26.06.2025

What to consider with a PICO proposal?

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With the PICO Proposal, the guideline took an important step forward — one that could greatly reduce the number of potential PICOs during EU HTA dossier strategy development.

⚙️ At the start of your EU HTA dossier strategy development you have to simulate the consolidated PICOs (WP2.2), resembling the methodology applied for by the JCA subgroup. Key input for the member states (i.e., your affiliates or their respective consultants) is the PICO proposal. This should follow a precise methodology.

This is how our template for the PICO proposal looks like:

📋 Executive Summary

📥️ Underlying information for PICO proposal:

🔹 Draft SmPC

🔹 Clinical overview

🔎 Evidence search (Search strategy, Data extraction):

🔹 Relevant EU guidelines

🔹 Alternative guidance documents

🔹 Clinical opinion

📑 Development of PICO proposal

Looking for a shortcut? Our working group here at Ecker-Ecker is happy to discuss with you details about what to put into the template and review it.

In case you are looking for a deep dive: Join our EU HTA summer school in two months in Hamburg (https://www.linkedin.com/posts/ecker-ecker_eu-hta-summer-school-activity-7335591133189709825-JSOb?utm_source=share&utm_medium=member_desktop&rcm=ACoAAAybN_EBaAwny817OR6ivVDOh7MeUZhDQf0)

This is the third part of our series "News from the EU HTA workshop". Providing you with insights from our current work on EU HTA. Previous parts can be found here:

        1st part: Use a real template - Link: https://www.linkedin.com/company/71660709/admin/page-posts/published/

         2nd part: How to do a PICO survey? - Link: https://www.linkedin.com/company/71660709/admin/page-posts/published/

More on how to prepare for EU HTA in our book: EU HTA 101

📖 Amazon (print): https://amzn.eu/d/6w1NGhn

💻 Amazon (e-book): https://amzn.eu/d/6aZogGH