Patient's Right to Trial Initiative

Treatments arrive 181 years sooner.

With all 50 states adopting licensed treatment centers, the analysis estimates 5.48× faster treatment discovery. Patients and payers fund care that also generates evidence on which treatments work.

Open the impact lab
Premature deaths prevented
9.19 billion

Lifetime total across future generations

Healthy years restored
483.28 billion DALYs

Years gained through longer, healthier lives

Implementation cost / DALY
$0.000134

State adoption and shared registry

Treatment access that generates evidence.

About 6,650 rare diseases still have no effective treatment. At the current rate, roughly 15 receive a first treatment each year. Exploring that queue takes ~443 years; the average target waits ~222. Many post-Phase-1 compounds, repurposed drugs, combinations, and doses are never tested because nobody can finance conventional Phase 2 and 3 trials.

The Patient's Right to Trial Initiative changes the financing constraint. Licensed centers provide eligible experimental treatments while patients or payers cover treatment-related care, trial-site services, and permitted study costs. Participants follow shared protocols; other eligible uses contribute separately labeled observational outcomes.

The analysis estimates that nationwide adoption brings first treatments forward by ~181 years. Earlier treatment prevents deaths and restores healthy years across future generations.

Explore the impact of faster treatment discovery.

Choose how many states adopt the framework, how much faster treatments are discovered, and how much disease they prevent. The results update as you change each input.

States adopting

Multiplier increment scales with 50/50.

50

Click a tile to adopt or drop a state. Montana is ringed — it already licensed experimental treatment centers.

5.48×

Assumed discovery rate relative to today. Paper estimate: 5.48× (range 1.1–15).

92.6%

Share of disease and aging deaths and lost healthy years that future treatments prevent. Paper estimate: 92.6%.

15

Status-quo pace of first effective treatments. Paper 15 (range 8–30).

100.0%

Your estimate of the chance this scenario succeeds. Used to calculate probability-weighted results.

Effective multiplier

5.48×

Years earlier

181 yr

Lives saved

9.19 billion

Healthy years (DALYs)

483.28 billion

Disability-eq. hours

1.65 quadrillion

Implementation cost

$65 million

Cost / DALY

$0.000134

Cost / life

$0.00707

Most diseases still wait centuries.

About 6,650 rare diseases have no effective treatment. At roughly 15 first treatments a year, clearing that queue takes ~443 years. The average wait is half that. Faster discovery brings those first treatments forward.

Average years to first treatment

Untreated diseases

6,650

95% of ~7,000 rare diseases

Current first treatments / yr

15

Status-quo discovery pace

Queue, status quo

443 yr

Diseases ÷ current rate

Queue, modeled

81 yr

Diseases ÷ accelerated rate

Average wait now

222 yr

Half the queue

Average wait modeled

40 yr

Half the new queue

Years pulled forward

181 yr

avgWait × (1 − 1/m)

New first treatments / yr

82.2

5.48× the current pace

The range of estimated outcomes.

The paper varies discovery speed, implementation cost, and preventable disease burden. These charts approximate its published distributions. The histogram shows the spread of results; the line shows the chance of reaching at least each value.

Histogram

Chance of reaching each outcome

Chance the result is at least this large

Dashed marks are the paper’s 5th / median / 95th. Solid white is your current lab scenario (9.19 billion).

Baseline
9.19 billion
Mean
9.4 billion
Median
8.82 billion
Std. dev.
4.13 billion
90% range
3.71 – 17.2 billion

What the legislation changes

Four evidence requirements for treatment centers.

Montana’s Senate Bill 535 established licensed experimental treatment centers for post-Phase-1 therapies, with a $10,000 application fee, $5,000 renewal, and 2% of net profits supporting access for qualifying residents. Its rules cover treatment access and outcome tracking. The proposed Right to Trial bill adds four evidence requirements.

  • Enroll

    Register a prospective protocol, obtain informed consent, report serious safety events, and place each patient in the applicable federal trial or treatment-access pathway.

  • Compare

    Prespecify outcomes and use randomization or another adequate control when feasible. Report observational findings separately from controlled treatment effects.

  • Pool

    Send standardized, de-identified baseline and outcome data from each licensed center to a shared registry.

  • Publish

    Continuously publish results for each treatment–condition pair, including negative and harmful results.

Conventional trial costs create a development bottleneck.

A candidate can finish Phase 1 and still be too costly to develop. Conventional Phase 3 runs about $41,000 per participant. Trials integrated into routine care can cost around $929 per participant — a 44× reduction. Complex, high-risk studies use specialized sites.

Cost per trial participant

Trial-cost reduction

44.1×

$41,000 vs $929 is the paper’s central pair (ranges $20k–$120k and $97–$3,000). Additional candidates — doses, combinations, subtypes — raise the chance the first effective treatment arrives sooner.

Implementation cost

$65 million

Cost / life

$0.00707

Implementation cost per healthy year in this scenario: $0.000134.

The calculation

How the estimate is calculated.

Start with the number of diseases awaiting treatment and the current discovery rate. Calculate how much sooner treatments arrive, then multiply those years by the annual deaths and disability they prevent.

  1. 01

    How long does the remaining treatment queue take at the current rate?

    6,650 untreated ÷ 15/yr

    Paper central 443 years (90% range 255–841).

    443 years

  2. 02

    How long does the average therapeutic target wait?

    443 ÷ 2

    If discoveries arrive uniformly, the average wait is half the clearance time. Paper 222 years.

    222 years

  3. 03

    How much earlier do treatments arrive?

    222 × (1 − 1/5.48)

    Partial state adoption scales the increment from 1× toward the full-adoption multiplier.

    181 years earlier

  4. 04

    How many healthy years does earlier treatment restore?

