Population Intervention Comparator Outcome

Expert-led, AI-enabled approach to help navigate the PICO maze for a successful JCA

  • Predicting the HTA needs of multiple countries early in development allows for clear evidence strategy and design

  • Integrating AI into this process allows the outputs to remain contemporary as the wider landscape changes and ensures speed, efficiency and accuracy

  • PICO Predict is AI enabled, but human designed. Leveraging the expertise of Decisive Consulting we ensure that every output is fit for purpose and clearly explained

The time is now

The Joint Clinical Assessment (JCA) according to Regulation (EU) 2021/2282 (EU HTA) will initially be implemented for oncology drugs and ATMPs from January 2025 with a full roll-out by 2030.

All JCA procedures will begin with a scoping process leading to the development of a country-specific research question, represented as individual PICO schemes.

Patient population, intervention, comparator, and study endpoints to measure the outcome are determined by each authority as the basis for clinical evaluation.

Given the diversity of standards of care and availability of medicines across Europe, multiple PICOs can be expected. By simulating an EU HTA-based scoping process early in development we aim to improve evidence planning and anticipate and manage complexity.

Engaging at any stage through development PICO PREDICT will allow teams to dynamically anticipate the PICO statement for individual countries and plan to meet diverging needs.

Using AI technology allows us to automate key aspects of this process and to replicate them on demand - enabling truly dynamic assessment efficiently and quickly as the environment and evidence evolve.

Combining this with a global expert network for validation and the ability to formulate and deliver SLR protocols swiftly and accurately PICO PREDICT will ensure companies are optimally prepared for HTA around the world.

Get in Touch

We’ll be delighted to talk more about the promise of PICO Predict and our wider consulting services. Don’t forget to specify a preferred method of contact.