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Unwritten Dispatches may have been on hiatus through out April. However, the work of building Unwritten Health continued.

April was the kind of month I will look back on as one of the most important in building this company. Investor conversations that required real preparation. Not decks. Actual preparation. Pilot work deepening with partners who are starting to ask harder, better questions. Commercial conversations moving in the right direction that needed careful attention at exactly the right moment.

The kind of month where writing the newsletter had to wait because everything else couldn't.

I did miss this though.

Across April I have been building arguments I want to share properly, with the people who have been reading this from the start. Results are coming through that matter. Things are happening in this industry that need to be said clearly. There is a case study landing in the next few weeks that I think will be the most concrete thing we have published.

So. I am back. And there's a lot to get into.

A pharma leader said something to me last week that I haven't been able to move past.

We were in a meeting. Nice building, just off the M4 corridor. The conversation turned to clinical trial inclusivity. And the leader said, with genuine conviction, that the reason underserved communities are not represented in the data, is that the industry hasn't communicated the benefits clearly enough. Better messaging. More targeted outreach. Stronger relationships with community spokespeople. Get those three things right, he said, and the participation problem solves itself.

I didn't argue. Not in that room.

But I've been thinking about it since. Because he wasn't being cynical. He believed it. He had probably built a career making exactly that kind of communications work land. And that belief, held sincerely by a lot of very capable people across this industry, is the single biggest reason this problem keeps not getting solved.

So this edition is my full answer. The one I didn't give in the room.

The comms framing isn't just wrong. It's comfortable. And that's the problem.

Here's what happens when you treat clinical trial inclusivity as a communications problem.

You generate activity. Outreach campaigns. Patient-facing materials. Advisory boards. Community engagement events. All of it visible. All of it measurable. All of it presentable in a governance meeting as evidence that the organisation takes this seriously.

The protocol doesn't change. The eligibility criteria don't change. The visit schedule doesn't change. The communities being missed are still being missed. Nothing about the design was built to reach them.

But the dashboard looks good.

When you treat it as an infrastructure problem, the work happens upstream and it's harder to show in the short term. You build evidence about how real people live with the condition before the protocol is locked. You stress-test eligibility criteria against the lives of the communities who carry the highest disease burden. You map visit schedules against real shift patterns, transport access, caring responsibilities. You let that evidence shape the design before the design shapes everything else.

One approach generates activity. The other generates representation.

The reason the first keeps winning is straightforward. Activity is easier to defend in a quarterly review. Infrastructure is an investment whose returns show up in recruitment timelines and amendment rates, not in engagement dashboards.

That is the structural incentive this field has built. And it will not shift until the people commissioning the work start asking different questions

I want to show you what happens when the right questions get asked early enough.

Earlier this year, a small to mid-size biotech came to us. Phase II study. Timelines, as ever, were tight.

We came in before protocol lock. Before the site list was set. That timing matters more than anything else I'm about to tell you.

Three things shaped what we did.

We stress-tested the eligibility criteria against how people in the relevant communities actually live with the condition. Several of those criteria would have excluded far more patients than the science required. They were drawn more tightly than the clinical rationale demanded, and they happened to cut hardest against the populations the study most needed to reach. This is not unusual. It is what happens when protocol design happens without community intelligence in the room.

We mapped the visit schedule against real working patterns, caring responsibilities, transport access, and digital connectivity. There were points in the schedule where the protocol was setting itself up for avoidable dropouts. The procedures weren't unreasonable in isolation. They had just been sequenced without any model of how the people expected to complete them actually organise their lives.

We looked at the site strategy and flagged where a heavy reliance on hospital sites would structurally miss the patients the trial needed to reach. A community mix was going to perform better. Not marginally. Materially.

The client is now on track to start their study in six months. The comparable baseline for a study of this type is nine to twelve months. Two to four months recovered before a single patient has been recruited.

For a typical Phase II or Phase III study, two to four months is worth between $2.4 million and $4.8 million in direct operating savings. That is before the commercial value of earlier market entry. And if the upfront work prevents even one major feasibility-driven amendment, that is another $300,000 to $500,000 saved and another two to three months returned.

This is what community insight actually delivers. Not a CSR slide. Real time. Real money. Real patients reached sooner.

The full case study is coming in the next few weeks. I'll share it here first.

Here is the part I don't usually say out loud.

Building a company with a strong mission means you get tested on it constantly. Not occasionally. Constantly.

Every conversation with a potential customer is an invitation to soften the argument so the sale closes faster. Every conversation with a potential investor is an invitation to broaden the market so the round looks bigger. Every conversation with a peer is an invitation to make the framing more comfortable so the room agrees.

Each of those invitations is reasonable. None of them is free.

When you describe inclusivity as a data infrastructure problem to someone who has spent three years defending their communications strategy, you are not just making an argument. You are implicitly questioning decisions they have already made and been rewarded for. That creates friction. Friction slows things down.

The temptation is to find language that gets to the same place without the same friction. To make the argument in a way that doesn't require anyone in the room to feel implicated in the problem.

I understand that temptation. I have felt it.

But the companies I respect most are the ones that held their argument when softening it would have been easier. They understood that the strength of their position was the thing that made them defensible. You can copy a product feature. You can replicate a methodology. You cannot replicate the decision to hold your ground when the room is asking you to move.

Conviction is expensive in the short term. It is what you have left when everything else gets copied.

So here is where that leaves us.

The communications framing persists because it generates visible activity without requiring anyone to change how protocols get designed.

Holding a different position creates friction before it creates results.

And the results, when they come, look like the case study above. Months recovered. Costs avoided. Communities reached who would otherwise have been excluded before the trial began.

The hard thing about building infrastructure is that it doesn't produce metrics in the quarter you build it. It produces them in the quarter your recruitment opens. That gap between investment and return is where most organisations lose their nerve.

The ones that hold through it get results like those above.

The ones that retreat back to the communications framing are still wondering, twelve months into recruitment, why their sites are underperforming.

I know which side of that I'm building on.

This week in data

Each protocol amendment in a Phase II or Phase III clinical trial costs between $300,000 and $500,000 in direct expenses and adds two to three months to the development timeline on average. The majority of amendments are driven by recruitment failure or eligibility issues that were foreseeable at the design stage.

Tufts Center for the Study of Drug Development. Impact Report. Various editions. tufts-csdd.org

Foreseeable. Not inevitable. Foreseeable. The distinction matters because foreseeable problems have solutions. They just require the right data to be in the room before the protocol is locked.

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's enough.

Ashish.

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