GITNUXREPORT 2026

Clinical Trial Statistics

Despite being numerous and global, most clinical trials are slow, costly, and fail to succeed.

Rajesh Patel

Team Lead & Senior Researcher with over 15 years of experience in market research and data analytics.

First published: Feb 13, 2026

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Statistic 1

Average cost of a Phase 3 trial is $20-50 million.

Statistic 2

Total R&D cost per approved drug: $2.6 billion (2023 adjusted).

Statistic 3

Phase 1 costs average $4-7 million per trial.

Statistic 4

Site payment per patient: $5,000-$10,000 in Phase 3 oncology.

Statistic 5

Patient recruitment costs: 20-30% of total trial budget.

Statistic 6

Decentralized trials reduce costs by 25-30%.

Statistic 7

CROs handle 70% of trials, charging $1-2 million per protocol.

Statistic 8

Data management costs: 15% of Phase 3 budget.

Statistic 9

Average trial duration: 6.5 years for Phase 2-3.

Statistic 10

Inflation-adjusted cost increase: 10% annually since 2010.

Statistic 11

Small biotech Phase 3: $100 million average.

Statistic 12

Global trial outsourcing saves 40% vs. in-house.

Statistic 13

Monitoring costs: $50,000 per site annually.

Statistic 14

Post-approval Phase 4: $10-20 million per study.

Statistic 15

AI in trials reduces data costs by 20%.

Statistic 16

Oncology trial costs: 2x higher than average ($50M Phase 3).

Statistic 17

Per-patient cost in US: $40,000 vs. $20,000 in India.

Statistic 18

Patient enrollment in clinical trials represents less than 5% of eligible cancer patients annually.

Statistic 19

Diversity in trials: Only 5% of participants in US trials are Black or African American.

Statistic 20

The median time to enroll the first patient in a Phase 3 trial is 4 months.

Statistic 21

85% of clinical trials fail to retain enough patients to meet enrollment goals.

Statistic 22

Women make up 42% of participants in cardiovascular trials despite higher disease burden.

Statistic 23

Pediatric trials enroll only 12% of children needed for rare disease studies annually.

Statistic 24

Site activation time averages 3-6 months, delaying enrollment by up to 30%.

Statistic 25

Use of electronic health records boosts enrollment rates by 25% in real-world studies.

Statistic 26

Attrition rate in Phase 3 trials averages 20-30% due to adverse events.

Statistic 27

Community-based recruitment increases minority participation by 15-20%.

Statistic 28

Global trial sites number over 300,000, but only 50% are activated efficiently.

Statistic 29

Patient registries improve enrollment speed by 40% for rare diseases.

Statistic 30

Social media recruitment reaches 3x more patients than traditional ads.

Statistic 31

Average trial enrollment per site is 10-15 patients for Phase 2 studies.

Statistic 32

COVID-19 accelerated virtual enrollment, increasing by 50% in 2021.

Statistic 33

70% of trials under-enroll due to geographic limitations.

Statistic 34

Incentives increase enrollment by 10-15% in healthy volunteer studies.

Statistic 35

Phase 1 trials enroll fastest, averaging 2 months to full cohort.

Statistic 36

Oncology trials have 25% higher dropout rates than other areas.

Statistic 37

As of 2023, ClinicalTrials.gov lists over 450,000 clinical trials registered worldwide.

Statistic 38

In 2022, the number of new interventional trials registered on ClinicalTrials.gov was approximately 35,000.

Statistic 39

About 60% of all clinical trials registered on ClinicalTrials.gov are Phase 3 or 4 studies.

Statistic 40

The United States sponsors nearly 40% of all global clinical trials.

Statistic 41

Europe accounts for 25% of the world's clinical trial activity as of 2023.

Statistic 42

Asia-Pacific region saw a 15% increase in clinical trial starts from 2021 to 2023.

Statistic 43

Over 80% of clinical trials fail to meet their primary endpoints.

Statistic 44

Decentralized clinical trials grew by 40% between 2020 and 2023 due to COVID-19.

Statistic 45

In 2023, oncology trials represented 25% of all new registrations on ClinicalTrials.gov.

Statistic 46

The average clinical trial now takes 8-10 years from Phase 1 to approval.

Statistic 47

40% of Phase 1 trials, 30% of Phase 2, 20% of Phase 3, and 10% of Phase 4 are oncology-focused.

Statistic 48

Phase 2 trials have the highest attrition rate at 70% failure to proceed.

