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://clinicaltrialrisk.org/tool 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.
A number of documents are needed to produce a complete and accurate clinical trial budget. The necessary documents typically include: the study protocol (generally the most important document for building a budget) the informed consent form the clinical trial agreement or sponsor contract any laboratory and pharmacy manuals the charge master or schedule of fees the sponsor’s budget. However, sometimes a sponsor will send only the synopsis to a CRO when requesting a quote.
Are you wondering how you can build a detailed clinical trial budget from the protocol, whether for a site, CRO, or sponsor? This may appear an intimidating task. You have to read the protocol carefully, find the schedule of events, calculate how many times each activity occurs during the trial, and slowly create an itemised budget spreadsheet. There are cost items buried in footnotes that you need to look for.
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].
