Cambridge, MA - FDA and its stakeholders have an interest in assuring the integrity of clinical trial data and the protection of participants during the conduct of clinical research. Misconduct in clinical research, including, but not limited to the falsification or omission of data in reporting research results, places all subjects in that trial at possible safety risk. Fraud jeopardizes the reliability of data submitted to FDA, and undermines the Agency’s mission to protect and promote public health. FDA and other regulators rely on whistleblowers and site inspections to detect signs of possible misconduct. Due to the volume of product submissions, FDA can only inspect a small proportion of clinical trial sites. The determination of which sites to inspect can involve recommendations by clinical and statistical reviewers, CDER’s risk based site selection tool and FDA inspectors’ judgment and experiences. This CRADA explores a data driven approach to selecting sites which exhibit data anomalies indicative of fraud, misconduct or sloppiness. Under this CRADA, FDA and CluePoints, Inc. will develop and test enhancements to CluePoints existing software to produce an ordered list of “anomalous sites”, i.e. sites whose data are highly inconsistent with data from other sites; explore “moderators of treatment effect”, i.e. factors such as center, region, or country that have a statistically significant impact on the magnitude of treatment effect; add statistical tests and models to those already in the existing software; refine the scoring system used to identify outlying centers; add an exploratory tool to identify moderators of treatment effect; test and implement the software in a high performance computing environment; and develop a user-friendly interface for use by medical reviewers and other interested parties at FDA. Anticipated benefits to the FDA of the CRADA’s data driven approach include the detection of anomalous sites which may have escaped detection previously, rapid turnaround of results, the ability to determine the nature and extent of data anomalies, and the ability to explore the interaction of various factors with data quality. These benefits are expected to not only accrue to the site inspection process and improve data quality for all reviewers, but may also inform the efforts of clinical and statistical reviewers to conduct sensitivity analyses, subgroup analyses and site by treatment effect explorations. For further information on CluePoints, please visit www.CluePoints.com About CluePoints CluePoints is a Central Statistical Monitoring solution designed and perfected over the last 10 years. It employs unique statistical algorithms to determine the quality, accuracy, and integrity of clinical trial data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints is deployed to support traditional on-site monitoring and to drive a risk-based monitoring strategy. The value of using CluePoints lies in its powerful and timely ability to identify anomalous data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and a significant reduction in overall regulatory submission risk.
SCOPE Summit 2025: Enhancing the Patient Experience Through Site Centricity
February 12th 2025In an interview with ACT senior editor Andy Studna at SCOPE Summit, Ashley Davidson, vice president, product lead - sponsor tech strategy, Advarra, highlights the need for more site-centric approaches in study startup.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.