Statistic 49

Globally, 25% of trials are Phase 1, 35% Phase 2, 30% Phase 3, 10% Phase 4.

Statistic 50

Adaptive Phase 2/3 designs increased from 5% to 20% of trials since 2015.

Statistic 51

Phase 3 trials take 3-5 years on average to complete.

Statistic 52

Only 10% of Phase 1 drugs reach Phase 4 market approval.

Statistic 53

Basket trials, combining phases, rose 300% from 2015-2023.

Statistic 54

Phase 1 oncology trials enroll 20-50 patients on average.

Statistic 55

Long-term follow-up in Phase 4 averages 5-10 years post-approval.

Statistic 56

Seamless Phase 2/3 trials reduce timeline by 2 years.

Statistic 57

Rare disease trials are 80% Phase 1/2 due to small populations.

Statistic 58

Dose-escalation in Phase 1 uses 3+3 design in 60% of cases.

Statistic 59

Phase 3 superiority trials comprise 70% of confirmatory studies.

Statistic 60

Umbrella trials span multiple phases for precision medicine.

Statistic 61

Phase 4 post-marketing trials monitor 1-5% of approved drugs annually.

Statistic 62

First-in-human Phase 1 trials increased 20% in cell/gene therapies.

Statistic 63

Oncology holds 35% of Phase 3 trials globally.

Statistic 64

Neurology Phase 2 success rate is 15%, lowest among areas.

Statistic 65

Cardiovascular trials: 50% Phase 3 non-inferiority designs.

Statistic 66

Overall clinical trial success rate from Phase 1 to approval is 9.6%.

Statistic 67

Oncology Phase 2 to 3 transition success: 35%.

Statistic 68

Biologics have 15% higher success rate than small molecules (12% vs. 10%).

Statistic 69

Rare disease drugs: 25% success rate due to accelerated approval.

Statistic 70

Alzheimer's trials: <1% success rate historically.

Statistic 71

COVID-19 vaccines: 90% Phase 3 success in Operation Warp Speed.

Statistic 72

Immuno-oncology drugs: 20% approval rate vs. 5% traditional chemo.

Statistic 73

Cardiovascular drugs: 10.4% Phase 1 to approval.

Statistic 74

Orphan drugs: 21% success vs. 11% non-orphan.

Statistic 75

Gene therapy trials: 35% success in Phase 3 to date.

Statistic 76

Antibiotic development: <2% success due to trial design issues.

Statistic 77

Cell therapy success: 16% overall Phase 1-approval.

Statistic 78

Precision medicine trials: 25% higher success in oncology.

Statistic 79

Neurology non-Alzheimer's: 8% success rate.

Statistic 80

Oncology trials account for 40% of all new starts.

Statistic 81

Neurology trials represent 12% of global registrations.

Statistic 82

Infectious diseases trials surged 300% during COVID-19 peak.

Statistic 83

Rare diseases have over 7,000 conditions but only 500 active trials.

Statistic 84

Cardiovascular trials comprise 10% of Phase 3 studies.

Statistic 85

Immunology/autoimmune trials grew 25% from 2018-2023.

Statistic 86

Diabetes/endocrine trials: 8% of total, with 60% Phase 3.

Statistic 87

Psychiatry/mental health trials: only 5% despite 20% disease burden.

Statistic 88

Vaccines trials: 15% increase post-COVID, mostly Phase 3.

Statistic 89

Gastroenterology trials focus 70% on IBD and liver diseases.

Statistic 90

Hematology trials: 90% oncology-related.

Statistic 91

Dermatology trials: 4% of total, rising with biologics.

Statistic 92

Ophthalmology trials doubled in gene therapy focus since 2017.

Statistic 93

Pulmonology: 7% of trials, COPD/asthma dominant.

1/93

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In a world where over 450,000 clinical trials are racing to deliver new treatments, the stark reality is that more than 80% will fail, exposing a critical need to transform how we develop the medicines of tomorrow.

