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
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan In 2025, clinical trials will continue to be a fundamental element in advancing medical science. Read more about: The Importance of Clinical Trials in Advancing Healthcare. However, as the landscape of medicine evolves, so do the ethical challenges that accompany these trials. The rapid progress of technology and the growing interconnectedness of the world present fresh ethical concerns that need to be tackled.
Guest post by Youssef Soliman, medical student at Assiut University and biostatistician Introduction Conducting a clinical trial risk assessment is now a regulatory expectation and a cornerstone of quality management in clinical research. A risk assessment is a systematic process for identifying and evaluating events that could affect the achievement of a trial’s objectives [1]. In practice, this means examining the protocol, procedures, and trial environment to spot hazards to patient safety, data integrity or compliance.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Clinical trials are essential for advancing medical science, yet they are inherently complex and involve a wide range of risks. As a result, effective risk management in clinical trials is crucial to ensuring their successful completion. Among the various approaches to managing these risks, clinical trials Key Risk Indicators (KRIs) have become essential tools. KRIs are precise, measurable metrics that serve as early alerts for potential risk exposures in clinical studies.