The ten decisions. And why retrofitting is the expensive option.

Honestly, ‌I’ve ‌felt ‌good this week.

The repositioning actually stuck. And the talks that came after it? Different, in a way you notice right away. People show up already getting what we do, so we’re not burning half the call on background and definitions. We can move straight to the real issue on their side. That’s what it looks like when positioning does its job.

No personal update this week. Sometimes things just move, the work advances, and that’s plenty.

What I do have is this framework I’ve been piecing together in my head for a while, plus a story from last week that made the point almost too cleanly. I’ll start with the story.

EURORDIS ‌has ‌just ‌put out its scorecard for the EU’s very first Joint Clinical Assessment (JCA). The product in the spotlight was tovorafenib, a precision oncology therapy, and the JCA landed publicly on 28 July.

Final mark: C.

If you want the uncomfortable details, patient organisations split their ratings three ways. Document content came in at a C minus. Expert involvement also got a C minus. Structure, at least, scraped a B minus.

And no, this wasn’t a dress rehearsal. Not a draft, not a pilot, not a friendly trial run. This was the first proper, real-world JCA submission that patient organisations have assessed under the new EU HTA framework, the same framework every pharma company running a European programme now has to live with. The part that’s supposed to capture patient evidence, it hovered in the C minus band.

Here’s the catch baked into the system. Under the EU HTA Regulation, member states are required to take JCA conclusions into account when making national decisions. So a JCA that earns a C minus for patient content doesn’t fade away after publication. It follows the medicine into reimbursement talks in every EU market it needs to reach. It becomes the opening snapshot payers and HTA bodies carry around of the evidence base, and trying to patch that image later is, in practice, painfully difficult.

The Office of Health Economics added to the pile this week with its own look at what the tovorafenib JCA suggests for precision oncology assessment more generally. Their takeaway lines up neatly with EURORDIS: patient involvement is the weak spot right now. Not because the idea is impossible, but because sponsors didn’t put the evidence plumbing in place before submission, back when it still could have been built well.

None of this needs to be read as a swipe at any one company. It’s a design issue. And it’s the design issue this edition is circling.

Clinical ‌development ‌doesn’t ‌hinge on a single big call. It’s a chain of calls, one after another, and every time you guess wrong, you buy yourself a bill. You just don’t always see the invoice right away. It arrives later, dressed up as a protocol amendment, a messy JCA grade, an NHS procurement headache, or a NICE evidence review that politely asks questions your submission can’t answer.

Below are ten points where patient experience data either gets invited into the room or gets left outside. When it’s left out, the price tag doesn’t stay local, it spreads across the whole programme.

One: disease burden mapping. Before anyone types a line of protocol text, a decision is made about who this medicine is for, and what the supporting evidence looks like in those groups. If that mapping skips how the condition lands across communities split by ethnicity, deprivation, geography, and social determinants, the protocol starts life with a blind spot. And that blind spot pops up again and again in every later decision.

Two: eligibility criteria. Inclusion and exclusion rules decide who gets through the door. Most of the time they’re written without structured evidence on how those rules behave in the very communities carrying the most disease burden. So you end up with criteria tighter than the science needs, and conveniently aligned with excluding the populations regulators and payers are asking to see. Try to fix it mid-trial and you’re staring at a protocol amendment. The Tufts Center puts the average cost at £353,000 to £535,000, plus two to three extra months.

Three: visit schedule. Visit plans tend to be built around what’s easiest for sites, not what’s workable for patients juggling shift work, caring duties, patchy transport, and limited digital access. When the schedule doesn’t match real lives, dropout isn’t a surprise, it’s the default outcome. Then comes late-stage patching, and patching always costs more than doing it properly upfront.

Four: site selection. Where you place sites quietly decides who can realistically participate. A plan that clusters around big urban hospitals will serve some communities well, and miss others completely. The groups it misses are often the same ones the JCA, the MHRA Inclusion and Diversity Plan, and the NICE Evidence Standards Framework want accounted for. Trying to rethink site strategy after activation is slow, expensive, and rarely fun.

Five: endpoint and outcome selection. Trial outcomes are picked to meet regulatory expectations. Patient communities, the people who live with the condition and then the medicine, are seldom part of that design. So when HTA bodies ask whether endpoints mirror what matters to patients, now a JCA requirement, the honest answer is often “not really”, and there’s no organised evidence to defend the choices.

Six: patient-facing materials. Information sheets, consent forms, and participant communications usually come out of regulatory affairs, then get the legal treatment. In many programmes, they aren’t tested with the communities who actually receive them. The European Health Literacy Survey found nearly one in two Europeans has limited health literacy. Most consent forms are not written with that reality in mind.

Seven: consent process design. On paper, informed consent is a box you tick, legally documented and filed. Whether anyone truly understood what they agreed to is another matter, and the evidence base on comprehension has barely shifted in thirty years. Consent that fails on understanding is just retrofitting after the fact, only with higher stakes.

Eight: JCA evidence strategy. The Joint Clinical Assessment expects patient experience data that’s structured, systematic, and clearly tied to how the evidence package was built. The first JCA submission scored C minus on this. If sponsors wait until submission stage to assemble that evidence, instead of building it into design, they end up answering patient involvement questions with little more than retrospective consultation.

