A LIVING SYSTEMATIC LITERATURE REVIEW FRAMEWORK FOR EU JOINT CLINICAL ASSESSMENT: REAL-TIME PICO SIMULATION TESTED IN AN ONCOLOGY INDICATION...
Author(s)
Sukriti Sharma, MSc1, Barinder Singh, RPh2, Rajdeep Kaur, PhD1, Sumeet Attri, MPharm1, Ankita Sood, PharmD1, Akanksha Sharma, MSc1, Shubhram Pandey, MSc1, Ritesh Dubey, PharmD1, Gagandeep Kaur, MPharm1, Pankaj Rai, MPharm1.
1Pharmacoevidence, Mohali, India, 2Pharmacoevidence, London, United Kingdom.
1Pharmacoevidence, Mohali, India, 2Pharmacoevidence, London, United Kingdom.
OBJECTIVES: The EU Joint Clinical Assessment (JCA) requires manufacturers to address consolidated evidence needs of all participating member states, often spanning many PICO (population, intervention, comparator, outcome) permutations under compressed timelines. Conventional one-off systematic literature reviews (SLRs) cannot accommodate this scope or pace. This study tested a living SLR framework, applied to an oncology indication, designed to maintain continuous multi-country evidence readiness and enable real-time PICO feasibility assessment for JCA and indirect treatment comparison (ITC) preparation.
METHODS: A living SLR was built with a broad scope capturing evidence requirements of each participating member state. The base review was refreshed quarterly and supplemented by ad-hoc updates triggered by predefined milestones (e.g., new trial readouts or comparator approvals). PICO simulation and feasibility analyses ran continuously against the live evidence base, surfaced through an interactive dashboard showing a real-time picture of evidence availability, comparator networks, and feasibility across candidate PICO scenarios. Human reviewers retained decision authority over which scenarios to advance.
RESULTS: In the oncology pilot, the framework converted SLR maintenance from a discrete project into a continuous capability, removing the multi-month restart typically needed once PICO scope is finalized. Because the evidence base stayed current and feasibility was assessed in real time, ITC analyses and JCA dossier sections were updated within 2-4 weeks of PICO finalization, versus several months conventionally. The dashboard let cross-functional teams weigh trade-offs across competing PICO scenarios as evidence evolved, with human decisions preserved at each gate. By compressing the evidence cycle, the approach returned an estimated 60-70 days to the team for strategic alignment ahead of submission.
CONCLUSIONS: A living SLR framework with real-time PICO simulation and human-in-the-loop decision-making transformed JCA readiness from a reactive effort into continuous preparedness in an oncology indication, freeing critical time for strategic alignment before submission and offering a scalable model for EU HTA evidence synthesis.
METHODS: A living SLR was built with a broad scope capturing evidence requirements of each participating member state. The base review was refreshed quarterly and supplemented by ad-hoc updates triggered by predefined milestones (e.g., new trial readouts or comparator approvals). PICO simulation and feasibility analyses ran continuously against the live evidence base, surfaced through an interactive dashboard showing a real-time picture of evidence availability, comparator networks, and feasibility across candidate PICO scenarios. Human reviewers retained decision authority over which scenarios to advance.
RESULTS: In the oncology pilot, the framework converted SLR maintenance from a discrete project into a continuous capability, removing the multi-month restart typically needed once PICO scope is finalized. Because the evidence base stayed current and feasibility was assessed in real time, ITC analyses and JCA dossier sections were updated within 2-4 weeks of PICO finalization, versus several months conventionally. The dashboard let cross-functional teams weigh trade-offs across competing PICO scenarios as evidence evolved, with human decisions preserved at each gate. By compressing the evidence cycle, the approach returned an estimated 60-70 days to the team for strategic alignment ahead of submission.
CONCLUSIONS: A living SLR framework with real-time PICO simulation and human-in-the-loop decision-making transformed JCA readiness from a reactive effort into continuous preparedness in an oncology indication, freeing critical time for strategic alignment before submission and offering a scalable model for EU HTA evidence synthesis.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
MSR3
Topic
Methodological & Statistical Research
Topic Subcategory
Artificial Intelligence, Machine Learning, Predictive Analytics
Disease
SDC: Oncology