Development Decision Review

Use new biomarker findings to shape the next study.

Quickly assess new findings against internal studies so your team can decide what to test next.

Development Decision Review workflow overview

Make better study decisions
with new findings.

Quickly compare new findings with internal studies so scientific leaders can decide what to test next.

Start with: Earlier study results + new finding
Prepare: A clear question for the next study
Team decides: What to test and whether to continue

How it works.

Review the earlier study results

Agents search years of study reports, trial records, assay files, and decision memos to reconstruct what the team knew, why it acted, and which questions remained open.

01 / INTERNAL STUDYDECISION RECORD · 2024

What did the trial show?

Drug64 / 160 responded

Control64 / 160 responded

No overall response difference. The biomarker subgroup still needs confirmation.

Source: Program A trial report + decision memo

Earlier study decision · Jun 2024

What the study found

Trial response was the same with drug and control. The subgroup result needed confirmation.

Study result: No higher response rate than control
Open question: Does the marker identify patients who benefit?

↳ Decision memo + study report

Check what the new finding means

Agents link results across studies, compare drugs, assays, and patient groups, and recalculate how missing records could change the finding.

02 / FINDING CHECKINTERNAL COMPARISON

Can the new result apply here?

Earlier studyProtein stainingDrug A · exploratory subgroup

New findingRNA activityDrug B · different test

Check before actingDo the tests identify the same patients?

Compare drug, assay, population, and missing samples

Compare the two biomarker tests

Do the tests identify the same patients?

The old test scores protein staining. The new test scores RNA activation. Their patient groups have not been shown to match.

Difference in response rates (percentage points)

Positive difference: +32.8
No difference: 0.0
Direction reverses: −15.6

The missing marker results are still unknown.

Plan the next study

Agents assemble the evidence, gaps, and testable next questions. Scientific leaders decide what the next study should test and approve further work.

03 / NEXT STUDYFOR TEAM REVIEW

Test whether the marker predicts benefit

Set the testChoose the assay and cutoff before analysis
Compare outcomesMeasure drug and control response in each group
Check independentlyRepeat with a separate study or sample

Scientific teamApproves the study question and next step

Scientific team review

✓ Plan the next study

The new finding does not yet show that this drug benefits patients in the marker-defined group.

Next study: Compare the two biomarker tests
Owner: Translational Science
What to learn: Whether the marker identifies patients who benefit from this drug