FDA and CluePoints Sign New 3 Year Cooperative Research and Development Agreement to Assess Data Quality using Statistical Modelling and Machine Learning



FDA extends its use of CluePoints to include AI/ML within an automated system to assess data quality in multicenter clinical trials

KING OF PRUSSIA, Pa., June 5, 2024 /PRNewswire/ — CluePoints, providers of leading statistical and AI-driven software solutions, and Food and Drug Administration (FDA) today announced an extension to their long-standing collaboration. FDA and its stakeholders have a vested interest in ensuring the integrity of clinical trial data and the safety of participants while clinical research is being conducted. Clinical research misconduct, such as fabrication or omission of data in reporting study results, puts all individuals in that trial at risk of harm. Fraud and other forms of misconduct impairs FDA’s goal to safeguard and promote public health by jeopardizing the accuracy of data provided to the agency.

To discover signals of suspected misbehavior, the FDA and other authorities rely on site inspections and whistleblowers. Due to the large number of product filings, the FDA can only inspect a small percentage of clinical trial sites. The determination of which sites to inspect can involve FDA inspectors’ judgement and experiences, suggestions by clinical and statistical reviewers, and CDER’s risk-based site selection tool. Under the original CRADA between …

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