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The 0.06% Problem - Who Actually Gets to Try New Treatments

Keywords

war-on-disease, 1-percent-treaty, medical-research, public-health, peace-dividend, decentralized-trials, dfda, dih, victory-bonds, health-economics, cost-benefit-analysis, clinical-trials, drug-development, regulatory-reform, military-spending, peace-economics, decentralized-governance, wishocracy, blockchain-governance, impact-investing

Humanity spends $60B (95% CI: $50B-$75B) a year on clinical trials55. Here are the actual enrollment numbers:

Enrollment Data from ClinicalTrials.gov

US Trials (Cumulative)

  • Phase 1: 722,619 people (median: 33 per trial)
  • Phase 2: 2,181,530 people (median: 60 per trial)
  • Phase 3: 6,548,474 people (median: 237 per trial)
  • Phase 4: 2,718,541 people (median: 90 per trial)
  • Total: 12.2 million people across all active/recruiting/completed US trials

But that’s cumulative - trials running over many years. To get annual enrollment, divide by average trial duration (~2.7 years):

That’s the old estimate based on average trial duration. But we can do better.

A visualization of US clinical trial enrollment showing the distribution of 12.2 million participants across trial phases 1 through 4, including median participants per trial.

A visualization of US clinical trial enrollment showing the distribution of 12.2 million participants across trial phases 1 through 4, including median participants per trial.

The Better Method: Count Completed Trials

We analyzed trials that actually completed each year (not estimates):

US Interventional Trials (Phase 1-4 drug trials only):

  • 2024: 1.66M participants (3,038 completed trials)
  • 2023: 1.56M participants (3,557 completed trials)
  • 2022: 1.52M participants (3,631 completed trials)
  • 2021: 842K participants (3,601 trials)
  • 2020: 951K participants (3,366 trials)

Average US: ~1.5 million/year (interventional drug trials)

The US represents 54% of the global trials market138, so:

Global: ~2.8 million participants/year (strict definition - interventional only)

But this excludes observational studies, device trials, and behavioral interventions. If you count everything:

Global: ~5-8 million participants/year (all clinical research)

England’s data confirms the scale: 1.05 million participants in 2023/24139 across all study types.

A visualization showing the growth of US clinical trial participants from 2020 to 2024 and the comparative scale of global research markets.

A visualization showing the growth of US clinical trial participants from 2020 to 2024 and the comparative scale of global research markets.

Industry Standard: IQVIA 2022

The most authoritative source is IQVIA’s 2022 report29, showing:

Global: 1.9 million participants annually (2022)

This represents post-COVID normalization from the 4 million peak in 2021 (when COVID trials dominated). IQVIA tracks actual pharmaceutical industry data, making it more reliable than our ClinicalTrials.gov extrapolations.

Comparison of global clinical trial participant estimates for 2022, contrasting IQVIA’s industry-focused data with broader ClinicalTrials.gov extrapolations.

Comparison of global clinical trial participant estimates for 2022, contrasting IQVIA’s industry-focused data with broader ClinicalTrials.gov extrapolations.

Why the discrepancy with our 2.8M estimate?

  • IQVIA counts actual industry trials (interventional drug studies)
  • Our ClinicalTrials.gov analysis includes government/academic trials
  • Different completion date definitions
  • Our US-to-global scaling may overestimate

For our economic model, we use IQVIA’s 1.9M as the conservative baseline for current global trial capacity.

The Tragedy in Numbers

A funnel infographic illustrating the massive attrition from 2.4 billion chronic disease patients to the 1.08 billion willing to participate and the mere 1.9 to 5 million who actually enroll in clinical trials annually.

A funnel infographic illustrating the massive attrition from 2.4 billion chronic disease patients to the 1.08 billion willing to participate and the mere 1.9 to 5 million who actually enroll in clinical trials annually.

Chronic disease patients globally: 2.40B people (95% CI: 2.00B people-2.80B people)

Willing to participate in trials: 1.08B people (95% CI: 843M people-1.34B people) (44.8% (95% CI: 40%-50%))

Clinical trial participants annually: 1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) (interventional drug trials, IQVIA 2022)

Or ~5 million if counting all clinical research (observational, device, behavioral)

Among those who could benefit and are willing to help:

Using the conservative IQVIA figure (1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) ÷ 1.08B people (95% CI: 843M people-1.34B people) = 0.18%), your odds of actually getting into a drug trial are 1 in 566.

