Question 1 of 3
Pragmatic trials compare treatments during routine care. Participation remains voluntary and requires informed consent and appropriate safety oversight.
The Right to Trial
Give every patient the right to join a clinical trial for the most promising treatments—with a clinician, at a licensed treatment center, wherever they live. Every patient gets more options. Every result helps us find what works.
How Montana is accelerating clinical discovery
SB 535
Montana removed the terminal-illness restriction, licensed experimental treatment centers, and required outcome monitoring. Patients and providers now have a practical path to more treatment options.
How Montana is accelerating clinical discovery
Montana removed the terminal-illness restriction in 2023. In 2025, SB 535 created licensed experimental treatment centers, direct provider-patient payment agreements, outcome monitoring, adverse event reporting, and an access requirement funded by 2% of each center's net annual profits.
2015
Montana creates an initial access path for eligible patients.
2023
The state removes the terminal-illness restriction from its Right to Try law.
2025
The law defines experimental treatments and establishes state licensing, safety, consent, and oversight requirements.
2026
Final rules take effect and Montana publishes the experimental treatment center application.
Read the official enrolled SB 535 , final rules , and licensing page .
Earlier Right to Try laws created permission for a narrow group of patients, but not a delivery system or a public evidence system. Montana built the delivery path. Right to Trial adds pragmatic trials and published results.
Traditional Right to Try
Montana SB 422 + SB 535
Right to Trial proposal
See the treatments and trials most likely to help with your condition.
Review the possible benefits, risks, costs, alternatives, and your right to stop.
Get care from qualified professionals at a licensed treatment center.
Your result becomes part of a public comparison of treatment outcomes.
Average wait for a first treatment
221.7
years
40.5
years
181.2 years sooner
The world we can create
At today's pace, the average untreated disease waits 222 years for its first effective treatment. Give willing patients a place in low-cost clinical trials, and the central estimate falls to 41 years.
Montana is the enacted precedent. The original Right to Try spread from one state in 2014 to 41 states by 2018 — tap your state to see what Right to Trial would mean there, then add your voice.
Patients say yes when asked.
The system mostly never asks.
For the entire world.
people with chronic disease are willing to participate
Click any underlined number to inspect its source, assumptions, and uncertainty.
Current clinical trial costs are 82x times higher than pragmatic trial alternatives.
Traditional clinical trials cost $41K per participant, exceeding median annual income in many countries.
The average cost to develop a new drug is $2.6B, reflected in pharmaceutical pricing.
Regulatory delays contribute to an estimated 21,000-120,000 preventable deaths per decade.
Current trial eligibility criteria exclude 86.1% of patients with the condition being studied.
95% of known diseases lack FDA-approved treatments, with research concentrated on the remaining 5%.
The average time from discovery to widespread clinical adoption is 14 years.
An estimated 45.1B potential treatment combinations remain untested with current methodologies.
Approximately 2.4B people worldwide suffer from diseases with inadequate treatment options.
No major disease has been cured in over 44 years, highlighting the need for new research paradigms.
There are about rare diseases. Roughly still lack an effective treatment.
Right to Try creates access. Standardized outcomes turn isolated treatment decisions into comparable evidence about what works.
When approved treatments have failed, informed adults can still make a choice with their clinician.
The same simple before-and-after measures show whether treatment helped.
De-identified results show which treatments helped, which failed, and for whom.
Per patient in a real pragmatic trial.
Reference cost per participant.
Median cost per participant.
That tiny line on the left? That's ALL of modern medicine.
You cannot have "diminishing returns" when you haven't even started.
The 9.5M figure above only counts single drugs against diseases. Modern medicine increasingly uses combination therapies (standard in oncology, HIV, cardiology).
Note: We use the conservative 9.5M figure in our main calculations because single-drug trials are more straightforward. But the combination therapy space shows the true scale of unexplored medicine.
Clinical trials are how we discover which treatments work for which diseases. At current trial capacity, we find first effective treatments for only ~15 diseases per year.
Reference funding supports pragmatic trials per year and first treatments per year.
Critics argue: "Just funding more trials won't proportionally increase discoveries - we've picked the low-hanging fruit."
This is wrong for six reasons:
Diminishing returns apply to repeated attempts at the same problem. We're proposing to attempt problems we've never tried.
Pragmatic trials per year under reference funding.
First treatments found per year.
Time to cover the untreated-disease queue.
Treatments exist. Safe compounds exist. Patients are waiting.
The missing ingredient is trial capacity. That's a logistics problem, not a scientific frontier.
Patients find trials. Clinicians compare options. Researchers learn from every result. Here is how a decentralized FDA makes all three easier.
Search for trials based on your condition, location, and preferences.
Review comprehensive outcome data before deciding to join a trial.
Illustrative demo data — hypothetical future therapy
Complete informed consent and enroll in your chosen trial.
Schedule lab tests, provider visits, and import your health records.
Record your diet, treatment adherence, symptoms, and more.
View personalized analytics about your health and treatment response.
Receive personalized daily check-ins from your FDAi AI agent that monitors your progress, collects data, and provides insights in a conversational way.
Your personal health assistant
Good morning, Sarah! How are you feeling today after your treatment yesterday?
I'm feeling better today. The headache is gone but I still feel a bit tired.
That's good progress! Your fatigue has decreased by 40% since last week. Would you like to see how your symptoms compare to others in your trial?
Yes, please show me.
Our AI analyzes patient EHR data to identify and rank the most suitable and effective clinical trials, saving you time.
Review detailed outcome labels, compare trial arms (including standard of care), and assign patients directly.
Track key metrics, patient-reported outcomes, and overall trial status through an intuitive dashboard.
P12345: Mild ARIA reported
P67890: Headache (resolved)
The new and improved FDA.gov would make it effortless for researchers to create a trial and invite patients to join.
Upload protocols, pre/post-clinical data, and register your supply chain through the FDA.gov V2's intuitive interface.
Automatically receive and select liability insurance quotes per subject with transparent pricing.
Define patient pricing, required data collection, and refundable deposits to optimize your trial.
Track inventory, fulfill patient orders, and manage the entire treatment supply chain with end-to-end visibility.
Access real-time insights, analyze effectiveness data, and make informed decisions with comprehensive dashboards and reporting tools.
A person with no adequate approved treatment can make an informed choice with a clinician.
The same simple measures show how their treatment compares with every other option.
De-identified results reveal what helps, what fails, and which patients respond best.
Patients and caregivers
Show what another supervised treatment option would mean when approved treatments are not enough.
Get startedClinicians
Help make consent, treatment review, monitoring, records, and patient safety work in real care.
Get startedResearchers
Choose the small set of outcomes that lets one patient's result improve treatment rankings for everyone.
Get startedPublic educators
Share the patient story, answer local questions, and show what Montana already proved possible.
Get started