TrialValue CDCI · Clinical Development Cost Index
What clinical trials cost, study by study
We took 27,739 industry-sponsored studies registered on ClinicalTrials.gov, Phases I to IV, and ran each one through the TrialValue AI+ budget model. See how cost moves with phase and over time, then benchmark your own study against it.
Median total budget by phase
Each bar is the middle study in its group. The line shows where the middle half of studies fall, so you can see how wide the spread is.
Is it getting more expensive?
Median cost per patient by the year a study started. Each study is priced in its start year, using US consumer price inflation.
In 2025 prices the lines are almost flat: most of the rise is inflation. Recent years include studies still running, whose end dates are planned.
Where cost per patient is highest
Median cost per patient for 16 therapeutic areas across Phases I to III.
Challenge these figures
A benchmark is only useful if people test it. Here is how ours compares with the best-known published estimate, and how to tell us where we are wrong.
Our Phase III median
$45.3M
$143K per patient, 5,977 studies, median 311 patients. Full trial cost: CRO, sites, vendors and pass-through costs, excluding the cost of making the study drug. In 2025 prices.
Moore et al., 2018
$19M
Median estimated cost of 138 pivotal trials behind FDA approvals in 2015–16, about $41,000 per patient. A different scope and costing method. JAMA Internal Medicine
Think we are wrong?
Send us an actual budget, a published figure or a flaw in the method. We log every challenge and say what changed.
Challenge a figureWhy our figures run higher
- Full cost. Each estimate covers the CRO, sites, third-party vendors and pass-through costs. Only the sponsor's own cost of making the study drug is left out.
- Costed where the sites are. The model uses each study's actual mix of sites and regions from ClinicalTrials.gov to set cost rates.
- Tested ratios. The ratios for CRO, vendor and pass-through costs come from more than 10 years of RHIEOS budget work, checked against published sources.
- Ranges, not single points. The model gives a likely range for every study. This page shows medians and the middle half of studies so that outliers do not drive the picture.
Ways to go further
Benchmark one study, license the full report, or build it into your contracts.
- Benchmark your study: your likely range, every cost line and the assumptions behind it
- Licence: a PDF report for your team with every breakdown, the area-by-phase grid, study-shape trends and method notes
- Index-linked contract clause licence: a ready-to-use clause that ties budget or rate changes in a contract to the index, with the right to cite it. Licensed per contract or per year
A budget benchmark for your own study is €1,950. The CDCI report licence is €2,500 a year for one user and €6,000 for a company; the clause licence is quoted. Read the licence terms.
How we built it
Where the studies come from
ClinicalTrials.gov, run by the U.S. National Library of Medicine. We include interventional Phase 1 to 4 studies with an industry lead sponsor that started between 2015 and 2025, and that are completed, active, recruiting or terminated.
How a study becomes model inputs
- Therapeutic area comes from each study's MeSH disease terms and their parent terms
- Phase 1 studies in healthy volunteers with no disease terms are grouped as healthy volunteers
- Region comes from the countries of the listed sites
- Patients is the enrolment figure; sites is the number of listed locations
- Months runs from start to primary completion
- Combined phases (I/II, II/III) are run as the higher phase
- Phase IV studies are run as approved medical products. Their visit count (8 per patient before the therapeutic-area adjustment) comes from 21 protocol schedules we counted, so it is less firmly based than Phases I to III
- The headline tiles cover Phases I to III. Phase IV is shown as its own group and trend line
- Every study is run as a new drug or biologic, with no prior sponsor relationship and on-site visits
- Studies that test a device alongside a drug or biologic (about 1%) are run as drug studies; device-only studies are left out
What the figures are, and are not
Each budget is a TrialValue AI+ estimate of the full cost of a study of that shape, not what the sponsor actually spent. Figures are in 2025 prices unless marked; the trend uses US CPI-U annual averages from the Bureau of Labor Statistics. We publish medians and middle halves, never single studies, and hide any group with fewer than 10 studies.
How the index is run, reviewed and corrected is set out in the CDCI charter.
What the model cannot see. Most registry records do not include the study's own visit schedule, so each study gets the typical visit count for its therapeutic area and phase. A study's own benchmark report uses its protocol, which can move the figure substantially.
Studies left out
Version
2026.11.3: Phase IV added (1,067 studies). 2026.11.2: first public release. All changes are listed on the changes page.
© 2026 RHIEOS Ventures Ltd. TrialValue® is a registered trademark. You may quote figures shown on this page with credit: “TrialValue CDCI, RHIEOS Ventures, 2026-11-08”. Any other reuse of the index or its data needs a licence. A licence covers the report only; study-level data and the model are not supplied. Source data: ClinicalTrials.gov.