Clinical Trial Risk Tool

We were contacted by a client in the pharmaceutical space who wanted a tool to assist reviewers in quantifying the risk of a clinical trial protocol. A protocol is a PDF document, typically up to 200 pages long, and contains a complete description of the plan of a trial: where it will take place, how many subjects will be recruited (the sample size), which interventions are to be tested, and how the statistical analysis is to be conducted.

Over a period of more than a year, we experimented with an ensemble of machine learning and rule-based models to extract features such as the pathology, phase, sample size, number of countries, number of arms, presence or absence of a statistical analysis plan, effect size, and whether simulation had been used to determine the sample size. These parameters were put into a simple linear risk model and the tool generates a PDF or Excel report which can be shared within the organisation. We deployed the tool to the internet at https://app.clinicaltrialrisk.org and open-sourced the code under MIT licence.

The tool has enabled the funding organisation to assess incoming trials for rapid triage. It has also helped professionals worldwide to make a rough risk assessment of their trials before submitting them for funding.