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.
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].
