Updates to the Clinical Trial Risk Tool

Updates to the Clinical Trial Risk Tool

We have improved the Clinical Trial Risk Tool in the last 6 months, making it more user friendly and taking on board the feedback that we’ve received. We’ve improved the accuracy of the machine learning components too.

The tool now outputs its key figures such as risk levels and estimated cost in easily readable cards, so you can see at a glance the key takeaways from your protocol:

easily readable cards

The risk factors are now organised into collapsible categories, so you can explore them easily without an information overload.

The risk factors are now organised into collapsible categories

The tool identifies endpoints and inclusion and exclusion criteria. In future, we are hoping to use this to retrieve trials with comparable endpoints or criteria from the registries such as ClinicalTrials.gov.

endpoints and inclusion and exclusion criteria

Check your trial design

Check your protocol

Upload your clinical trial protocol in PDF form to the Clinical Trial Risk Tool and check the design against our checklist. Soon we will also support CONSORT and SPIRIT criteria.

We have an easily digestible set of recommendations for the user to improve the trial, so you can see what are the high priority actions that you need to take with your protocol.

recommendations for the user to improve the trial

What’s coming up soon in the Clinical Trial Risk Tool

Currently we’re working on a feature to allow the user to generate an itemised budget for the trial in Excel from the schedule of events. We expect this to take a few months and to be finished in Q4 of 2025.

We are also working on making the tool output the probability of success for the trial. A number of groups have calculated aggregate statistics around trials proceeding from Phase 1->Phase 2, or Phase 3->approval, etc, e.g. MIT’s Project Alpha or Chufan Gao, Automatically Labeling Clinical Trial Outcomes, so these statistics or machine learning models could be integrated into the tool, and in addition to outputting the “risk score” it could also output the “probability of success” or similar, based on past trials.

We hope to also produce an accountable budget range (where should a reasonable bid fall), based on past trials.

References

  1. Gao, Chufan, et al. Automatically Labeling Clinical Trial Outcomes: A Large-Scale Benchmark for Drug Development. arXiv preprint arXiv:2406.10292 (2024).

  2. Shomesh Chaudhuri, Joonhyuk Cho, Andrew W. Lo, Manish Singh, and Chi Heem Wong, Debiasing Probability of Success Estimates for Clinical Trials (2022)

Building clinical trial budgets from the schedule of events: white paper

Building clinical trial budgets from the schedule of events: white paper

Outsourcing clinical trials: the pros and cons in 2026

Outsourcing clinical trials: the pros and cons in 2026

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].

How the Clinical Trial Risk Tool helps you make an itemised trial budget

How the Clinical Trial Risk Tool helps you make an itemised trial budget

Creating clinical trial budgets from protocols Creating a clinical trial budget is a fiddly and time consuming process. The playbook for running the clinical trial is a document called the protocol. You can find examples of protocols here. The protocol states how many participants will take part in the trial and also what visits and procedures will take place. Above: a protocol. Source: NCT04128579 A clinical trial manager must read the protocol and look for all pieces of information in the protocol that is relevant to the budget, in particular the Schedule of Events (also called Schedule of Assessments or Schedule of Activities), which is a table or series of tables which indicate which procedures and assessments will take place on which the visits.