The Clinical Trial Risk Tool has been featured in a guest column in Clinical Leader, titled A Tool To Tackle The Risk Of Uninformative Trials, in cooperation with Abby Proch, Executive Editor at Clinical Leader.
In the article, Thomas Wood of Fast Data Science highlights the problem of “uninformative” clinical trials – those that don’t provide meaningful results, even if the drug being tested is effective or ineffective. He distinguishes these from simply “failed” trials and emphasises the ethical and financial waste they represent. Wood explains that while “uninformativeness” lacks a formal definition, it can be understood by examining the five conditions of an “informative” trial as outlined by Zarin, Goodman, and Kimmelman (2019): addressing an important question, meaningful design, feasibility, scientific validity, and timely, accurate reporting. Trials excluded from meta-analyses due to bias are often considered uninformative.
Wood describes how the Clinical Trial Risk Tool tackles this problem by assessing trial protocols against these criteria. He suggests expanding the tool to include a template clinical trial budget derived from real-world cost data (e.g., Sunshine Act disclosures). Further enhancements could include identifying endpoints and inclusion/exclusion criteria, then searching clinical trial registries (like ClinicalTrials.gov) for similar past trials to help users evaluate their planned trial’s design choices.
Wood also suggests tailoring the tool for different user profiles (patient advocates, financial planners, medical professionals) by providing personalised feedback and recommended actions for protocol improvement. The goal is not to replace human review, but to help users identify design gaps and high-risk indicators early in the process.
Fast Data Science is a leading data science consultancy firm providing bespoke machine learning solutions for businesses of all sizes across the globe, with a concentration on the pharmaceutical and healthcare industries.
Guest post by Youssef Soliman, medical student at Assiut University and biostatistician Designing a high-quality clinical trial protocol is critical for the success of any study. A protocol is the blueprint that outlines every aspect of a trial. In an ideal world, a flawless protocol would require no revisions and include only essential elements. In reality, however, the average protocol undergoes 2–3 amendments and often contains excessive data collection and overly complex entry criteria.
Clinical trials have long been the foundation of medical breakthroughs, but traditional methods often stumble over slow timelines, high costs, and difficulties in finding the right participants. Artificial intelligence (AI) — a technology ready to transform this landscape by making trials faster, more affordable, and smarter. The accelerating adoption of AI in clinical trials signals a major shift in healthcare research. It is already making significant strides in transforming clinical trials.
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