CluePoints Extends Collaboration with FDA to Enhance Clinical Trial Data Integrity


KING OF PRUSSIA, PA — CluePoints has announced an extension of its collaboration with the Food and Drug Administration (FDA), aiming to enhance the integrity of clinical trial data and ensure participant safety.

The FDA and its stakeholders prioritize the accuracy of clinical trial data to protect public health. Misconduct, such as fabrication or data omission, endangers participants and undermines the reliability of study results. The FDA uses site inspections and whistleblowers to identify potential misconduct. However, given the volume of product filings, the agency can inspect only a small percentage of trial sites.

To address this, CluePoints’ software helps the FDA prioritize site inspections by creating a ranked list of anomalous sites. The original Cooperative Research and Development Agreement (CRADA) between the FDA and CluePoints led to several advancements. These include deploying CluePoints software in the FDA’s high-performance computing environment and enhancing statistical tests and site ranking algorithms.

The new proposed CRADA focuses on two primary objectives. Firstly, it aims to develop and enhance CluePoints SMART™ software to tackle a broader range of regulatory concerns. This includes leveraging date/time data, which is increasingly important with decentralized trials and the use of electronic clinical outcome assessment (eCOA) and electronic patient reported outcomes (ePRO) technologies. The project will also improve detection of duplicate patients and explore how Artificial Intelligence (AI) and Machine Learning (ML) can support anomaly detection. Further research will examine treatment effect moderators and develop a deployable software solution for the FDA.

Secondly, the CRADA aims to enhance how SMART™ software and the CluePoints monitoring platform support FDA processes related to anomaly detection, review, follow-up, and site selection for inspections.

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This collaboration is expected to yield significant benefits for the FDA. These include improved detection of anomalous sites, a better understanding of how various factors interact with data quality, and streamlined processes for data review and site selection.

CluePoints’ continued partnership with the FDA represents a crucial step forward in safeguarding the integrity of clinical trial data and advancing public health objectives.

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