Key Takeaways

As of 2023, ClinicalTrials.gov lists over 450,000 clinical trials registered worldwide.
In 2022, the number of new interventional trials registered on ClinicalTrials.gov was approximately 35,000.
About 60% of all clinical trials registered on ClinicalTrials.gov are Phase 3 or 4 studies.
Patient enrollment in clinical trials represents less than 5% of eligible cancer patients annually.
Diversity in trials: Only 5% of participants in US trials are Black or African American.
The median time to enroll the first patient in a Phase 3 trial is 4 months.
40% of Phase 1 trials, 30% of Phase 2, 20% of Phase 3, and 10% of Phase 4 are oncology-focused.
Phase 2 trials have the highest attrition rate at 70% failure to proceed.
Globally, 25% of trials are Phase 1, 35% Phase 2, 30% Phase 3, 10% Phase 4.
Oncology trials account for 40% of all new starts.
Neurology trials represent 12% of global registrations.
Infectious diseases trials surged 300% during COVID-19 peak.
Overall clinical trial success rate from Phase 1 to approval is 9.6%.
Oncology Phase 2 to 3 transition success: 35%.
Biologics have 15% higher success rate than small molecules (12% vs. 10%).

Despite being numerous and global, most clinical trials are slow, costly, and fail to succeed.

Costs

Average cost of a Phase 3 trial is $20-50 million.
Total R&D cost per approved drug: $2.6 billion (2023 adjusted).
Phase 1 costs average $4-7 million per trial.
Site payment per patient: $5,000-$10,000 in Phase 3 oncology.
Patient recruitment costs: 20-30% of total trial budget.
Decentralized trials reduce costs by 25-30%.
CROs handle 70% of trials, charging $1-2 million per protocol.
Data management costs: 15% of Phase 3 budget.
Average trial duration: 6.5 years for Phase 2-3.
Inflation-adjusted cost increase: 10% annually since 2010.
Small biotech Phase 3: $100 million average.
Global trial outsourcing saves 40% vs. in-house.
Monitoring costs: $50,000 per site annually.
Post-approval Phase 4: $10-20 million per study.
AI in trials reduces data costs by 20%.
Oncology trial costs: 2x higher than average ($50M Phase 3).
Per-patient cost in US: $40,000 vs. $20,000 in India.

Costs Interpretation

Behind every billion-dollar pill is a decade-long, multimillion-dollar waltz where the music's tempo is set by recruiting patients, paying sites, and outsourcing everything, all while desperately hoping that AI, decentralized models, or cheaper countries can slightly soften the annual financial gut-punch.

Enrollment

Patient enrollment in clinical trials represents less than 5% of eligible cancer patients annually.
Diversity in trials: Only 5% of participants in US trials are Black or African American.
The median time to enroll the first patient in a Phase 3 trial is 4 months.
85% of clinical trials fail to retain enough patients to meet enrollment goals.
Women make up 42% of participants in cardiovascular trials despite higher disease burden.
Pediatric trials enroll only 12% of children needed for rare disease studies annually.
Site activation time averages 3-6 months, delaying enrollment by up to 30%.
Use of electronic health records boosts enrollment rates by 25% in real-world studies.
Attrition rate in Phase 3 trials averages 20-30% due to adverse events.
Community-based recruitment increases minority participation by 15-20%.
Global trial sites number over 300,000, but only 50% are activated efficiently.
Patient registries improve enrollment speed by 40% for rare diseases.
Social media recruitment reaches 3x more patients than traditional ads.
Average trial enrollment per site is 10-15 patients for Phase 2 studies.
COVID-19 accelerated virtual enrollment, increasing by 50% in 2021.
70% of trials under-enroll due to geographic limitations.
Incentives increase enrollment by 10-15% in healthy volunteer studies.
Phase 1 trials enroll fastest, averaging 2 months to full cohort.
Oncology trials have 25% higher dropout rates than other areas.

Enrollment Interpretation

The clinical trial landscape is a heartbreaking paradox of immense global infrastructure and sluggish, inequitable execution, where technological leaps exist alongside a stubborn inability to reach or keep the very patients who need them most.

Global Statistics

As of 2023, ClinicalTrials.gov lists over 450,000 clinical trials registered worldwide.
In 2022, the number of new interventional trials registered on ClinicalTrials.gov was approximately 35,000.
About 60% of all clinical trials registered on ClinicalTrials.gov are Phase 3 or 4 studies.
The United States sponsors nearly 40% of all global clinical trials.
Europe accounts for 25% of the world's clinical trial activity as of 2023.
Asia-Pacific region saw a 15% increase in clinical trial starts from 2021 to 2023.
Over 80% of clinical trials fail to meet their primary endpoints.
Decentralized clinical trials grew by 40% between 2020 and 2023 due to COVID-19.
In 2023, oncology trials represented 25% of all new registrations on ClinicalTrials.gov.
The average clinical trial now takes 8-10 years from Phase 1 to approval.

