The visit schedule nobody designed for you

I launched Frequency of Exclusion on World Clinical Trials Day last week. 1,200 people's lived experience, turned into structured evidence about what actually stops underserved communities from participating in clinical research, in the UK. The most honest account of the exclusion problem I have been able to produce.

And then I sat online refreshing my feeds all day, waiting for feedback.

Building in public means sharing the moments that don't feel triumphant alongside the ones that do. Wednesday was both of those things at once. The work is real. The data is real. The launch happened. And the silence that follows something you have poured yourself into is its own particular kind of hard.

I have been here before. The Demand Diversity campaign in 2020 launched into a world mid-lockdown, five days before George Floyd was killed, and felt like it landed in a void. And then slowly, then quickly, the conversations started. The people who needed to hear it found it. The work mattered, even when the metrics didn't immediately say so. But this was a different time.

If you downloaded the report and haven't yet shared it with someone who needs it, this is me asking you directly. Not for the numbers. Because the communities who gave us their data deserve for it to reach the people with the power to act on it. Send it to the person in your organisation who is currently designing a protocol. Forward this email to the clinical operations leader who is wondering why their sites are underperforming. Put it in front of the medical affairs team building their patient engagement strategy for next year.

The report is here.

Let me use this edition to go deep on one finding from Frequency of Exclusion. Because I think it deserves more space than a report executive summary can give it.

The single most common barrier to clinical trial participation across our entire dataset is not distrust of the pharmaceutical industry. It is not fear of side effects. It is not lack of awareness that trials exist.

It is too many hospital visits.

The visit burden finding does not appear in isolation. It clusters. The respondents who selected too many hospital visits as a barrier were overwhelmingly the same respondents who also reported caring responsibilities, inflexible work patterns, transport difficulties, and limited digital access. These are not separate problems that happen to coexist. They are the lived reality of the same people, compounding each other in ways that make participation not just inconvenient but genuinely impossible.

And here is the part that stayed with me longest. A meaningful group in our dataset had positive prior experiences of clinical trials. They believed in research. They said they would take part again. They still reported being structurally blocked by the same visit burden, the same caring responsibilities, the same transport constraints.

These are not sceptics. They are not hard to reach. They are people who want to participate and cannot, because the protocol was not designed with their lives in mind.

That distinction matters enormously. Because the industry's default response to low participation from underserved communities is to invest in outreach. More community events. More targeted communications. More patient-facing materials. But you cannot communicate your way around a visit schedule that requires someone to take three days off work they cannot afford to take, arrange childcare they cannot easily arrange, and travel to a hospital site that is not on their route.

The outreach finds them. The protocol loses them. And the industry files it under recruitment failure.

What the visit burden finding is actually telling protocol designers is this: before you ask how to reach these communities, ask whether your design gives them a realistic chance of saying yes. That question has to be answered upstream, before the protocol is locked, when the visit schedule is still flexible, when the site strategy is still being set, when the eligibility criteria are still being written.

Once those decisions are made, the visit burden is baked in. And no amount of recruitment spend will unbake it.

This is precisely the moment Unwritten Health's community data is built to inform. Not after activation, when the response options are expensive. Before design lock, when the right evidence can change the shape of the protocol rather than just the messaging around it.

The report is here.

Alongside the report this week, I published a video that I think provides important context for clinical development teams who want to understand why this is no longer just an ethical argument.

It is called: Why regulators now expect patient experience in your clinical plan.

Here is the short version. The EMA's 2024 reflection paper on patient experience data is shifting the question regulators ask. It used to be: did you talk to patients? The question now is: can you show how patient experience evidence shaped what you did? Endpoints. Benefit-risk. Visit schedule. Procedures. The expectation is a clear chain from evidence to decision, not a qualitative add-on filed somewhere in the background.

At the same time, ICH's draft E22 guideline is moving patient preference studies from fuzzy qualitative exercises into structured, documented evidence. When patient preferences could influence benefit-risk, regulators now expect you to treat a preference study with the same rigour as any other study in your plan.

And here is the gap that both frameworks expose: most patient input still comes from people who are easy to reach. Patient groups. Online communities. People who already know their way around the system. The people who struggle most to access clinical trials, those in more deprived areas, minoritised ethnic groups, people with insecure work or housing, rarely appear in development plans in any structured way.

