Are your clinical trials risky? Are costs running away?
It’s very tricky to estimate clinical trial costs before a trial is run.
Try our free clinical trial cost calculator. This is a regression model for clinical trial cost breakdowns, trained on real clinical trial data.
| Trial is for condition | |
| Phase | |
| Vaccine trial? | |
| Country | |
| Sample size | |
| Number of interventions |
The Clinical Trial Risk Tool’s budget add-on allows you to generate a budget in multi-tabbed Excel format. The AI locates the Schedule of Events in the protocol PDF and looks up the costs of the activities. It then generates an Excel where each cohort or site is represented as its own tab, and the activities and visits on which they occur are translated into cost items to be summed. This is a bottom-up approach to trial costing.
Above: Video showing how the tool creates itemised per-subject budgets by reading the schedule of events from the protocol and combining with charge masters.
You can read more here about how the Clinical Trial Risk Tool helps you make an itemised trial budget. You can also download an example trial budget in Excel format generated by the Clinical Trial Risk Tool. This budget is generated from your protocol and charge master.
Find out about trial costs
In addition to the activity-based costing described above (based on the Schedule of Events), the Clinical Trial Risk Tool also supports a top-down cost estimation, also directly from your protocol text.
A large amount of the data needed to estimate the total cost of a clinical trial is contained within the unstructured text of the protocol. Notably, some items, such as CRO costs, will need to be inferred (examples include the number of CRA meetings, and the expected number of adverse events and serious adverse events).
The Clinical Trial Risk Tool, developed by Fast Data Science, will let you upload a PDF protocol and will directly identify some risk and cost features. We have a top-down approach to cost modelling where we have trained a model on past trials and predict the cost of a planned trial based on key features such as sample size, but we are currently developing a bottom-up approach which would allow the generation of an itemised budget in spreadsheet form.
Unlike other clinical trial cost calculators you may find online, our clinical trial cost models are regression models trained on past trials. You can download the training dataset here - the original source is here.
Here’s a preview of our training data that we used to develop our regression models:
| Indication | Technology | NCT# | Tech II | Enrollment | Trial Phase | Total Cost | Per Patient Cost ($PP) | Source for this Data | Name of the Source | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Advanced Myeloid Malignancy | biologic drug | - | 30 | Phase 1 | $328,000.00 | $10,933 | doc | SEC agreements | |||
| Blood Cancer | biologic drug | NCT03483324 | 9 | Phase 1 | $5,000,000.00 | $555,556 | doc | CIRM | |||
| Blood Cancer | biologic drug | NCT03925935 | 24 | Phase 1 | $6,192,579.00 | $258,024 | doc | CIRM | |||
| B cell cancers, Leukemia | biologic drug | NCT03088878 | 156 | Phase 1/2 | $18,292,674.00 | $117,261 | doc | CIRM | |||
| Blood Cancer | biologic drug | NCT02222688 | 26 | Phase 1 | $4,179,598.00 | $160,754 | doc | CIRM | |||
| Colon Cancer | biologic drug | NCT02953782 | 112 | Phase 1/2 | $10,234,048.00 | $91,375 | doc | CIRM | |||
| Leukemia, Acute Myeloid (AML) | biologic drug | NCT03248479 | 96 | Phase 1 | $5,000,000.00 | $52,083 | doc | CIRM | |||
| Blood Cancer, Solid Tumors | biologic drug | NCT02216409 | 88 | Phase 1 | $6,505,568.00 | $73,927 | doc | CIRM | |||
| Breast Cancer | biologic drug | NCT00781612 | 720 | Phase 3 | - | $104,186.49 | https://doc | KEI FOIA Response/University of Colorad | |||
| Stage IV Melanoma | cell therapy | NCT00438984 | 11 | Phase 1 | $936,164.00 | $85,106 | doc | FOIA’d NIH grants | |||
The Clinical Trial Risk Tool:
We originally developed the Clinical Trial Risk Tool to estimate costs of Tuberculosis and HIV trials. In 2024, we extended the scope of our clinical trial cost software to cover other disease indications including:
In addition to cost estimation, the Clinical Trial Risk Tool also provides clinical trial risk assessment (how to quantify the risk of a trial ending without delivering informative results), and clinical trial complexity.
When you’re planning a clinical trial, you have to write the protocol.
This is a PDF document which is 200 pages long.
It says what drug you are testing, who will participate in your trial, over what time period, and what they will be required to do. It may also say how you will manufacture the drug, how it will be delivered, where the trial will take place, and how you will analyse the data.
If you want an organisation to fund your trial (a sponsor), they will need to read the protocol and estimate the cost, and be satisfied that the trial is not too risky.
To complete this risk assessment and cost assessment, you will need experts in multiple fields to read and assess the protocol. This is subjective (different people might come to different conclusions) and it’s slow.
Find out about trial costs
The Clinical Trial Risk Tool unifies the technical knowledge in the protocol (medical or statistical information) with the business knowledge (finances, risk management) for clinical trial cost analysis.
Imagine you could have a tool which could read your protocols and estimate the cost and risk, immediately!
If you work for the trial sponsor, this works along with other clinical trial budget software to triage the protocols that you receive from investigators, identifying who’s worth pursuing.
In a pharmaceutical company, this helps your business plan cash flow and quantify and diversify risk.
If you are investing in pharmaceutical development, this helps you understand your exposure to risk.
If you’re a CRO (contract research organisation, i.e. the company that is contracted to run the trials), you can prepare quotes and cost estimates for your clients (pharma companies) quickly and easily.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Multi-Arm & Multi-Stage (MAMS) Clinical Trials Design Tips The design of clinical trials is increasingly challenged by the Rising Costs, limited availability of eligible patient populations, and the growing demand for timely therapeutic evaluation. Traditional parallel-group designs, which typically compare a single intervention to a control, are often insufficient to meet these pressures in terms of speed, efficiency, and resource utilization.
You can use the t-test when you want to compare the means (averages) of continuous data between two groups, such as blood pressure or maximum concentration of a drug in urine (Cmax). If you have data with a dichotomous outcome, you can use the Chi-Squared test instead - please try our Chi-Squared sample size calculator. The calculator below will calculate the minimum sample size for you. Your expected effect size d is the standardised effect size according to Cohen’s definition.
You can use the Chi-Squared test to analyse your trial data or A/B test data if you have two groups with a dichotomous outcome. For example, you have two arms in your trial: the placebo and the intervention arm, and your endpoint is either yes or no, such as “did the subject experience an adverse event during the trial”. The calculator below will calculate the minimum sample size for you. Your expected effect size w is the standardised effect size according to Cohen’s definition.
