Care-Integrated Clinical Trials: The Patient Journey
THE CARE-INTEGRATED CLINICAL TRIALS INITIATIVE
Every patient's treatment can help the next patient
Radically accelerating medical discovery by letting any patient join trials of the most promising treatments.
MEET MARGARET
Margaret, 68
Margaret has Alzheimer's disease. Researchers have identified 573 existing drugs that might help her. Few have ever been tested for Alzheimer's.
Today
No evidence
No approved drug has helped her, and no trial is open near her. Her doctor has no evidence for any of the 573, and if she takes one, nobody records what happens.
With care-integrated trials
Treatment through her own doctor
Her doctor can recommend a screened treatment at a local clinic, and her result helps the next patient.
Frontiers in Pharmacology, 2023, ten-year review of drug repurposing for Alzheimer's.
Millions of patients are waiting
- Americans with Alzheimer's
- 7.4M
- Americans with Alzheimer's
- Americans with a rare disease
- 30M
- Americans with a rare disease
- Americans diagnosed with cancer each year
- 2.1M
- Americans diagnosed with cancer each year
- of rare diseases have no FDA-approved treatment
- 95%
- of rare diseases have no FDA-approved treatment
Sources: Alzheimer's Association, 2026 Facts and Figures; NIH; American Cancer Society, Cancer Statistics 2026.
Why promising treatments go untested
No one pays to test old drugs
573
drugs proposed for Alzheimer's are mostly untested, because no company can profit from testing a drug it can't patent.
No one learns from patients
99.8%
of Alzheimer's patients are in no study, so nothing is learned from their treatment.
Right to Try gives makers no incentive
$0
profit allowed under Right to Try: makers may charge only their costs, so few offer their drugs.
Sources: Frontiers in Pharmacology, 2023; USC Schaeffer Center; Alzheimer's Association, 2026 Facts and Figures; Right to Try Act, 2018.
PROOF PRAGMATIC TRIALS WORK
A trial built into everyday care saved a million lives
How RECOVERY worked: any NHS hospital could enroll patients during their normal care, with little extra paperwork, and outcomes came from routine health records.
89 days
to show that a cheap steroid cuts deaths among the sickest COVID patients by up to a third. Typical trials take years.
4
treatments found that save lives, out of more than a dozen tested side by side.
$500
per patient, 82 times less than the $41,000 of a typical trial.
Sources: RECOVERY Collaborative Group, New England Journal of Medicine, 2021; NHS England, 2021; Manhattan Institute, 2023; Moore et al., JAMA Internal Medicine, 2018.
CARE-INTEGRATED CLINICAL TRIALS
Do the same for every disease, in everyday care
Any patient can get the most promising treatments through their own doctor, after independent review and with written consent.
Clinics can charge for treatment, so they have a reason to offer treatments nobody else will fund.
Every result is published, good or bad, so the next patient chooses better.
HOW IT WORKS
Six steps that help the next patient
- Explore options: Compare treatment rankings and outcome labels
- Talk with your doctor: Get a recommendation and decide on a treatment plan
- Consent and cost: Decide in writing, knowing the price
- Treatment and tracking: Share good and bad outcomes
- Results reported: De-identified, in a public registry
- Rankings and labels improve: The next patient chooses better
Explore options
Compare treatment rankings and outcome labels
Talk with your doctor
Get a recommendation and decide on a treatment plan
Consent and cost
Decide in writing, knowing the price
Then it starts again, with better data
Rankings and labels improve
The next patient chooses better
Results reported
De-identified, in a public registry
Treatment and tracking
Share good and bad outcomes
STEP 1 · EXPLORE OPTIONS
Margaret starts by comparing her options
- 1
Donanemab
- Effectiveness estimate
- 57/ 100
- Safety estimate
- 48/ 100
- Annual cost estimate
- $38,000 USD
- Time to effect
- 6-12 months
View Outcome Label - 2
Lecanemab
- Effectiveness estimate
- 55/ 100
- Safety estimate
- 50/ 100
- Annual cost estimate
- $36,500 USD
- Time to effect
- 6-12 months
View Outcome Label - 3
Donepezil
- Effectiveness estimate
- 45/ 100
- Safety estimate
- 60/ 100
- Annual cost estimate
- $525 USD
- Time to effect
- 4-6 weeks
View Outcome Label
Rankings and outcome labels
Compare benefits, side effects and costs.
Public directory
Every participating clinic, with location and status.
OUTCOME LABELS
A label that gets better with every patient
Lecanemab for early Alzheimer's disease
Lecanemab Placebo
Decline over 18 months
Points lost. Shorter is better.
Dementia severity (CDR-SB)
27% less
1.21 points1.66 pointsThinking and memory (ADAS-Cog14)
26% less
4.14 points5.58 pointsDaily activities (ADCS-MCI-ADL)
37% less
3.5 points5.5 points
Side effects
Share of patients.
Infusion reactions
26%7%Brain swelling (ARIA-E)
13%2%Signs of brain bleeding (ARIA-H)
17%9%Headache
11%8%
Where the evidence comes from
Clinical trials: including the ones that failed
Every treated patient: their real-world outcome
Side-effect reports: from clinics and doctors
Source: Leqembi (lecanemab) FDA prescribing information, 2023, Study 2.
