What will your evidence leave undecided?
Before committing to a development programme, it is worth asking which decisions the resulting evidence will allow others to make.
A study can answer an important scientific question while leaving a clinician, an assessor or a healthcare organization with a different question unresolved. Understanding that distinction early can influence the programme’s design, the markets it can credibly address and the investment required after the initial results arrive.
Evidence investment should be judged by the decisions it enables and the consequential uncertainties it leaves unresolved.
The European Union’s current Joint Scientific Consultation window offers a timely example. Open from 23 September to 21 October 2026, it gives eligible health-technology developers an opportunity to seek advice on evidence needs for a subsequent joint clinical assessment while studies are still being planned. The opportunity covers medicines and selected categories of medical devices and in vitro diagnostics. HaDEA announcement.
The consultation does not guarantee a favourable assessment or reimbursement. Its outcome is non-binding and does not predetermine a later joint clinical assessment. That boundary matters: advice can inform a development choice while uncertainty remains. EU HTA Regulation, Article 16.
The broader strategic question extends beyond participation in this particular process. What does an organization need to understand before it commits to generating evidence that may take substantial time and resources to produce?
Consider a hypothetical diagnostic innovation intended to inform an earlier treatment decision. A study might establish its performance under defined conditions. A clinician considering its use could still need to understand how the result would change care. A hospital could need to assess whether that change is feasible within its services. A payer could ask what additional benefit would justify funding it.
These questions are connected, but they are not interchangeable. Answering one does not automatically answer the others.
For the developer, the implication is practical. If the intended use depends on a particular clinical decision, that decision deserves attention when the evidence plan is being shaped. Leaving it unresolved may be a reasonable choice at an early stage. It becomes more consequential if the commercial plan already assumes that clinicians will act on the result.
This is where evidence planning becomes a leadership responsibility.
Scientific teams need to protect the validity of the questions and methods. Market-access colleagues can help clarify assessment needs. Commercial teams can contribute an understanding of intended users and the circumstances in which they would consider changing practice. Together, these perspectives can expose assumptions that would otherwise remain inside separate plans.
Senior leadership then has to decide what to do with the gaps. Some may warrant changing the study. Others may require a separate investigation, a narrower initial market or a later investment. The value of cross-functional discussion lies in making those choices explicit.
There is a cost to seeking more evidence. Additional populations, comparators, outcomes or follow-up can increase complexity, extend timelines and consume resources that could support other programmes. Attempting to answer every possible future question can make a development plan unmanageable.
The objective is to identify which uncertainties matter most to the next commitment.
One useful distinction is between uncertainty that could change the direction of a programme and uncertainty that can reasonably be addressed as the programme progresses. If a missing answer could undermine the intended use or the case for entering a market, it deserves a different discussion from a question that would refine an already credible route forward.
That distinction also helps clarify responsibility. An acknowledged gap should have an owner, a consequence and a point at which it will be reconsidered. Otherwise, it can remain visible in technical discussions while disappearing from forecasts and investment assumptions.
For an executive committee or board, this suggests a more specific review of evidence plans. Alongside scientific milestones, ask which external decisions those milestones are expected to support. Where support remains uncertain, examine what the investment case assumes will happen.
A programme may still merit funding. The choice could be to invest in learning, preserve a future option or proceed within a narrower scope. Each can be defensible when the purpose of the commitment is clear.
The same discipline applies beyond the EU consultation process. Different technologies and health systems require different evidence, but leaders still need to understand the relationship between what they plan to demonstrate and what others will need to decide.
By the time an organization asks customers or health systems to adopt an innovation, many of the choices shaping its evidence have already been made. Bringing those future decisions into the investment discussion earlier gives leaders a clearer view of what they are funding—and of the uncertainties they are choosing to carry.
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