Advisory
Patient input, early enough to change something
I review clinical trial designs before the protocol locks, and identify where the evidence you are about to generate will not carry the patients, or the payers, you need it to carry.
Access constraints are usually written into the protocol
Reimbursement conversations tend to expose problems that were created years earlier, at design stage, and that are no longer economical to fix.
An endpoint is selected because it is validated and easy to administer, not because it detects the changes patients report as most meaningful. A subgroup is left out of the design because it is harder to recruit or harder to measure, and is later left outside reimbursement because the evidence for it does not exist. An eligibility boundary set for operational reasons becomes, in effect, the boundary of access.
None of these are unusual, and none of them look like errors at the time. They look like reasonable protocol decisions. They only become access problems later, when the file is assembled and the questions arrive.
The period before protocol lock is the only point at which these are cheap to address. It is also short.
The access-gap audit
A structured review of a trial design, carried out before the protocol is final, reading the design through two lenses at once. The patient who will live inside the study, and the payer who will later assess it, with particular attention to strict European markets such as the Netherlands and the Nordics.
The review examines three areas.
Endpoint sensitivity
Whether your outcome measures can detect the changes that matter to patients, and where meaningful benefit is likely to go unrecorded.
Population and eligibility
Where your criteria are likely to translate, downstream, into groups excluded from access, and which of those exclusions are avoidable.
Evidence and the payer
Whether the dataset you are on course to generate answers the questions a strict payer will ask, and where it will be thin.
Does this slow the study down
No, and I understand why it is the first thing asked.
Patient involvement gets a reputation for adding time because it is often introduced late, unstructured, and without any sense of what is actually still changeable. Introduced early, and scoped, it does the opposite. The delays in this field come from what was not caught, not from what was.
I am also not going to hand you an idealised list. You have timelines, a regulator, a budget and internal constraints I will not always see. A recommendation that ignores those is not advice. I am interested in the version that survives contact with your organisation, so the output is deliberately prioritised, and I will tell you which findings I think you can safely leave alone.
Other advisory work
Endpoint and outcome measure selection. Review of patient-facing documents, informed consent and study materials. Patient engagement strategy. Advisory boards. Access and reimbursement questions in strict European markets. Internal sessions for clinical and medical teams.
If the protocol is still open
Tell me roughly where you are in the process and what is still genuinely in discussion. A short call is usually enough to establish whether there is anything here worth pursuing.