Yet these are exactly the populations regulators and payers are increasingly asking about. Can these patients realistically take part in this protocol? Will they experience benefits and risks in the same way as your current trial population? If the honest answer is we don't really know, that is becoming a scientific risk and a regulatory risk, not just a health equity issue.

The video is twelve minutes. It is the clearest explanation I have produced of where the regulatory direction of travel is heading and what it means for how you build your clinical development plan.

Watch it on YouTube.

On Sunday I was at an ayurvedic medicine conference. I want to sit with how strange that sentence feels coming from someone who has spent twenty years inside clinical development.

I went with a friend. She is a qualified health coach and one of the most thoughtful people I know on the relationship between wellbeing, prevention, and what medicine is actually for. Her father died young. So did mine. We have that grief in common, the particular kind that comes from watching a parent navigate a system that wasn't built around them, that didn't catch things early enough, that moved too slowly when it finally did.

Same loss. Different conclusions.

She moved toward prevention, toward wellness, toward understanding the body before it breaks down. I moved toward clinical research, toward data infrastructure, toward fixing the system from inside the evidence base. We ended up in the same room on Sunday approaching the same questions from completely opposite directions.

What struck me most was not the ayurvedic practice itself, though I found it genuinely interesting, particularly the sessions with oncologists on the agenda. What struck me was the question underneath everything being discussed: at what point does someone enter western medicine? And who decides when that moment is?

Because the communities Unwritten Health works with are not absent from the healthcare system because they distrust medicine in principle. Many of them have rich traditions of managing health that predate the NHS by centuries. Ayurvedic practice. Traditional Chinese medicine. Herbal approaches passed down through families. These are not signs of ignorance. They are signs of a relationship with the body and with healing that the clinical research industry has never taken seriously as data.

And here is the question I keep turning over: is that a coincidence?

The communities most likely to draw on traditional or complementary medicine are the same communities most underrepresented in clinical trials. The same communities whose disease burden is highest. The same communities whose lived experience our industry has spent decades failing to capture.

I am not arguing that ayurvedic medicine should replace oncology. I am not arguing against evidence-based medicine. I have dedicated my career to strengthening the evidence base, specifically by making it more representative of the people it is supposed to serve.

But I am asking whether the clinical research industry's almost total lack of engagement with preventative and wellness approaches is itself an equity problem. Because the people who can access functional medicine, health coaching, longevity clinics, and preventative screening are largely the people who already have the best health outcomes. The people who cannot access those things are the people who show up in our disease burden data.

We have built an industry that is extraordinarily good at treating conditions after they have developed and extraordinarily uninterested in the upstream question of why certain communities develop those conditions at higher rates, at younger ages, and with less access to the interventions that might have caught things earlier.

My dad was 52 when he was diagnosed. My friend's father was young too. Both of them were let down not just at the point of treatment but at every point before it. The system did not see them coming.

I do not know exactly where I land on the relationship between traditional medicine and clinical research. Sunday gave me more questions than answers. But I left thinking that an industry serious about health equity cannot keep treating prevention and wellness as someone else's problem. The communities we are trying to reach are already making decisions about their health in spaces the industry has never looked. And until we treat that as data worth understanding, we will keep arriving too late.

I have been building something else alongside the report. And now I am ready to talk about it.

Now ritten: Live is a new interview series launching June 17th. Every Wednesday. 2pm UK. 9am ET.

The name tells you what it is. The stories that go unwritten are now being written. The voices that don't make it into the evidence base. The lived experiences that the system was not designed to capture and that clinical research has been making decisions without for decades.

I am sitting down with three guests to start.

Ella Balasa. A patient advocate living with cystic fibrosis who has spent years working on clinical trial access and eligibility. We are going to talk about the eligibility criteria that quietly close the door on the patients who most need access to new treatments, and what it would look like to design those criteria differently.

Lisa Kerr. A mental health advocate whose story cuts right to the heart of what the diagnosis journey looks like when the system is not built around you. We are going to talk about what it means to navigate mental healthcare as someone the system keeps misreading, and what that experience should be teaching clinical researchers.

Sahara Fleetwood-Beresford. Whose journey to diagnosis took years longer than it should have. We are going to talk about what gets lost in that time, and why the long diagnosis journey is one of the most underexamined equity problems in clinical research.

These are not polished panel conversations. They are the kind of conversations that usually only happen off the record. I am putting them on the record.

Follow me on LinkedIn for the first guest announcement this week. Every Wednesday. June 17th. 2pm UK. 9am ET..

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.