Coming out soon
We have developed a machine learning and rule based tool called the Clinical Trial Risk Tool using natural language processing. The Clinical Trial Risk Tool allows a user to upload a trial protocol and which categorises the protocol as high, medium, or low risk of ending uninformatively.
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
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Clinical trials are fundamental for generating the data needed to develop new treatments, ultimately improving patient care and advancing healthcare systems worldwide (you can read more in our recent post about the Importance of Clinical Trials). However, despite their essential role, these trials are often financially burdensome, which can hinder research efforts and limit patient access to innovative therapies.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Clinical trials are the backbone of clinical drug development. They are essential for advancing medicine, testing new therapies, and ensuring patient safety before drugs reach the market. Yet, despite enormous investment, approximately 90% of all clinical trials fail to achieve regulatory approval, according to recent industry studies.[1] Failed trials result in significant financial losses — the average cost of a failed Phase III trial alone can exceed $100 million.
This post originally appeared on Fast Data Science’s blog on LinkedIn. Clinical trials are essential for medical advancement but are not without risk. Delays, budget overruns, and compliance issues can derail the most carefully planned studies. Proactive risk management is the key to ensuring patient safety, maintaining regulatory compliance, and achieving successful trial outcomes. In this article we’ll explore the key risks in clinical trials, how AI-powered tools like the Clinical Trial Risk Tool can help mitigate these risks, and practical strategies for ongoing risk monitoring.