    2.88 billion DALYs/yr × 92.6% × 181 yr

    Same structure for deaths: 150,000 disease/aging deaths per day × 365 × years × avoidable share.

    483.28 billion DALYs

  5. 05

    What is the implementation cost per restored healthy year?

    $65 million ÷ 483.28 billion DALYs

    State-adoption work scales with the number of states; the $50 million registry estimate is shared.

    $0.000134

Effective multiplier in this scenario: 5.48×. Lives: 9.19 billion. Disability-equivalent hours: 1.65 quadrillion (healthy years restored × disability share × 8,760 hours/year).

State adoption and a shared registry: $65 million.

The estimate covers state-adoption and implementation work plus the first ten years of a shared registry. Patients or payers cover treatment-related care, trial-site services, and permitted study costs separately. The analysis assumes centers sustain the registry after its first decade, without a new state appropriation.

Included in the estimate

  • State adoption and implementation work (~$15 million at full adoption)
  • Shared registry, first ten years (~$50 million)
  • Common evidence standards

Paid separately

  • Treatment delivery, paid by patients or payers
  • Licensed treatment and pragmatic-trial sites
  • Manufacturing, distribution, and post-Phase-1 assets
  • Review, compliance, and payer contracts tied to evidence

Federal requirements

How state access fits federal rules.

Federal Right to Try serves eligible patients who cannot join a clinical trial of the drug. Interventional trials require an IND or another FDA-authorized pathway. Montana’s treatment-center rules cover access; they specify that centers do not administer clinical trials.

FDA approval requires substantial evidence from adequate and well-controlled investigations. Its guidance supports streamlined randomized trials integrated into routine care, including oncology trials through Project Pragmatica.

IND sponsor charges are generally limited to direct drug costs. Sites may recover pharmacy, nursing, equipment, and study-related procedure costs.

Medicare’s Coverage with Evidence Development is the closest payment analogue: cover specified services inside an approved study, then reconsider using the results. The Patient's Right to Trial Initiative applies that idea outside Medicare.

State adoption

Adapting Montana’s framework.

Montana already built the licensed-center and independent-review frame. Infinita stood up the first private Experimental Treatment Review Board and describes a coordinated pathway of review, licensed administration, monitoring, evidence generation, and early commercialization for post-Phase-1 therapies.

Other states can adapt the licensing and review framework, adding shared enrollment standards, controlled comparisons, pooled outcomes, documented fees, and safety monitoring.

Original Right to Try spread from one state in 2014 to 41 by 2018. The proposed evidence requirements give participating states a common way to compare and publish treatment results.

Montana’s treatment-access pathway.

Infinita established Montana’s first private Experimental Treatment Review Board and is coordinating clinics and post-Phase-1 submissions.

How treatment review and licensing work

Eligible post-Phase-1 treatments go to the Montana ETRB — a private board run by Montana Governance Services Inc. under the Infinita umbrella. Reported review fee: $12,500. Licensed experimental treatment centers then administer. Two applications (neuropathy and hearing loss) were already in as of late July 2026.

Infinita Fund

Infinita Fund supports companies working through startup-city and state-level regulatory pathways, including Montana SB 535.

Podcasts

Recent conversations with Infinita’s founder and U.S. lead on how SB 535 actually works — who pays, what the board reviews, and why federal Right to Try barely moved because biotechs could not charge.

Official links

Assumptions behind the estimates.

The time horizon, discovery rate, and health effects used in the calculation.

Sources and methodology.

Inputs and reported intervals come from Sinn’s Universal Right to Try with Evidence impact analysis. The calculator uses its formulas; the distribution charts use 4,000 illustrative draws fitted to its published summary statistics.

  1. 1NIH Common Fund. NIH pragmatic trials / HCS Research Collaboratory (2025).
  2. 2Sertkaya et al. Key cost drivers of pharmaceutical clinical trials in the United States. FDA study via NCBI.
  3. 3Sinn, M. P. Right to Trial & FDA Upgrade Act (2025). doi:10.5281/zenodo.19076852.
  4. 4Montana 69th Legislature. Senate Bill 535: experimental treatments (2025).
  5. 5Montana DPHHS. MAR notice 2026-427.2, experimental treatment center rules (2026).
  6. 6U.S. FDA. Right to Try eligibility.
  7. 7U.S. FDA. Demonstrating substantial evidence of effectiveness (2026).
  8. 8U.S. FDA. Integrating RCTs into routine clinical practice, draft guidance (2024).
  9. 9U.S. FDA. Project Pragmatica (2025).
  10. 10U.S. FDA. Charging for investigational drugs under an IND (2024).
  11. 11CMS. Medicare Coverage with Evidence Development (2024).
  12. 12Sinn, M. P. The Continuous Evidence Generation Protocol (2025). doi:10.5281/zenodo.18203375.
  13. 13Infinita. Bridging the gap from biotech to clinic — Montana SB 535 pathway (2026).
  14. 14Goldwater Institute. Alaska becomes 41st state to enact Right to Try (2018).
  15. 15Montana Experimental Treatment Review Board. Independent private review under SB 535 (2026).
  16. 16Infinita Fund. Information about companies using startup-city and state regulatory pathways.
  17. 17Regalado, A. Montana’s plan to become an experimental medical hub. MIT Technology Review (30 Jul 2026).
  18. 18Koka, A. & DiGiorgio, A. Right-to-Try 2.0: Inside the Montana Model with Niklas Anzinger. The Doctors’ Lounge (11 Aug 2026).
  19. 19Anzinger, N. & Martin, S. The Ultimate Guide to Montana SB 535. Infinita City Times Ep. 114 (14 Aug 2026).

Full parameter appendix: rtt-impact.acceleratedmedicine.org/knowledge/appendix/parameters-and-calculations