Even if you count all clinical research (5M ÷ 1.08B people (95% CI: 843M people-1.34B people) = 0.46%), your odds are only 1 in 215.

Meanwhile, 150k deaths/day people die every day from diseases we’re studying.

An enrollment funnel illustrating the massive gap between the 2.4 billion people with chronic diseases, the 1.08 billion willing to participate, and the 1.9 million actually admitted to drug trials.

An enrollment funnel illustrating the massive gap between the 2.4 billion people with chronic diseases, the 1.08 billion willing to participate, and the 1.9 million actually admitted to drug trials.

The Access Lottery

2.40B people (95% CI: 2.00B people-2.80B people) people are living with chronic diseases140 right now. That’s cardiovascular disease, cancer, diabetes, COPD, mental illness, chronic pain.

A scale comparison showing the massive population of 2.4 billion people living with chronic diseases versus the tiny sliver of 1.9 million people who gain access to drug trials.

A scale comparison showing the massive population of 2.4 billion people living with chronic diseases versus the tiny sliver of 1.9 million people who gain access to drug trials.

They’re alive. They’re suffering. And they could potentially benefit from the treatments we’re studying.

The ratio: 1 person gets access to drug trials for every 1,263 living with disease (using IQVIA’s 1.9M).

Even counting all clinical research (5M), it’s still only 1 in 480.

The Willingness Gap

And here’s what makes it even more infuriating: surveys show 49-51% of people are willing to participate in clinical trials78.

A comparison showing the massive disparity between the 50 percent of people willing to participate in clinical trials and the 0.08 percent who actually gain access, illustrating the ‘Willingness Gap’.

A comparison showing the massive disparity between the 50 percent of people willing to participate in clinical trials and the 0.08 percent who actually gain access, illustrating the ‘Willingness Gap’.

Half of humanity would say yes if asked.

But only 0.0792% (95% CI: 0.0761%-0.0819%) of disease patients actually get to participate in drug trials (1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) ÷ 2.40B people (95% CI: 2.00B people-2.80B people)).

Even counting all clinical research, it’s just 0.2% (5M ÷ 2.40B people (95% CI: 2.00B people-2.80B people)).

That’s not a recruitment problem. That’s an exclusion problem.

The system isn’t failing because people don’t want to help find cures. It’s failing because:

  • Trials only exist at major academic medical centers
  • Most people live too far away
  • Eligibility criteria exclude 90% of patients
  • Enrollment caps fill up instantly

We have 1.08B people (95% CI: 843M people-1.34B people) with chronic disease who are willing and able to participate. We’re enrolling 1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) in drug trials (or ~5M counting all clinical research).

We’re turning away 99.82% of willing participants (using drug trials), or 99.5% if counting all clinical research.

The Cost Per Patient

Using IQVIA’s 1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) drug trial participants:

$60B (95% CI: $50B-$75B) ÷ 1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) = $43,684 per participant annually

Even if we count all clinical research (5M participants):

$60B (95% CI: $50B-$75B) ÷ 5 million participants = $16,600 per participant annually

That’s not per treatment. That’s the overhead cost per human enrolled, covering:

  • Regulatory paperwork
  • Compliance monitoring
  • Data collection
  • Insurance against lawsuits
  • Committees reviewing committees
  • The salaries of people whose job is writing protocols

Phase 3 trials (median 237 participants24) cost $20M each. That’s $84,388 per patient. Not for the drug. For the trial.

A comparison of clinical trial overhead costs per participant relative to the price of a new car, illustrating the high administrative expense per human enrolled.

A comparison of clinical trial overhead costs per participant relative to the price of a new car, illustrating the high administrative expense per human enrolled.

You could buy each participant a new Honda Civic and still have money left over.

Why This Matters

If you get cancer, your odds of getting into a clinical trial are about 5%. If you’re unlucky enough to get a rare disease, your odds of a trial existing are basically zero.

A scale comparison showing the massive gap between the 2.4 billion people suffering from chronic disease and the tiny fraction of 1.9 million patients who participate in drug trials annually.

A scale comparison showing the massive gap between the 2.4 billion people suffering from chronic disease and the tiny fraction of 1.9 million patients who participate in drug trials annually.

The system isn’t designed to help sick people try treatments. It’s designed to generate data clean enough to satisfy regulators. The fact that some people get treatment is a side effect.