Nine: post-market surveillance design. After approval, the post-market surveillance plan dictates what ongoing data you’ll collect. EUDAMED now requires the Vigilance and Post-Market Surveillance module to feed a continuing lifecycle process. If key prescribing populations weren’t in the trial, and the surveillance plan wasn’t built to capture their experience, PMS evidence won’t match real-world use. That gap turns into both regulatory exposure and commercial risk.

Ten: patient involvement governance. Who’s involved, how they’re involved, when they’re involved, and whether they can actually change decisions. Most programmes can answer the first two, and go quiet on the last two. Involvement without influence is tokenism, full stop, and it’s exactly the pattern reflected in EURORDIS’s grade C.

Once these decisions are locked, you don’t get to rewind them. The patient experience evidence that could have nudged each one in the right direction costs a fraction of what comes later, the amendment, the JCA downgrade, the procurement challenge, or the PMS hole you’re left trying to explain.

To see where your programme sits across these ten decisions, the Regulatory Readiness Scorecard is the quickest check. Twenty questions. Fifteen minutes. Free.

Take the Regulatory Readiness Scorecard.

Now ‌Written: ‌Live ‌took a breather last week. This Wednesday, we’re back, and I’ve been circling this one on the calendar, it’s the conversation in the series I’ve wanted to have most.

Connie Lee Montgomery is living with Factor Seven Deficiency, Pemphigus Vulgaris, plus three other chronic conditions. And for thirty years she lived with symptoms that were obvious, tangible, and still waved off, again and again, by the healthcare system. A car accident, of all things, is what finally pushed her to a diagnosis. Later, she learned something that should make any clinician wince: every single person in her immediate family carries rare bleeding disorders.

All four. Missed.

Still, this episode isn’t just a medical timeline, not a neat little “then we figured it out” arc. It’s also about lineage, and the place she comes from. Connie identifies with Gullah Geechee culture, a community of enslaved Africans brought to the southeastern coast of the United States, people whose first encounter with Western medicine came as a public inspection on an auction block. That isn’t a sidebar to the story. It’s a core piece of why the trust gap between underserved communities and clinical research exists right now, and why it won’t be fixed with a shinier pamphlet and a friendlier headline.

We’ll get into what three decades of dismissal actually does to a person. We’ll also talk about how the pharma industry’s usual explanation for why Black communities distrust clinical research barely grazes the real issue. And we’ll dig into what HOT communication, Honest, Open, and Transparent, looks like when it’s lived out in practice, not just printed in a mission statement.

Connie is a retired occupational therapist, a global patient advocate, and the CEO and Founder of The Rare Cares Collective. She’s one of the most essential voices in this space, and I have a feeling this conversation is going to stick with a lot of people long after they watch.

Wednesday 5 August. 2pm UK. 9am ET.

Pharmaphorum ‌ran ‌a ‌piece this week that does something refreshingly unromantic, it puts numbers on what happens when patient input is baked into clinical development instead of stapled on at the end. Look across the programmes they tracked and you get a 17% improvement in cycle time. The budget story is even less subtle, impact ranged from a 3% increase to a 28% decrease. No wishful thinking here, these were real outcomes from teams that already had the patient evidence plumbing in place before anyone started locking in design choices.

Which flips the usual retrofitting logic on its head. Put the structure in early and you save. Try to bolt it on later and you pay for the privilege.

Servier, also this week, put their own numbers on the table: 68% of clinical trial protocols got patient feedback while still in development, and every single lay summary, 100%, went past patients for approval before it was used. That is not just “nice practice”, it is a public line in the sand, and it is quickly becoming part of the competitive baseline. Sponsors that cannot show something comparable should get comfortable with sharper, more direct questions from JCA reviewers, NICE, and NHS procurement.

Meanwhile, the NIHR IBHO BioResource kicked off at Sheffield Teaching Hospitals, starting with 7,000 participants from the Black community, around a third living with sickle cell disease. This is what a structured, community-rooted participant pool looks like, and it is exactly the sort of thing that can change what disciplined PPI methods actually deliver. The open question is simple enough: will sponsors match that level of investment with evidence designs that are capable of making proper use of it.

Sources: Pharmaphorum, July 2026. Servier patient engagement disclosures, July 2026. EURORDIS JCA assessment, July 2026. NIHR IBHO BioResource launch, July 2026. Office of Health Economics JCA analysis, July 2026.

The Equity Engine platform exists to give you structured, community-sourced patient experience data at the point where those decisions are still changeable. Fixed scope. Fixed duration. Fixed price.

Three ways in depending on where you are.

The Regulatory Readiness Scorecard is free. It tells you which of the ten decisions are your current exposure and what the specific fix looks like.

The Navigate the System toolkits cover six European markets in depth. If you are designing a programme that will need to hold up across Germany, France, Italy, Spain, the Netherlands, and the UK, the country-by-country evidence standards are in a format you can use at the design stage, not just the submission stage.

If you want a conversation about what a fixed-scope patient evidence engagement would look like for your specific programme, reply to this email. That is where it starts.

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.

Speak soon,

Ashish