about the study, endpoints, available samples, and the decision your team needs to make.

Discuss a Program