Humans spend $60B (95% CI: $50B-$75B) a year to help 0.0792% (95% CI: 0.0761%-0.0819%) of the 2.40B people (95% CI: 2.00B people-2.80B people) people suffering from chronic disease (using IQVIA’s 1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) drug trial participants).

Even counting all clinical research, it’s just 0.2% (5M participants).

The other 99.92% of disease patients (or 99.82% of willing participants) get to wait. And suffer. And while they wait, 150k deaths/day die every day.

Enrollment Data by Phase

Data from ClinicalTrials.gov:

Phase Trials Total Enrollment Median/Trial Cost/Patient
Phase 1 11,833 722,619 33 $15,909
Phase 2 14,852 2,181,530 60 $9,174
Phase 3 8,989 6,548,474 237 $5,650
Phase 4 5,790 2,718,541 90 $6,437

(Cost per patient calculated from phase spending estimates divided by participant counts)

What a 1% Treaty Could Do

The math is straightforward:

Today’s Capacity

A scale comparison visualizing the disparity between global military spending at 2.72 trillion and clinical trials spending at 60 billion, highlighting the magnitude of global resource allocation.

A scale comparison visualizing the disparity between global military spending at 2.72 trillion and clinical trials spending at 60 billion, highlighting the magnitude of global resource allocation.

With 1% of Military Spending Redirected

A breakdown of the redistribution process showing how 1 percent of military spending flows into three distinct buckets: VICTORY bonds, IAB incentives, and the remaining majority for clinical trials.

A breakdown of the redistribution process showing how 1 percent of military spending flows into three distinct buckets: VICTORY bonds, IAB incentives, and the remaining majority for clinical trials.

With Your Decentralized Framework for Drug Assessment

A visual comparison of a decentralized drug assessment framework versus traditional trial models, highlighting remote enrollment, smartphone reporting, and continuous operation workflows.

A visual comparison of a decentralized drug assessment framework versus traditional trial models, highlighting remote enrollment, smartphone reporting, and continuous operation workflows.
  • Enrollment isn’t limited by proximity to trial sites
  • Patients report outcomes via smartphone
  • Trials run continuously instead of in isolated batches
  • Cost per participant drops to $929 (95% CI: $97-$3K) (pragmatic trial cost, based on RECOVERY trial benchmarks)

The Result

And we’d only be using a fraction of available capacity (23.4M patients/year (95% CI: 9.44M patients/year-96.8M patients/year) ÷ 1.08B people (95% CI: 843M people-1.34B people)).

Comparison of current clinical trial efficiency versus the proposed 1 percent Treaty model, highlighting the inverse relationship between cost-per-patient and total capacity.

Comparison of current clinical trial efficiency versus the proposed 1 percent Treaty model, highlighting the inverse relationship between cost-per-patient and total capacity.

The data would be better too. More diverse. More representative. Collected from people living their actual lives instead of visiting clinics every week.

The Bottom Line

1.90M patients/year (95% CI: 1.50M patients/year-2.30M patients/year) people a year (drug trials, IQVIA 2022), at a cost of $43,684 each.

Or ~5 million if you count all clinical research (observational, device, behavioral) at $16,600 each.

A scale comparison infographic showing the narrow funnel of clinical research participation, contrasting the 2.4 billion people with chronic diseases against the 5 million in clinical research and 1.9 million in drug trials.

A scale comparison infographic showing the narrow funnel of clinical research participation, contrasting the 2.4 billion people with chronic diseases against the 5 million in clinical research and 1.9 million in drug trials.

2.40B people (95% CI: 2.00B people-2.80B people) people are living with chronic disease.

The ratio: 1 in 1,263 (drug trials) or 1 in 480 (all clinical research) among disease patients.

Among willing participants: 1 in 566 (drug trials) or 1 in 215 (all research).

A visual comparison showing the stark contrast between the total number of diseased patients and the tiny fraction who successfully enroll in drug trials, illustrating the 1 in 1,263 ratio.

A visual comparison showing the stark contrast between the total number of diseased patients and the tiny fraction who successfully enroll in drug trials, illustrating the 1 in 1,263 ratio.

The 99.92% of disease patients (99.82% of willing participants) who don’t get access to drug trials? They suffer. And 150k deaths/day die every day.


Methodology: Primary source: IQVIA 2022 report29 showing 1.9M global participants (post-COVID normalization). Supporting data from ClinicalTrials.gov API v2. Annual estimates based on phase-specific trial durations from ASPE.