Keep track of clinical trial cost and risk

The Clinical Trial Risk Tool analyses the text of your clinical trial protocol with AI to find:
Design issues - is the trial likely to end without delivering informative results? This could be due to underpowering, inadequate statistical analysis
Recommendations - the tool will give you recommendations to improve your trial design
Predicted cost - how much is the trial likely to cost in dollars, based on models of past trials
Itemised per-patient budget and site budget (coming soon!) - a spreadsheet showing itemised costs of procedures calculated from the schedule of events
Compliance with SPIRIT, CONSORT, and FDA rules (coming soon!)

Coming out soon

Clinical Trial Risk Tool Version 2.0

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Clinical Trial Risk Tool

We have developed an AI tool called the Clinical Trial Risk Tool which allows a user to upload a trial protocol and which categorises the protocol as high, medium, or low risk of ending without delivering informative results.

When a pharmaceutical company develops a drug, it needs to pass through several phases of clinical trials before it can be approved by regulators.

Before the trial is run, the drug developer writes a document called a protocol. This contains key information about how long the trial will run for, what is the risk to participants, what kind of treatment is being investigated, etc.

The tool is open-source under MIT licence and it does not save any of your data.

Clinical Trial Risk Tool

The problem is that each protocol is up to 200 pages long and the structure can vary.

Currently, professionals at a funding organisation read the protocols and perform a subjective assessment of the trial’s cost, complexity, and risk of ending uninformatively.

One of the most common causes of a trial ending uninformatively is underpowering. There are several indicators of high risk of uninformativeness which can be identified in a protocol, such as a lack of and or an inadequate statistical analysis plan, use of non-standard endpoints, or the use of cluster randomisation. Low-risk trials are often run by well-known institutions with external funding and an international or intercontinental array of sites. These indicators can be referred to as features or parameters.

This project shows what is possible with natural language processing. The tool may be extended in future to identify a more complete set of cost, complexity, or uninformativeness risk factors.

Benefits or details include

The tool assists a human in assessing the cost, complexity or risk of uninformativeness of a trial, and understanding which factors contribute to the cost, complexity and risk of uninformativeness.
Reviewers are able to assess trials more rapidly.
The tool may augment certain processes in the approval and funding of clinical trials.
The tool could be used to inform stakeholders about the most impactful features for complexity, cost, and informativeness or risk of uninformativeness.
The tool can assist reviewers in assessing trials more consistently.
At present the tool is limited to 2 pathologies: HIV and TB, but it may be extended in future.
The current tool is designed primarily with trials in LMIC countries in mind but will work on trials globally.
Phases 1, 2, 3 and 4 covered.
The tool has been coded in Python and the source code is available on Github under MIT licence.

The risk factors the tool identifies

Pathology
Phase
Is a SAP (statistical analysis plan) present?
Has the effect estimate been disclosed?
Number of subjects?
Number of arms?
Countries of investigation
Trial uses simulation for sample size?
The features are then passed into a scoring formula which scores the protocol from 0 to 100, and then the protocol is flagged as HIGH, MEDIUM or LOW risk
The risk factors the tool identifies

How to cite the Clinical Trial Risk Tool?

If you would like to cite the tool alone, you can cite:

Wood TA and McNair D., Clinical Trial Risk Tool: software application using natural language processing to identify the risk of trial uninformativeness. Gates Open Res 2023, 7:56 doi: 10.12688/gatesopenres.14416.1.

A BibTeX entry for LaTeX users is

@article{Wood_2023,
  doi = {10.12688/gatesopenres.14416.1},
  url = {https://doi.org/10.12688%2Fgatesopenres.14416.1},
  year = 2023,
  month = {apr},
  publisher = {F1000 Research Ltd},
  volume = {7},
  pages = {56},
  author = {Thomas A Wood and Douglas McNair},
  title = {Clinical Trial Risk Tool: software application using natural language processing to identify the risk of trial uninformativeness},
  journal = {Gates Open Research}
}

Blog

Articles about the Clinical Trial Risk Tool

Building clinical trial budgets from the schedule of events: white paper

Building clinical trial budgets from the schedule of events: white paper

Outsourcing clinical trials: the pros and cons in 2026

Outsourcing clinical trials: the pros and cons in 2026

Guest post by Youssef Soliman, medical student at Assiut University and biostatistician In 2025, the outsourcing of clinical trials has become a common strategy for pharmaceutical and biotechnology sponsors. Facing rising R&D costs and complicated studies, sponsors turn to Contract Research Organizations (CROs) and other external partners to manage clinical trials. This practice, known as outsourcing clinical trials, is adopted as a best practice for containing costs and enhancing efficiency in drug development [1].

How the Clinical Trial Risk Tool helps you make an itemised trial budget

How the Clinical Trial Risk Tool helps you make an itemised trial budget

Creating clinical trial budgets from protocols Creating a clinical trial budget is a fiddly and time consuming process. The playbook for running the clinical trial is a document called the protocol. You can find examples of protocols here. The protocol states how many participants will take part in the trial and also what visits and procedures will take place. Above: a protocol. Source: NCT04128579 A clinical trial manager must read the protocol and look for all pieces of information in the protocol that is relevant to the budget, in particular the Schedule of Events (also called Schedule of Assessments or Schedule of Activities), which is a table or series of tables which indicate which procedures and assessments will take place on which the visits.

Try The Clinical Trial Risk Tool

Clinical Trial Risk Tool