FDA and CluePoints Extend Collaboration to Enhance Clinical Trial Data Integrity with AI and Machine Learning

The Food and Drug Administration (FDA) and CluePoints, a provider of statistical and AI-driven software solutions, have entered a new three-year Cooperative Research and Development Agreement (CRADA). This agreement aims to integrate artificial intelligence (AI) and machine learning (ML) to improve data quality assessment in multicenter clinical trials.

The collaboration between the FDA and CluePoints focuses on maintaining the integrity of clinical trial data and ensuring participant safety. Clinical research misconduct, such as data fabrication or omission, poses significant risks and can compromise public health. Traditionally, the FDA has relied on site inspections and whistleblowers to detect misconduct, but only a small percentage of clinical trial sites can be inspected due to the high volume of product filings.

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Under the original CRADA, CluePoints developed and enhanced software that ranks clinical trial sites based on anomalies, helping FDA inspectors prioritize which sites to inspect. This collaboration led to the deployment of CluePoints software in the FDA's high-performance computing environment, development of new statistical tests for detecting anomalous sites, improvements in site ranking algorithms, and enhancements to the user interface for FDA reviewers.

The new CRADA will focus on two primary objectives:

Enhancement of CluePoints SMART Software:

• The software will be developed to address a broader range of regulatory concerns, with a focus on decentralized trials (DCT) and electronic clinical outcome assessment (eCOA) and electronic patient-reported outcomes (ePRO) technologies.
• Improvements will be made in the detection of duplicate patients.
• AI/ML algorithms will be explored for their potential to support anomaly detection further.
• Research will continue on moderators of treatment effects, with the goal of developing deployable solutions within the FDA environment.

Support for FDA Processes:

• Enhancements to the SMART software and CluePoints monitoring platform will aim to better support FDA processes related to anomaly detection, review, and follow-up.
• The software will be adapted to improve site selection for FDA inspections.

The anticipated outcomes of the CRADA include improved detection of anomalous sites, better understanding of the interaction between various factors and data quality, and streamlined processes for data review and site selection for inspections. This collaboration is part of the FDA's efforts to leverage advanced technologies to ensure the integrity of clinical trial data and safeguard public health.