I am pleased to announce the Clinical Trial Risk Tool, which is now open to the public to use.
The tool is available at https://clinicaltrialrisk.org/tool.
Screenshot of the tool
The tool consists of a web interface where a user can upload a protocol in PDF or Word format, and ultimately a number of features were extracted, such as number of subjects, statistical analysis plan, effect size, number of countries, etc.
The tool which can estimate the risk of HIV and TB trials ending uninformatively and will soon be extended to cover other metrics such as trial complexity and cost.
The NLP model was developed as an ensemble of components which extracted different aspects of information from the text, including rule-based (hand-coded) and neural network designs.
The model’s output features were then condensed down via a clinical trials risk model which ultimately produces a three-level risk traffic light score. The full analysis can be exported as XLSX or PDF.
Over the years, the overall cost of the drug development process has been exponentially increasing, prompting the adoption and use of adaptive clinical trial design software. Though there are practical difficulties and barriers in implementing clinical trial solutions, these problems are adequately addressed to overcome these issues as they arise. With advancements in software technologies, further improvements are being made to the software’s adaptive clinical trial design. Despite these progresses, just only a handful of well-established software with various types of clinical trial adaptations is currently available.
A clinical trial protocol is a document which serves as the step-by-step playbook for running the trial. The clinical trial protocol guides the study researchers to run the clinical trial effectively within a stipulated period. The prime focus of the clinical trial protocol is to ensure patients’ safety and data security. [1, 2] As the clinical trial protocol is an essential document for the seamless execution of the clinical trial, reviewing (peer-reviewing) the protocol is essential to ensure the scientific validity/viability/quality of the protocol.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction As we move toward 2025, clinical trial regulations are undergoing significant transformation. This shift is being fueled by technological advancements, changing healthcare needs, and an increasing emphasis on transparency and patient safety. In this post, we will explore the key clinical trial regulations shaping the clinical trial landscape, the challenges professionals face, and the strategies they must adopt to navigate this ever-evolving environment.
