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)

Clinical Trial Data Lookup Google Sheets™ plugin

Clinical Trial Data Lookup Google Sheets™ plugin

Clinical Trial Data Lookup Google Sheets™ plugin Do you need to look up clinical trial data from the NCT ID? Fast Data Science has developed a Google Sheets™ add-on (plugin) which finds clinical trials data. The plugin uses the clinicaltrials.gov API. Clinical Trial Data Google Sheets™ Plugin Install plugin Install the free Google Sheets™ plugin for looking up clinical trial data Install Plugin The user will provide a number of NCT IDs in column A (or whichever one they choose) in the Google Sheet™, and the tool will look up those NCT IDs and retrieve information on those trials and populate that information into columns.

How to make a clinical trial site budget

How to make a clinical trial site budget

You may have been tasked with creating a clinical trial site budget. This is a budget itemising all the costs that will be incurred at the study site. The site budget may be needed To estimate the total cost of that site running part of the trial, as part of a bid to the CRO or sponsor To identify who needs to be reimbursed for each cost item To ascertain whether or not it is feasible to run the trial at that site To ensure that the site is reimbursed for the costs that they incur while running the trial If you are building a site budget, the most important document is the study protocol.

Clinical Trial Risk Tool approved for UK government use

Clinical Trial Risk Tool approved for UK government use

Fast Data Science are pleased to announce that the Clinical Trial Risk Tool, has been accepted as a supplier on the UK Government’s G-Cloud 15 framework. The G-Cloud 15 framework allows public sector bodies to buy cloud-based computing services such as AI, hosting, software and support directly without lengthy, costly traditional tender processes. What does the Clinical Trial Risk Tool do? The Clinical Trial Risk Tool helps users to analyse clinical trial protocols and documents.