Unmet Clinical Need Extractor

Use the reference modules as follows:

• references/clinical-need-unit-framework.md → use when defining the exact clinical need unit in Section A.
• references/patient-journey-framework.md → use when locating unmet needs across screening, diagnosis, stratification, treatment selection, response assessment, monitoring, relapse management, and survivorship in Sections B–E.
• references/unmet-need-type-framework.md → use when classifying unmet-need types in Sections C–F.
• references/evidence-source-hierarchy.md → use when prioritizing guidelines, consensus documents, reviews, real-world evidence, registries, and original studies in Sections B–D.
• references/need-strength-rules.md → use when deciding whether an unmet need is strongly established, partially supported, context-dependent, or weakly supported in Sections C–F.
• references/translation-linkage-rules.md → use when converting clinical need into research-value framing in Sections F–H.
• references/output-section-guidance.md → use as the section-level formatting and content control standard for Sections A–I.

If the output does not visibly reflect these modules, the result should be treated as incomplete.

Input Validation

Valid input: [disease area / care problem / treatment context / biomarker-use case / clinical workflow stage] + [request to identify unmet clinical needs / clinical pain points / where current care is insufficient]

Optional additions:

• disease stage or line of therapy
• population constraints
• geography or care-setting constraints
• guideline focus
• real-world evidence emphasis
• biomarker or translational interest
• intervention class or treatment modality
• anchor papers, reviews, or guidelines

Examples:

• “Extract the key unmet clinical needs in early pancreatic cancer.”
• “What are the unmet needs in immunotherapy selection for metastatic urothelial carcinoma?”
• “Identify the main unmet clinical needs around MRD-guided management in colorectal cancer.”
• “Where are the real clinical pain points in sepsis risk stratification?”

Out-of-scope — respond with the redirect below and stop:

• patient-specific treatment recommendations
• broad disease summaries without any request to identify unmet need
• product positioning or investment advice unrelated to clinical unmet need
• unsupported claims that a disease area has “huge unmet need” without retrieved evidence

“This skill extracts unmet clinical needs at the disease, pathway, or care-workflow level. Your request ([restatement]) requires patient-specific guidance, broad disease education, or unsupported market-style claims, which are outside its scope.”

Sample Triggers

• “What are the biggest unmet clinical needs here?”
• “Where does current care still fail?”
• “What clinical pain points would justify this research direction?”
• “What are the real unmet needs in this disease area?”
• “What do guidelines and real-world studies suggest is still not solved?”
• “How can I frame the research value around a true clinical need?”

Core Function

This skill should:

1. define the exact clinical-need unit under review,
2. retrieve guidelines, reviews, and relevant real-world or practice-oriented evidence,
3. locate where along the patient journey the current unmet needs occur,
4. classify unmet needs by type and strength,
5. distinguish true clinical pain points from generic importance language,
6. identify which needs are already well established versus context-specific or weakly supported,
7. translate the unmet-need map into stronger research-value framing,
8. identify the most clinically meaningful need if prioritization is required.

This skill should not:

• call every disease burden statement an unmet clinical need,
• confuse scientific curiosity with clinically meaningful pain points,
• treat biomarker enthusiasm as proof of unmet need,
• present vague “better outcomes are needed” language as a specific need map,
• ignore differences in stage, line of therapy, or care setting,
• present broad impressions as if they were evidence-backed clinical-need extraction.

Execution — 8 Steps (always run in order)

Step 1 — Define the Clinical Need Unit Precisely

Identify and restate:

• disease / condition,
• disease stage / line of therapy / workflow phase,
• population or care-setting constraints,
• specific clinical problem under review,
• whether the need is broad or use-case-specific,
• and whether the user wants full need extraction or prioritization for research framing.

If the input is too broad, narrow it before formal extraction. State assumptions explicitly.

Step 2 — Retrieve Clinical-Need Evidence Sources

Retrieve evidence relevant to real clinical unmet need before formal judgment.

Prioritize:

1. recent guidelines, consensus statements, and major reviews for explicit care-gap framing,
2. real-world studies, registries, and observational practice evidence for failure modes and variability,
3. original clinical studies when they clarify unmet-need mechanisms,
4. clearly labeled preprints only as supplementary recency signals.

Do not rely on disease burden language alone. Look for explicit or strongly inferable clinical pain points.

Step 3 — Map the Patient Journey and Failure Points

Locate where current care underperforms across the pathway, such as:

• early detection,
• diagnosis,
• risk stratification,
• treatment selection,
• treatment response prediction,
• response monitoring,
• relapse detection,
• resistance management,
• toxicity trade-offs,
• access or implementation barriers,
• or survivorship follow-up.

Keep this structured rather than narrative.

Step 4 — Classify the Unmet Need Types

Classify each unmet need by type, such as:

• screening / early-detection gap,
• diagnostic gap,
• subtype-definition gap,
• risk-stratification gap,
• treatment-selection gap,
• response-prediction gap,
• monitoring gap,
• relapse or progression-management gap,
• toxicity-management gap,
• implementation or access gap,
• or evidence-generation gap with direct clinical implications.

Do not merge clinically distinct gaps into one generic statement.

Step 5 — Judge Need Strength and Specificity

For each candidate unmet need, judge whether it is:

• strongly established,
• partially supported,
• context-dependent,
• or weakly supported / overstated.

Then specify why:

• guideline-level acknowledgement,
• repeated review-level emphasis,
• real-world performance problems,
• clear failure in current tools,
• heterogeneous outcomes,
• poor calibration or selection,
• practical implementation failure,
• or only generic burden language.

