Coming out soon
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.
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.
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
You may have been tasked with creating a clinical trial site budget. This is a budget itemising all the costs that will be incurred at the study site. The site budget may be needed To estimate the total cost of that site running part of the trial, as part of a bid to the CRO or sponsor To identify who needs to be reimbursed for each cost item To ascertain whether or not it is feasible to run the trial at that site To ensure that the site is reimbursed for the costs that they incur while running the trial If you are building a site budget, the most important document is the study protocol.
Fast Data Science are pleased to announce that the Clinical Trial Risk Tool, has been accepted as a supplier on the UK Government’s G-Cloud 15 framework. The G-Cloud 15 framework allows public sector bodies to buy cloud-based computing services such as AI, hosting, software and support directly without lengthy, costly traditional tender processes. What does the Clinical Trial Risk Tool do? The Clinical Trial Risk Tool helps users to analyse clinical trial protocols and documents.
Estimating the total cost of a clinical trial before it runs is challenging. Public data on past trial costs can be hard to come by, as many companies guard this information carefully. Trials in high income countries and low and middle income countries have very different costs. Upload your clinical trial protocol and create a cost benchmark with AI Protocol to cost benchmark The Clinical Trial Risk Tool uses AI and Natural Language Processing (NLP) to estimate the cost of a trial using the information contained in the clinical trial protocol.