INDEPENDENT TREATMENT REVIEW
An independent board approves every treatment first
Who reviews
- Five or more members, including a physician, a researcher and an ethicist
- A non-scientist and an outside member
- No financial ties to the clinic or maker
- Flat fees, never paid per approval
What they check
- The evidence
- The treatment plan
- Each provider's competence
- Conflicts of interest
- The consent form
What qualifies
- Early safety testing in people
- Or a documented record of safe use in people
- Or a well-understood biological method with lab or animal data
- Or device-specific evidence
STEP 2 · TALK WITH YOUR DOCTOR
Her own doctor recommends it, even by video
Her neurologist
MargaretRequired
- Her doctor's recommendation
- Her written consent, which she can sign online
Not required
- A life-threatening illness
- Being unable to join a trial
- Using up approved drugs first
STEP 3 · CONSENT AND COST
She decides in writing, knowing the price
Consent form · Experimental treatment
- 1The exact treatment
- 2Her doctor's view of realistic outcomes
- 3Other options, including none
- 4Known and unknown risks
- 5Who pays, and what she may owe
- 6What data is collected, and how it's protected
If she can't consent, a legal representative can.
STEP 4 · TREATMENT AND TRACKING
Care close to home, with outcomes measured
What her clinic records
- 1Her treatment and dose
- 2Her starting condition
- 3Better, same, worse, stopped or died, on a set schedule
- 4Side effects
- 5A coded ID, not her name
Optional · Easier tracking
- Phone check-ins
- Wearables
- AI calls or texts
No required app or vendor. Normal medical records count.
SAFETY NET
If something goes wrong, the system reacts
- 1
Serious side effect
Reported to the board within five days.
- 2
Board reassesses
Also if a trial elsewhere stops for safety.
- 3
New patients paused
Until a serious safety problem is resolved.
- 4
Current patients protected
They can continue if stopping is riskier.
Every protocol is also reviewed at least once a year.
STEP 5 · RESULTS GO PUBLIC
Every result is published
Example annual board report · 48 patients
- Improved
- 21 · 44%
- No real change
- 14 · 29%
- Worsened
- 6 · 13%
- Stopped
- 4 · 8%
- Died
- 0 · 0%
- Lost to follow-up
- 3 · 6%
- Serious side effects
- 2 · 4%
Nothing hidden
Bad and unclear results must be published too.
Privacy first
Small groups are combined so no one can be identified.
STEP 6 · RANKINGS AND LABELS IMPROVE
How one result becomes shared evidence
Her clinic
Data stays with her doctor
Outcome report
Coded and de-identified
Board report
Yearly public results
Evidence system
Combines all clinics
Rankings and outcome labels
Compare benefits and harms
Her result improves the next patient's decision
Every clinic reports in one open format, so any evidence system can combine the results.
MARGARET'S FIRST YEAR
One patient's path, start to finish
Week 0
Explores
Compares labels; video visit with her doctor.
Week 1
Consents
Signs the form; a charity helps pay.
Week 2
First dose
At a clinic near home.
Months 1-6
Tracked
Memory tests and phone check-ins.
Month 6
Recorded
Coded outcome filed, good or bad.
Year 1
Label updated
Her result joins the evidence.
Margaret got treatment through her own doctor, and the next patient learns from her.
THE CARE-INTEGRATED CLINICAL TRIALS ACT
What the act does
Review: An independent board approves each treatment, clinic and consent form.
Access: A treating doctor's documented recommendation and written consent are all a patient needs.
Payment: Clinics may charge for treatment. No insurer or state program has to pay.
Safety: Serious side effects are reported within five days, and an unresolved safety finding stops new patients.
Results: Every outcome is reported in one open format and published, de-identified.
Every patient's experience becomes evidence for the next.
- Any patient can get the most promising treatments through their own doctor.
- Clinics can charge for treatment, so they offer treatments nobody else will fund.
- Every result is published, producing treatment rankings and outcome labels.
Learn more at acceleratedmedicine.org
MODEL ESTIMATE
We have tested 0.34% of what we already have
9,500compounds with a human safety record×1,000diseases=9.5 million
Tested: about 32,500 pairs (0.34%)Never tested: about 9.47 millionOver 2,000 years at today's pace
Most pairs will not work
If only 1 in 1,000 works, that is about 9,500 treatments nobody is looking for.
What care-integrated trials change
Doctors can already use approved drugs off-label, but nobody tracks the results. Care-integrated trials add drugs still in testing and track every outcome.
Source: How to End War and Disease, "The Untapped Therapeutic Frontier" (FDA, GRAS, ICD-10 and ClinicalTrials.gov data).
MODEL ESTIMATE
When will every untreated disease have a first treatment?
6,650 diseases have no treatment today. At today's pace, the last of them gets its first treatment in about 443 years. If every state adopted the act, in about 81.
- At today's pace15 diseases a year
- 443 years
- If every state adopts the actabout 82 diseases a year
- 81 years
181 years
sooner, on average
for a disease's first treatment
44×
lower cost per patient
$41,000 to under $1,000
8 years
less waiting after safety tests
available after board review
Assumes every state adopts the act and first treatments arrive 5.5 times faster. Source: Patient's Right to Trial Act impact paper, papers.acceleratedmedicine.org.
MODEL ESTIMATE
A year of healthy life for under $10
Cost per year of healthy life
$9.50
Care-integrated trials
at global scale, in everyday care
$184
Malaria bed nets
one of the best charities known
$100,000+
A typical new drug
at the usual U.S. price limit
- Care-integrated trials
- $9.50: too small to see at this scale
- Malaria bed nets
- $184: about 2 pixels wide
- A typical new drug
- $100,000+
About 19 times cheaper than bed nets. Over 10,000 times cheaper than a typical new drug.
Pragmatic trials at global scale (about 23 million patients a year), not the 50-state model on slide B2. A year of healthy life = one year without early death or disability, discounted 3% a year. Sources: Ubiquitous Pragmatic Trial Impact Analysis, papers.acceleratedmedicine.org; ICER.
Slide 1 of 22: Every patient's treatment can help the next patient