I am pleased to announce the Clinical Trial Risk Tool, which is now open to the public to use.
The tool is available at https://clinicaltrialrisk.org/tool.
Screenshot of the tool
The tool consists of a web interface where a user can upload a protocol in PDF or Word format, and ultimately a number of features were extracted, such as number of subjects, statistical analysis plan, effect size, number of countries, etc.
The tool which can estimate the risk of HIV and TB trials ending uninformatively and will soon be extended to cover other metrics such as trial complexity and cost.
The NLP model was developed as an ensemble of components which extracted different aspects of information from the text, including rule-based (hand-coded) and neural network designs.
The model’s output features were then condensed down via a clinical trials risk model which ultimately produces a three-level risk traffic light score. The full analysis can be exported as XLSX or PDF.
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].
