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 cost calculator. This is a regression model, trained on real clinical trial data.
| Trial is for condition | |
| Phase | |
| Vaccine trial? | |
| Country | |
| Sample size | |
| Number of interventions |
The clinical trial risk tool will let you upload a PDF protocol and will directly identify some risk and cost features.
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 the tool to cover other disease indications including COVID, Cystic fibrosis, Enteric and diarrheal diseases clinical trials cost models, Influenza clinical trials cost modelling, Malaria clinical trials cost models, Motor neurone disease, Multiple sclerosis, Neglected tropical diseases clinical trials cost modelling, Oncology, and Polio clinical trials cost modelling.
In addition to cost estimation, we’re looking at RCT risk assessment, informativeness and RCT 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.
The Clinical Trial Risk Tool unifies the technical knowledge in the protocol (medical or statistical information) with the business knowledge (finances, risk management).
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 helps you 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.
Clinical trial designs vary considerably, impacting study execution, patient recruitment, endpoints, and treatment delivery. Here’s a brief summary of some common designs: First-In-Human (FIH) Studies These are the initial human trials for a new drug, procedure, or treatment, focusing primarily on safety. Cohort Studies These observational studies follow a group of individuals over an extended period to assess risk factors associated with developing specific conditions. Case-Control Studies These studies compare individuals with a particular disease or condition (cases) to similar individuals without the disease (controls) to identify potential risk factors.
This post originally appeared on Fast Data Science’s blog on LinkedIn. The Growing Role of AI in Clinical Trials Clinical trials are vital for advancing medicine, but managing them efficiently is a constant challenge. Traditional methods for assessing risks and estimating costs often miss the mark, leading to delays and unexpected expenses. This is where Artificial Intelligence (AI) and Natural Language Processing (NLP) come into play, offering smarter, data-driven solutions to streamline trial planning and management.
This post originally appeared on Fast Data Science’s blog on LinkedIn. Budgeting is one of the most critical steps when planning a clinical trial. Clinical trials are complex, multi-phase studies that require significant resources, and understanding the costs associated with each phase is crucial for an accurate clinical trial budget. In this post, we’ll explore the different phases of clinical trials and the key factors that influence their costs, providing insights into how to prepare a comprehensive budget that aligns with your trial’s needs.
