EVIDENCE-BASED PICO MAPPING FOR EU JOINT CLINICAL ASSESSMENT (JCA) USING A REAL-TIME AI-ASSISTEDLIVINGSYSTEMATIC LITERATURE REVIEW (REAL-SLR): AN ADVANCED NON-SMALL CELL LUNG CANCER (NSCLC) CASE STUDY
Author(s)
Anna Forsythe, MBA, MSc, PharmD1, Neil Hawkins, MBA, MSc, PhD2, Stacy Grieve, PhD1, Rozee Liu, MSc1, Andrew Briggs, DPhil3;
1Oncoscope-AI, Miami, FL, USA, 2University of Glasgow, Oxford, United Kingdom, 3London School of Hygiene & Tropical Medicine, London, United Kingdom
1Oncoscope-AI, Miami, FL, USA, 2University of Glasgow, Oxford, United Kingdom, 3London School of Hygiene & Tropical Medicine, London, United Kingdom
OBJECTIVES: The EU Joint Clinical Assessment (JCA) requires early, transparent, and evidence-based definition of Population-Intervention-Comparator-Outcome (PICO) frameworks. In advanced non-small cell lung cancer (NSCLC), the rapid emergence of antibody-drug conjugates (ADCs), evolving comparators, and reliance on subgroup analyses challenge traditional static systematic literature reviews (SLRs) for JCA planning. This paper presents a Real-Time AI-assisted Living SLR (REAL-SLR) approach for evidence-based JCA PICO mapping.
METHODS: A PRISMA-compliant REAL-SLR was conducted using protocol-driven searches updated continuously for advanced NSCLC. Evidence from interventional ADC trials, regulatory sources, clinical guidelines, selected high-quality real-world evidence, and technology assessments was continuously identified, screened, and structured. For each eligible study, data were extracted on study design, population, intervention, comparator, endpoints, and reported subgroup analyses. This continuously updated evidence-base REAL-SLR was used to define both core and extended JCA PICOs without re-running searches, enabling dynamic refinement while preserving auditability and methodological consistency.
RESULTS: As of January 8, 2026, the REAL-SLR identified 56 published ADC studies in advanced NSCLC, including 29 Phase 2 or Phase 3 trials. Six Randomized-controlled trials (RCTs) - excluding 20 interventional non-RCTs and 3 pooled analyses - evaluated 5 distinct ADCs against two comparator strategies: docetaxel and platinum-based chemotherapy. These five interventions and two comparators defined the evidence-anchored core PICOs for JCA planning. Extended PICOs were mapped using available subgroup evidence, including biomarker-defined populations (actionable genomic alteration [AGA]-positive tumors stratified by specific AGA expression; AGA-negative tumors stratified by PD-L1 tumor proportion score), prior therapy exposure, and prognostic characteristics (i.e. brain metastases).
CONCLUSIONS: REAL-SLR-enabled PICO mapping anchors JCA scoping in the evolving ADC evidence landscape rather than a single trial design. By distinguishing evidence-anchored core PICOs based on interventions and sub-populations in published studies, this approach improves transparency, reduces rework, and enhances preparedness for JCA in rapidly evolving oncology indications.
METHODS: A PRISMA-compliant REAL-SLR was conducted using protocol-driven searches updated continuously for advanced NSCLC. Evidence from interventional ADC trials, regulatory sources, clinical guidelines, selected high-quality real-world evidence, and technology assessments was continuously identified, screened, and structured. For each eligible study, data were extracted on study design, population, intervention, comparator, endpoints, and reported subgroup analyses. This continuously updated evidence-base REAL-SLR was used to define both core and extended JCA PICOs without re-running searches, enabling dynamic refinement while preserving auditability and methodological consistency.
RESULTS: As of January 8, 2026, the REAL-SLR identified 56 published ADC studies in advanced NSCLC, including 29 Phase 2 or Phase 3 trials. Six Randomized-controlled trials (RCTs) - excluding 20 interventional non-RCTs and 3 pooled analyses - evaluated 5 distinct ADCs against two comparator strategies: docetaxel and platinum-based chemotherapy. These five interventions and two comparators defined the evidence-anchored core PICOs for JCA planning. Extended PICOs were mapped using available subgroup evidence, including biomarker-defined populations (actionable genomic alteration [AGA]-positive tumors stratified by specific AGA expression; AGA-negative tumors stratified by PD-L1 tumor proportion score), prior therapy exposure, and prognostic characteristics (i.e. brain metastases).
CONCLUSIONS: REAL-SLR-enabled PICO mapping anchors JCA scoping in the evolving ADC evidence landscape rather than a single trial design. By distinguishing evidence-anchored core PICOs based on interventions and sub-populations in published studies, this approach improves transparency, reduces rework, and enhances preparedness for JCA in rapidly evolving oncology indications.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PT2
Topic
Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
SDC: Oncology, SDC: Respiratory-Related Disorders (Allergy, Asthma, Smoking, Other Respiratory)