1

Building resilient clinical trials

Read first

1
2

The future of clinical trials

Reading now

2

What will define a remarkable trial in the next decade?

By David Tsai · Adapted from my keynote, February 2026

01Part 2

Overview

The question

What does the clinical trial of tomorrow look like?

These are ideas for where clinical trials could go. Some could sit inside one trial, some across many. I talked about them in a keynote in February of this year. I’ve spent the last decade and a half in clinical research and drug development, with the first five years spent at the clinical site. Enrolling patients for Phase I–IV studies.

More about me

This is the second part of that keynote. Read the first part: Building resilient clinical trials

02Single enrollment

You enroll once. But screen against all studies.

Today, you screen for one study. You qualify and enroll for just that one study. But what about the multiple other trials you may qualify for?

They sit right underneath it, from other sponsors in the same disease. You were never checked against them, so you never knew. You qualified for one and missed the rest.

Screening and enrollment are locked to one sponsor’s study. We shouldn’t settle for that.

For the same disease and the same kind of therapy, those studies typically use the same procedures.

Now take one indication with many sponsors, each testing a different drug. You consent once, and the same screening and enrollment procedures go to all of them.

Over time your results count against each study’s eligibility criteria. You can take part in one drug trial at a time, but you can be screened against all of them. No waste. No redundancy.

From the one study you join, your data and samples branch out to other studies and other sponsors. Today that is unheard of.

How close is it?What one consent and shared data enable

2.7MOne consent that covers later invitations.

people in the UK’s Our Future Health, whose consent includes being invited to other studies and trials.

Our Future Health, programme design and recruitment
500KOne collection of samples and scans that many teams reuse.

volunteers in UK Biobank, with more than 21,000 researchers in over 60 countries using the data.

UK Biobank, news release via EurekAlert, 14 July 2025
880KOne record that many teams read.

people in the NIH’s All of Us program, with more than 22,580 registered researchers working from their data.

NIH All of Us Research Program, update to the Council of Councils (J. Denny), May 2026

This is the future, a shared collective knowledge that benefits all patients.

Results count only inside each study’s window. In one published protocol, scans count for 28 days and labs for 72 hours, so only what has expired gets repeated.

Each treatment trial would still ask for your consent to its own risks; US rules require it (21 CFR 50.25). Screening windows and routine scans accepted for screening: protocol MK-6598-001, NCT05594043; every protocol sets its own.
03Adaptive protocol sharing

What one trial learns, the next one already knows

Here are three diseases. Each line is one study from a different sponsor, phase 1 to phase 3. The grey circles are time points inside each study.

Right now: Sponsor A runs a trial. Learns something critical about a biomarker. Publishes two years later. Sponsor B uses it.

Across more than 600 trials, the median time from finishing a study to releasing the data was almost 2 years, and a third were still unpublished after 4. This is too slow. We need to move faster.

Imagine instead: Sponsor A learns the biomarker predicts response. That learning goes into the shared knowledge base. Immediately.

Sponsor B, running a trial in the same therapeutic area, updates their eligibility criteria in real time. Sponsor C builds it into an upcoming trial. Collective learning.

In heart disease, one study learns something, and every heart study running or about to start can use it.

Then blood disorders. Inside each disease, every study now learns from the others.

Last, the diseases share with each other too, and every study becomes part of one shared collective learning trial.

Why should one trial suffer from a learning about a mechanism of action that another trial already has?

A shared collective knowledge that benefits all patients. Fewer people on a design someone else already learned from.

The gap from study end to paper uses the 23-month median in Ross et al., BMJ, 2012 (635 NIH-funded trials; 32% unpublished at a median 51 months). Changing eligibility in the middle of a study still means a protocol amendment and approval from an ethics board, and sharing from a study still running needs rules that protect its blinding. A piece of this already runs: TransCelerate member companies share de-identified historical control-arm data to improve trial design.
What already works this wayA regulated version of this exists inside a single study: platform trials that share one control arm, in the FDA’s master protocols guidance.

FDA master protocols guidance, 2022See these in the tracker

After Photo 51, Rosalind Franklin and Raymond Gosling’s 1952 X-ray of DNA

At first, it is all you.

Then it becomes strands of digital DNA.

04Your digital twin

Your living digital twin

You
Your twin

Not “a patient digital twin for drug discovery research” but your personalized, ever-evolving, patient digital twin.

Based on your data. Your genetics. Your lifestyle. Your current health history. And it foreshadows disease.

Your record copies over: every visit, lab and scan. It is a copy of you that you own, and you decide who sees which part.

On the twin those lines stop being separate. Each links to the others, and what they add up to can be inferred.

Then we can run trials on your twin without running them on your biological self.

In your body you can take part in one trial at a time. Through your twin you can test many drugs and see the outcomes.

And your digital twin, built from your continuous health data, runs 10,000 simulations. And gives you treatments built on your data.

And it says: “This treatment is built for you, from you, without ever having you participate in testing something out that may not work.”

0 simulations
Predicted benefitPredicted side effects

    Model prediction. For you and your doctor to weigh.

    What already works this wayIn 2022 the EMA qualified a method that uses digital twins to shrink a randomized control arm rather than replace it. No regulator has accepted a digital twin in place of a control arm in a pivotal trial.

    EMA qualification opinion on PROCOVA, 2022See these in the tracker

    Figure: MakeHuman base mesh, CC0.

    05Proactive (not Reactive)

    Proactive health care (not reactive trials)

    Right now, you get sick, then you look for a solution. If there is none, you go on a clinical trial. You enroll, you complete, you leave.

    85%

    of people 50 or older already have plaque in their heart’s arteries. It starts in 1 of 6 teenagers.

    Ultrasound of 262 donor hearts. Tuzcu, Circulation, 2001

    11.1 years

    How long you live

    Life expectancy lost, on average, after a first heart attack at 50, for a woman whose heart pumps weakly after it.

    SWEDEHEART, Circulation, 2024

    10.7 years

    How well you live

    Fewer years free of heart disease, diabetes and cancer from age 50, for women with no healthy habits against four or five.

    Li, BMJ, 2020

    The rise is caught before it becomes an illness.

    How long you live. And how well you live.

    Life is enough of a roller coaster. Our health doesn’t need to resemble one.

    When you get sick, or before you get sick, the system matches you to an intervention.

    Numbers are from the sources named.

    What already works this wayThis has a name: the learning health system, where knowledge is generated and applied inside care delivery. Pragmatic trials embedded in routine care already run on data from the electronic health record.

    Institute of Medicine, Best Care at Lower Cost, 2013 · Tuzzio & Larson, eGEMs, 2019See these in the tracker
    In closing

    The future of clinical trials

    It’s not about “better” clinical trials.

    It’s about what healthcare should be.

    Trials and care aren’t separate.

    They’re the same thing.

    Generating evidence while delivering care.

    Not after. Not separate. Integrated.

    Single enrollmentOne consent and one screening, checked against every study in your disease.
    Adaptive protocol sharingWhat one trial learns, the next one knows while it runs.
    Your digital twinMany drugs run through your twin, and you see the outcomes first.
    Proactive (not Reactive)The rise is caught before it becomes an illness.
    07What it means for us
    What it means for us

    When care and research are one, everyone gets better treatments, sooner.

    This was the future of clinical trials and where they should go. Part 1 shows the trials we run today and challenges we face and how we overcome them together.

    1

    Building resilient clinical trials

    Read Part 1

    1
    2

    The future of clinical trials

    You just read

    2