How many PICOs will your oncology product face — and how to prepare

Dr. ETH Sanja Fitzgerald

Sur Access · November 2026


Two years ago, the question about Europe’s Joint Clinical Assessment (JCA) was “what is it?” JCA has applied to new oncology medicines and ATMPs since January 2025, the first assessment reports are now public, and the framework expands to orphan medicines in 2028 and all new medicines in 2030.


Today's question is sharper, and it is the one that actually decides your outcome: how many separate evidence questions will Europe ask of your single development programme — and can that programme answer them?


How the scope is really set

It helps to be precise about the process, because a lot of early commentary got it slightly wrong.


When you submit your marketing-authorisation application to the EMA, the JCA scoping process begins in parallel. The HTA bodies of the Member States — not the national medicines regulators — submit the PICO questions that matter to them: the populations, comparators and outcomes their systems care about. The Coordination Group (HTACG) then consolidates those national inputs into one final assessment scope.


Here is the part that catches developers out: you don’t hunt for your PICOs. They are handed to you — late, and on a clock. You receive the consolidated scope roughly 40 days after filing, and from that point you have about 100 days (60 for products on accelerated EMA review) to produce a complete JCA dossier answering every PICO in it. That is not the time to start building indirect comparisons.


So how many PICOs, really?

Enough to cause what people only half-jokingly call “PICO anxiety.” For a complex oncology product, the consolidated scope can run to 10–30 distinct PICOs. The first published reports make it concrete: tovorafenib’s scope contained eight PICOs; tarlatamab’s, seven, spread across four different patient populations — all from a single pivotal trial each.


But, a high PICO count does not mean you need that many clinical trials. It means one trial has to be designed to feed many answers.


And the numbers are now under scrutiny from the system itself. One year in, PICO proliferation is widely judged inefficient — for the assessors as much as for the developers — and the Coordination Group has begun running scoping-optimisation exercises to consolidate and trim the counts. The methodology will tighten, and the worst-case numbers may well come down. What will not change is that you do not control your own scope — so you still design for the range of questions you could plausibly face, while watching how the consolidation rules evolve.


How to be ready without running ten trials

Three levers do most of the work:

Strategic trial design. A single well-designed trial — multi-arm where feasible, with pre-specified subgroups and a sensible endpoint hierarchy — can supply evidence for several PICOs at once. The operative word is pre-specified: subgroups invented after the data are in will be treated as exploratory and discounted.


Evidence synthesis, planned in advance. Where you have no head-to-head data, indirect treatment comparisons and network meta-analyses can bridge the gap — but only if they are built before the PICOs land, on anticipated scenarios. The first reports show what happens otherwise: tovorafenib’s one indirect comparison rested on an effective sample size of fewer than six patients and could not support a conclusion. Reconstructed evidence does not survive the assessors.


Prioritisation. Not every PICO carries equal commercial weight. Identify the ones that will actually drive the national funding decisions that follow JCA, and resource those first.


What to do now

  • Start at the Phase 2-to-3 transition, not at filing. By the time the scope arrives, the decisions that determine your evidence — comparator, population, endpoints, statistical plan — were made years earlier.
  • Shadow your PICOs early and use the Joint Scientific Consultation to align your trial design with what Europe is likely to ask, before Phase 3 opens.
  • Keep your eye on the national finish line. JCA produces a shared clinical assessment — but price, reimbursement and added-benefit decisions stay firmly national. A technically compliant dossier is not the goal; an evidence strategy that still works in the markets where access and price are decided is.

The honest version of “PICO anxiety” isn’t about the number. It’s about whether the evidence you are generating right now can answer the questions Europe is going to ask.


That is the work I do. See how Sur Access makes a development programme JCA-ready!


EU HTA & JCA