Global Statistics Interpretation

The sheer volume of new clinical trials being launched, particularly in oncology, paints a picture of relentless ambition, yet it's sobering to know this high-stakes global effort remains a marathon where most hopefuls stumble before the finish line.

Phase Distribution

40% of Phase 1 trials, 30% of Phase 2, 20% of Phase 3, and 10% of Phase 4 are oncology-focused.
Phase 2 trials have the highest attrition rate at 70% failure to proceed.
Globally, 25% of trials are Phase 1, 35% Phase 2, 30% Phase 3, 10% Phase 4.
Adaptive Phase 2/3 designs increased from 5% to 20% of trials since 2015.
Phase 3 trials take 3-5 years on average to complete.
Only 10% of Phase 1 drugs reach Phase 4 market approval.
Basket trials, combining phases, rose 300% from 2015-2023.
Phase 1 oncology trials enroll 20-50 patients on average.
Long-term follow-up in Phase 4 averages 5-10 years post-approval.
Seamless Phase 2/3 trials reduce timeline by 2 years.
Rare disease trials are 80% Phase 1/2 due to small populations.
Dose-escalation in Phase 1 uses 3+3 design in 60% of cases.
Phase 3 superiority trials comprise 70% of confirmatory studies.
Umbrella trials span multiple phases for precision medicine.
Phase 4 post-marketing trials monitor 1-5% of approved drugs annually.
First-in-human Phase 1 trials increased 20% in cell/gene therapies.
Oncology holds 35% of Phase 3 trials globally.
Neurology Phase 2 success rate is 15%, lowest among areas.
Cardiovascular trials: 50% Phase 3 non-inferiority designs.

Phase Distribution Interpretation

This landscape reveals the brutal, high-stakes funnel of drug development: a heroic 40% of early research charges into oncology's front lines, only to face a 70% slaughter in Phase 2, but clever adaptations like seamless and basket trials are our increasingly sharp scalpel, cutting years from the process while still leaving a sobering 90% of hopeful compounds on the lab floor.

Success Rates

Overall clinical trial success rate from Phase 1 to approval is 9.6%.
Oncology Phase 2 to 3 transition success: 35%.
Biologics have 15% higher success rate than small molecules (12% vs. 10%).
Rare disease drugs: 25% success rate due to accelerated approval.
Alzheimer's trials: <1% success rate historically.
COVID-19 vaccines: 90% Phase 3 success in Operation Warp Speed.
Immuno-oncology drugs: 20% approval rate vs. 5% traditional chemo.
Cardiovascular drugs: 10.4% Phase 1 to approval.
Orphan drugs: 21% success vs. 11% non-orphan.
Gene therapy trials: 35% success in Phase 3 to date.
Antibiotic development: <2% success due to trial design issues.
Cell therapy success: 16% overall Phase 1-approval.
Precision medicine trials: 25% higher success in oncology.
Neurology non-Alzheimer's: 8% success rate.

Success Rates Interpretation

The pharmaceutical industry is a brutal casino where your odds of survival range from winning the lottery with a rare disease drug to a death sentence in Alzheimer's trials, proving that a well-targeted shot in the dark is still infinitely better than firing blindly.

Therapeutic Areas

Oncology trials account for 40% of all new starts.
Neurology trials represent 12% of global registrations.
Infectious diseases trials surged 300% during COVID-19 peak.
Rare diseases have over 7,000 conditions but only 500 active trials.
Cardiovascular trials comprise 10% of Phase 3 studies.
Immunology/autoimmune trials grew 25% from 2018-2023.
Diabetes/endocrine trials: 8% of total, with 60% Phase 3.
Psychiatry/mental health trials: only 5% despite 20% disease burden.
Vaccines trials: 15% increase post-COVID, mostly Phase 3.
Gastroenterology trials focus 70% on IBD and liver diseases.
Hematology trials: 90% oncology-related.
Dermatology trials: 4% of total, rising with biologics.
Ophthalmology trials doubled in gene therapy focus since 2017.
Pulmonology: 7% of trials, COPD/asthma dominant.

Therapeutic Areas Interpretation

While oncology enthusiastically hogs the trial spotlight like a starlet with forty percent of all new starts, psychiatry languishes backstage despite shouldering twenty percent of the disease burden, and rare diseases—a crowd of over seven thousand—mostly just wait for a turn that may never come.

Sources & References

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