Consent was a 34-page document signed after a rushed conversation. Comprehension studies showed patients could not recall the trial's randomisation or their right to withdraw - a documented ethical and regulatory exposure.
STUDY 26 / 30 · ANONYMISED · NDA · HEALTHCARE · MUNICH · MULTI-SITE
HEALTHCARE · MUNICH Informed consent that leaves the patient actually informed.
RoleLead designer + researcher
Timeline14 weeks
Team2 designers, 1 researcher, 1 PM, 2 frontend, 2 clinical SMEs
VerticalClinical trial platform · oncology sites across EU
Layered the consent so the structurally critical facts come first and are checked for comprehension, with the full document remaining complete and accessible throughout.
Comprehension on the critical items rose sharply. Withdrawal rates were unchanged, which was the safety question the ethics committee cared about most.
88%RANDOMISATION COMPREHENSIONfrom 34%
91%WITHDRAWAL-RIGHT RECALLfrom 41%
+6 minCONSENT CONVERSATION LENGTHaccepted by sites
THE ARGUMENT
Why the obvious solution was wrong.
The study matters because the product problem was reframed before the interface was polished.
A 34-page consent document satisfies a regulatory requirement and fails an ethical one. Patients being offered a trial at the worst moment of their lives are asked to absorb randomisation, placebo, blinding, withdrawal rights and adverse-event reporting in a single conversation, and comprehension studies consistently show they do not. The document is legally adequate and informationally inert, and everyone in the field knows it.
We layered it. Four things a patient must understand come first, in plain language, each with a short comprehension check that is a conversation prompt for the site staff rather than a test the patient can fail. The full document remains complete and reachable at every point - nothing was removed, and the regulator's requirement is met in full. Comprehension on randomisation went from 34% to 88%. Withdrawal rates did not change, which was the question the ethics committee asked first and the finding that let it approve.
THE INTERFACE CRAFT
The interaction, rendered as a working product surface.
The specimen below is code-native and uses the study's own design logic. The client interface remains protected.
HEALTHCARE
ALARM PRIORITYNeeds action
Room 408 · 02:14
DESIGN DECISIONS
Positions we would defend.
Each decision names the principle and the product consequence, not a stylistic preference.
Layer, never abridge
A shorter consent is a regulatory problem. A layered one is a comprehension solution that keeps the full document intact.
Check comprehension, do not test the patient
A failed check must route to a human conversation. A patient who feels tested at that moment will disengage from the trial.
Six extra minutes is the right price
Sites accepted a longer conversation once the comprehension data was shown. We measured and presented the trade rather than assuming it.
PRODUCT LEADER READOUT
What transfers, and what should remain specific to this product.
A case study is useful when its operating principle travels without turning the original interface into a template.
Read the operating condition
For Clinical trial platform · oncology sites across EU, the transferable lesson is not a copied screen. It is the condition the interface had to make legible: Randomisation, placebo possibility, withdrawal rights and adverse-event reporting, in plain language, before anything else. Rebuild that visibility for your own roles, risk, terminology, and operating cadence.
Protect the design rule
A shorter consent is a regulatory problem. A layered one is a comprehension solution that keeps the full document intact. Keep that rule in the acceptance criteria, component states, and production QA record so later visual cleanup cannot erase why the interaction exists.
Measure behaviour after ship
The evidence record is 88% for randomisation comprehension, from 34%. Recreate the baseline and outcome window before rollout, segment the result by role and context, and state clearly what the measure cannot prove.
RESEARCH RECORD
The work behind the interface.
These artefacts connect the final interaction back to the evidence and product model that produced it.
Comprehension baseline
Tested 60 recently consented patients across three sites on four critical facts; recall was between 34% and 41%.
Plain-language rewrite
Rewrote the four critical sections with clinical and ethics review, then tested at three reading levels.
Ethics committee review
Full review with two ethics committees before pilot, including the withdrawal-rate safety question.
Site-staff time study
Measured the consent conversation before and after; six additional minutes was acceptable to all pilot sites.
“The patients understand what randomisation means now. That was never true before and we all knew it.”
Principal Investigator, oncology network · under NDA
NEXT STUDY · 27 / 30 · DEFENCE & GOVTECH