We have developed a machine learning and rule-based tool using natural language processing which allows a user to upload a trial protocol, and which categorises the protocol as high, medium or low risk of ending uninformatively. The tool is at https://clinical.fastdatascience.com and is open-sourced on Github. You can read an explanation of how the tool works here, and a description of how we validated its accuracy here.
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. One of the most common causes of a trial ending uninformatively is underpowering. 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 is an initial Proof of Concept (POC) which to showcase what is possible with natural language processing, with a view to moving towards a more comprehensive main project which may identify a more complete set of cost, complexity, or uninformativeness risk factors.
The tool is designed with a feedback form so that inaccurate data extractions can be reported back to the developers.
In addition the MIT License means that you are free to add features or extend the scope of the tool.
We hope that researchers who are considering submitting a protocol of a trial to a prospective source of funding will be able to use the tool as a kind of checklist to ensure that their trial is designed to reduce risk and increase the prospects of being funded.
This post originally appeared on Fast Data Science’s blog on LinkedIn. Clinical trials are vital for advancing medical innovation, yet they often face significant hurdles, including ensuring patient safety, adhering to regulatory requirements, controlling costs, and maintaining efficiency. Traditional risk assessment methods frequently need to be revised to address these complexities. Artificial Intelligence (AI) is transforming clinical trial management, offering data-driven solutions to predict and mitigate risks. AI-powered tools like the Clinical Trial Risk Tool have revolutionised trial planning and execution.
This post originally appeared on Fast Data Science’s blog on LinkedIn. Clinical trial protocols are often long, detailed documents—sometimes 200 pages—filled with vital information about sample size, treatment methods, and statistical plans. These protocols ensure the effective conduct of trials, but their complexity increases the time needed for manual reviews and the risk of human error. This is where Natural Language Processing (NLP) steps in. NLP enables machines to “read” unstructured data, such as clinical trial protocols, and extract key insights.
This post originally appeared on Fast Data Science’s blog on LinkedIn. Clinical trials, the backbone of medical science advancement, often grapple with high costs, complexity, and lengthy timelines. Fast Data Science presents Fast Clinical AI, a game-changing solution that harnesses the power of Natural Language Processing (NLP) and predictive modelling to tackle these challenges head-on. Streamlined Data Extraction and Analysis: Fast Clinical AI automates the extraction of critical information from trial protocols, significantly reducing manual efforts.