Step 6 — Separate True Pain Points from Generic Importance Claims

Distinguish:

• true care gaps,
• unresolved decision points,
• known tool limitations,
• operational implementation failures,
• and broad statements that sound important but do not define a specific unmet need.

Do not allow “better biomarkers are needed” or “precision medicine is important” to stand as sufficient extraction.

Step 7 — Link the Need Map to Research-Value Framing

Translate the validated unmet needs into research-value language.

Identify:

• which needs justify biomarker, diagnostic, stratification, prognostic, response-prediction, monitoring, or drug-development work,
• which need statements are strong enough to anchor a proposal or introduction,
• and which needs require narrower or more careful framing.

Step 8 — Perform Self-Critical Review

Before finalizing, check:

• whether generic burden was mistaken for unmet need,
• whether the extracted needs are too broad to be useful,
• whether the evidence over-relied on review rhetoric without care-gap specifics,
• whether stage or setting mismatches were ignored,
• whether translational links were overclaimed,
• and whether the final priority need is truly supported by retrieved evidence.

Mandatory Output Structure

A. Clinical Need Framing

• disease / condition
• exact clinical need unit
• scan objective
• scope boundaries
• assumptions made

B. Retrieval and Evidence Audit

• retrieval scope and source types
• approximate evidence composition
• what was included vs excluded
• where explicit unmet-need statements came from

C. Patient-Journey Need Map

Use a structured format to show where along the patient journey unmet needs are concentrated.

Include:

• workflow stage
• current limitation or failure point
• why it matters clinically
• strength of support
• confidence notes

Use a table only when multiple journey-stage comparisons materially improve clarity.

D. Structured Unmet-Need Classification

For each major unmet need include:

• unmet-need label
• need type
• stage / setting / population relevance
• what current care gets wrong or fails to solve
• evidence basis
• need strength

Use a table when parallel comparison improves decision quality.

E. True Pain Points vs Generic Importance Summary

Summarize:

• which unmet needs are strongly established,
• which are partly real but overgeneralized,
• which are highly context-dependent,
• and which statements are too generic to serve as strong clinical-need anchors.

F. Priority Unmet Clinical Needs

Identify the highest-priority unmet needs.

For each include:

• why it is clinically meaningful,
• why current care remains insufficient,
• what kind of solution would address it,
• and what type of research direction it most naturally supports.

G. Research-Value Translation

Explain how the strongest unmet need(s) can support research framing, such as:

• diagnostic development,
• risk stratification,
• prognosis,
• treatment response prediction,
• monitoring,
• target/pathway work,
• or implementation-oriented improvement.

Do not overstate translational readiness.

H. Most Actionable Framing Recommendation

Provide the strongest clinically grounded framing for the user’s likely research direction.

This should state:

• the single best unmet-need anchor,
• the safest precise wording,
• and the main caution against overclaiming.

I. Self-Critical Risk Review

State briefly:

• the strongest part of the unmet-need extraction,
• the most assumption-dependent part,
• the most likely overstatement risk,
• and what would most improve confidence.

J. References

Provide a references section whenever sources are available.

Prefer:

• guidelines and consensus documents,
• major reviews,
• real-world evidence and registry studies,
• and original clinical studies directly supporting the extracted unmet need.

Never fabricate references, PMIDs, DOIs, guideline status, or claims of clinical endorsement.

Formatting Expectations

• Keep the output structured, concise, and sectioned.
• Use short paragraphs and lists where they improve readability.
• Use tables only when they materially improve side-by-side comparison of unmet needs, workflow stages, or need strength.
• Do not force all sections into tables.
• Make the unmet-need wording clinically concrete rather than abstract.
• Separate explicit evidence-backed need statements from inference-based framing.
• Make uncertainty visible whenever need strength is limited or context-dependent.

Hard Rules

1. Always define the exact clinical need unit before extraction.
2. Always distinguish disease burden from unmet clinical need.
3. Always distinguish workflow-stage differences such as screening, diagnosis, treatment selection, monitoring, and relapse management.
4. Do not merge distinct unmet-need types into one generic statement.
5. Do not present biomarker or technology interest as proof of unmet clinical need.
6. Do not overgeneralize across stage, line of therapy, population, or care setting.
7. Do not treat review rhetoric alone as sufficient evidence of a major clinical pain point.
8. Link research-value framing only to unmet needs that are truly supported.
9. Use tables only when they improve comparison; do not force table-first formatting everywhere.
10. Keep the final framing clinically specific and operationally meaningful.
11. Never fabricate references, PMIDs, DOIs, guideline status, trial identifiers, endorsement claims, or real-world evidence status.
12. Never present vague field lore or unsourced beliefs as literature-backed unmet-need conclusions.
13. When citation certainty is insufficient, explicitly label the point as unverified, inferred, or evidence-limited.
14. Do not overstate translational implications beyond the extracted clinical need.
15. Treat the result as incomplete if the unmet-need map is not clearly supported by retrieved evidence.

What This Skill Should Not Do

This skill should not:

• write a general disease background section without extracting unmet need,
• give treatment advice for an individual patient,
• equate prevalence or mortality alone with a specific unmet clinical need,
• turn every research interest into a “major unmet need,”
• propose solutions before defining the pain point,
• or present a marketing-style value statement instead of a clinically grounded need map.

Quality Standard

A high-quality output from this skill should make a clinician-scientist or translational researcher say:

• “These are the real pain points, not generic disease statements.”
• “I can see where in the care pathway the need actually occurs.”
• “I know which unmet needs are strongly established versus weakly framed.”
• “The research value is now anchored in a clinically meaningful problem.”
• “The claims are careful, evidence-aware, and not inflated.”