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.
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| Vaccine trial? | |
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| Number of interventions |
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.
Introduction People have asked us often, how was the Clinical Trial Risk Tool trained? Does it just throw documents into ChatGPT? Or conversely, is it just an expert system, where we have painstakingly crafted keyword matching rules to look for important snippets of information in unstructured documents? Most of the tool is built using machine learning techniques. We either hand-annotated training data, or took training data from public sources. How We Trained the Models inside the Clinical Trial Risk Tool The different models inside the Clinical Trial Risk tool have been trained on real data, mostly taken from clinical trial repositories such as clinicaltrials.
Over the years, the overall cost of the drug development process has been exponentially increasing, prompting the adoption and use of adaptive clinical trial design software. Though there are practical difficulties and barriers in implementing clinical trial solutions, these problems are adequately addressed to overcome these issues as they arise. With advancements in software technologies, further improvements are being made to the software’s adaptive clinical trial design. Despite these progresses, just only a handful of well-established software with various types of clinical trial adaptations is currently available.
A clinical trial protocol is a document which serves as the step-by-step playbook for running the trial. The clinical trial protocol guides the study researchers to run the clinical trial effectively within a stipulated period. The prime focus of the clinical trial protocol is to ensure patients’ safety and data security. [1, 2] As the clinical trial protocol is an essential document for the seamless execution of the clinical trial, reviewing (peer-reviewing) the protocol is essential to ensure the scientific validity/viability/quality of the protocol.
