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 – 5 June 2024: 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 FDA and CluePoints, software was developed and CluePoints’ existing software was enhanced to produce a ranked list of anomalous sites to help prioritize site inspection(s) for FDA inspectors.

As a result of the original CRADA, the CluePoints software was deployed in the FDA high performance computing environment, new statistical tests were developed to detect anomalous sites, the site ranking algorithm was improved, as well as the user interface for use by reviewers and others at FDA was also improved. Additionally, significant progress was made in the detection of modulators of treatment effect, i.e., factors such as center, region, or country that have a statistically significant impact on the magnitude of treatment effect.

Under this new proposed CRADA, FDA and CluePoints, Inc. will focus on two primary objectives:

  • The first objective is to develop and enhance CluePoints SMART™ software to address a broader range of regulatory issues and concerns. The CRADA will leverage date/time data which takes on greater significance with decentralized trials (DCT) and the increasing use of electronic clinical outcome assessment (eCOA) and electronic patient reported outcomes (ePRO) technologies. Further developments will be added to improve the detection of duplicate patients. The proposed CRADA will explore how Artificial Intelligence and Machine Learning (AI/ML) algorithms can further support anomaly detection. Finally, further research will be carried out to explore the moderators of treatment effect and develop a software solution that can be deployed within the FDA environment.
  • The second objective is to improve and enhance how SMART™ software and the CluePoints monitoring platform may be adapted to better support FDA processes related to anomaly detection, review and follow-up, as well as site selection for FDA inspections.


Anticipated benefits of the CRADA to the FDA include improved detection of anomalous sites, the ability to explore the interaction of various factors with data quality and their potential impact on treatment effect, and the ability to streamline the processes of data review and site selection for inspection at FDA.

For more information about the new CRADA between CluePoints and FDA, please visit www.cluepoints.com.

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About CluePoints

CluePoints is the premier Risk-Based Quality Management (RBQM) and Data Quality Oversight Software provider. We are leveraging the potential of artificial intelligence using advanced statistics and machine learning to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA, EMA, and ICH E6 (R2), CluePoints is deployed to support central and on-site monitoring, medical review, quality risk management and to drive a holistic Risk-Based strategy in all trials. Coupled with thought leadership and consulting expertise to aid pre-study risk assessment, identification of risk controls and solution implementation, you now have everything you need to adhere with global regulatory guidance. The result is positive clinical development outcomes, increased operational efficiency, lower costs and reduced regulatory submission risk as part of the industry paradigm shift to RBQM.