The IDP conversation I keep having. And England are in the quarter finals.

Right, before we get into anything clinical trials related, can we just appreciate what England did overnight?

I will be honest, I came into this World Cup managing expectations carefully. Years of heartbreak will do that to you. But that game against Mexico was something else. I watched most of it through my fingers and came out the other side genuinely believing. Quarter finals. England versus Norway on Saturday. I am cautiously, nervously, superstitiously excited.

Right. Back to work.

Here is how it usually goes.

Someone senior says the words. We take diversity seriously. We are committed to inclusion. We have an IDP. And then you look at the IDP and it says something like: we will ensure our recruitment materials are accessible, we will consider community engagement, we will monitor representation throughout the study.

That is not a plan. That is a collection of intentions with no mechanism behind them.

The UK's new clinical trials framework came into force in April. The expectation that studies will have a credible Inclusion and Diversity Plan is now baked into how they get reviewed. But the expectation arrived before the infrastructure to meet it existed in most organisations. So sponsors are producing documents that tick a box without being able to answer the questions those documents are supposed to answer.

I want to be clear about the language, because I have already seen this misreported. IDPs are strongly expected, not a legal mandate. But strongly expected, attached to a review process that shapes whether your study gets approved, is not optional. And if you are designing protocols that will be submitted in the next twelve to eighteen months, the question will be in front of you. The question is whether you have an honest answer.

Four questions sit at the heart of any credible IDP.

The first is: who actually carries the burden of this disease, and are they in your protocol? Not who you would like to recruit. Who the epidemiology tells you must be in the data for the evidence to be valid. For conditions like type 2 diabetes, cardiovascular disease, certain cancers, the burden falls disproportionately on communities consistently underrepresented in trials. If your IDP does not start with that picture, it is a preference statement, not a plan.

The second is: what are the specific barriers for those communities in this study? Not the generic list that gets copied from the last submission. The specific ones, for this condition, in this population, in the regions where you plan to site the study. Visit burden. Shift work. Caring responsibilities. Language. Distance to site. Trust. In our platform we can show you exactly how these barriers cluster for specific communities in specific geographies. Most sponsors are working from assumptions.

The third is: what did you actually change in the protocol because of what you found? This is the one that separates an IDP from a piece of paper. Did the eligibility criteria get reviewed against the lived reality of the target population before they were locked? Did the visit schedule get mapped against real working patterns? Did anyone look at the proposed sites and ask whether the communities you need are anywhere near them?

The fourth is: how will you know whether it worked? Recruitment by ethnicity is the floor, not the ceiling. The maturing expectation will ask whether underrepresented participants completed the study at the same rate, whether dropout correlated with the barriers you said you had addressed. Most monitoring frameworks are not set up to answer that.

I keep having this conversation and hitting the same wall. Not resistance. Genuine lack of infrastructure. The teams care. The systems do not yet exist to do what caring requires.

Later this week I am publishing a free plain-English explainer that breaks down exactly what the IDP framework requires, the questions, the evidence standard, and where the gaps typically are. Here is a taster of what is inside:

The IDP is not a diversity statement. It is a structured account of how a specific clinical trial was designed to be accessible to the populations it needs to reach. It asks four things: who does this trial need to include, what are the specific barriers for those populations, what did you change because of what you found, and how will you measure whether it worked. Most sponsors can answer the first question partially. Very few can answer the second and third with evidence rather than intention. Almost none have a monitoring framework that answers the fourth.

Going live later this week. Watch this space.

Something worth knowing if you are new here.

We have three toolkits available at unwritten.health/toolkits, and I want to share something that a clinical development lead told me last week that stuck with me.

He is a lead working on a global trial. He picked up the European Patient Evidence Navigator partly out of professional curiosity. His feedback was this: when you are working across multiple countries on a global programme, you do not always have visibility into what the local regulatory and HTA environment actually requires. Those blind spots are expensive. The navigator closed one he did not fully know he had.

That is exactly what it was built for. Six European markets covered in depth, with the 2025 to 2026 regulatory changes that matter. AMNOG. JCA. LFSS Article 65. AIFA reform. Country by country evidence standards in a format you can actually use.

If you are preparing a submission, briefing an agency, or designing a trial that will need to hold up across multiple markets, it is worth an hour of your time.

Three toolkits available individually or as a bundle. Instant download.

I am genuinely looking forward to this one.

Dr Lisa Kerr is Head of Patient Engagement at Evinova, and before that held senior roles at AstraZeneca. She has been inside the machine. She has sat in global team meetings where real patient data flagged mental health as a significant comorbidity and watched the decision get made to set it aside because it complicated the molecule story. She knows exactly why that happens. She also knows what it costs.

What makes Lisa different from most senior people in this space is that she is not speaking theoretically. She navigates mental health personally. She has supported her son Rory through his own journey with the healthcare system. That combination of inside knowledge and personal stake is what makes these conversations worth having.

We are going to talk about mental health as a missing comorbidity in clinical trial design. About what gets measured and what gets deliberately left out. About what it would actually look like to design for the whole patient, not just the target condition.

She founded Safe Space, AstraZeneca's mental health employee resource group, and co-chairs the Inclusion and Diversity Network at Evinova. She is building something from inside one of the biggest players in this space that most people in her position would not have the nerve to attempt.

Wednesday 8 July. 2pm UK. 9am ET. Now Written: Live.

Thanks for reading. This newsletter exists because I believe the right framing, in the right hands, changes decisions. If it did that for you this week, even a little, that is enough.

Ashish.