Tag

Data Integrity

All articles tagged with #data integrity

Amgen keeps Tavneos on market as regulators review trial data and safety
business20 days ago

Amgen keeps Tavneos on market as regulators review trial data and safety

Amgen says it will not voluntarily withdraw Tavneos after an FDA request and will continue talks with regulators, even as the EMA re-examines Tavneos data integrity. The FDA is reviewing the original ChemoCentryx trial data and the drug’s risk-benefit profile due to rare hepatotoxicity, while Amgen asserts the underlying data are sound. Tavneos, approved in 2021 in the US and 2022 in the EU, remains a small but growing part of Amgen’s portfolio as it pursues milestones for other drugs like Uplizna and guides 2026 revenue higher after a 2025 showing of about $36.7B.

science1 month ago

Lung cancer immunotherapy study retracted over data integrity concerns

A Nature Retraction Note published January 14, 2026 states that the 2023 study on antibodies against endogenous retroviruses promoting lung cancer immunotherapy has been retracted after an institutional investigation found data integrity concerns. Specific issues include manipulated A549 cell-binding data in Figure 5c, potentially manipulated ADCC results in Figures 5d–e, and unverifiable source data for B cell and antibody quantitation (Figure 3c and Extended Data Fig. 5c). The Francis Crick Institute ruled that co-first author Kevin Ng was responsible for these analyses and recommended retraction. The authors apologized and plan to publish a revised, properly validated report; they note that TRACERx and CAPTURE clinical/genetic data are not indicated to be affected.

Political and Economic Shifts: Uncovering the Hidden Stories Behind Recent Headlines
opinion6 months ago

Political and Economic Shifts: Uncovering the Hidden Stories Behind Recent Headlines

The article discusses concerns about the potential manipulation and loss of trust in government statistics, highlighting historical examples, recent political interference, and the importance of reliable data for decision-making, emphasizing that while private data sources can supplement, they cannot replace official statistics as a public good.

"Fixing Peer Review: The Key to Better Science Publishing"
science-and-research-integrity1 year ago

"Fixing Peer Review: The Key to Better Science Publishing"

This week's Retraction Watch highlights include issues with hijacked journals, allegations of research misconduct, and the ongoing challenges in peer review and data integrity. Notable stories cover the surprising history of abstracts, the broken state of peer review, and controversies in bee waggle dance data. The Retraction Watch Database now includes over 49,000 retractions and tools like the Hijacked Journal Checker to combat fraudulent publications.

"Renowned Cancer Surgeon's Decade-Long Publication of Suspect Data Exposed"
health-and-science2 years ago

"Renowned Cancer Surgeon's Decade-Long Publication of Suspect Data Exposed"

The New York Times reports that 26 studies by a renowned cancer surgeon at Columbia University, Dr. Sam Yoon, have been flagged for suspicious data, including reused images of cancer cells and tumors. One study on stomach cancer was quietly withdrawn, and another retracted after inquiries. Memorial Sloan Kettering is investigating, and suspicions were initially raised by a British scientist. The story highlights broader concerns about the scrutiny of research publications and the use of AI-powered tools to uncover questionable research.

technology2 years ago

"Controversy Erupts as Linux Kernel Developers Discuss Priority-Based Shutdown"

A patch series proposing priority-based shutdown support for drivers/hardware in the Linux kernel has sparked a debate among developers. The focus is on prioritizing the shutdown of specific devices, particularly in scenarios like power loss, to prevent hardware damage. While some argue that this functionality is necessary to address questionable hardware designs, others question the need for it and suggest alternative solutions. The discussion revolves around whether such support should be included in the mainline Linux kernel and how it would benefit the automotive and embedded/industrial sectors.

healthcare2 years ago

BioXcel Therapeutics's Alzheimer's Drug Trial Success Overshadowed by Fraud Investigation and Site Issues

BioXcel Therapeutics announced that its experimental drug, BXCL501, has met the main goal of reducing acute agitation in Alzheimer's patients in a late-stage study. However, concerns over data integrity at one of the trial sites have marred the results. The drug showed statistically significant reduction in agitation after two hours compared to a placebo, but did not meet another key target at 30 minutes. BioXcel plans to submit an application to expand the drug's use later this year, but will also conduct an investigation into the data integrity issue.

FDA Implements Modernized Clinical Trial Standards with E6(R3) GCP.
health2 years ago

FDA Implements Modernized Clinical Trial Standards with E6(R3) GCP.

The FDA has released draft guidance with updated recommendations for good clinical practices (GCPs) to modernize the design and conduct of clinical trials, making them more efficient and flexible without compromising data integrity or participant protections. The draft guidance is aimed at incorporating rapidly developing technological and methodological innovations into the clinical trial enterprise and encouraging the use of innovative trial designs and health technologies. The FDA is requesting feedback on the draft recommendations and how they should be applied to increasingly diverse trial types and data sources.

New Study Develops Detection Tool to Identify Cheating Scientists and Fake Academic Papers.
science2 years ago

New Study Develops Detection Tool to Identify Cheating Scientists and Fake Academic Papers.

Researchers from the University of St Andrews suggest that auditing practices from the finance industry can be adapted to identify academic fraud. The paper looks at Benford's Law as a means of examining the relative frequency distribution for leading digits of numbers in datasets, which is used in the practice of professional auditing. The authors hope this paper will serve as an introduction to such tools for anyone wishing to challenge the integrity of a dataset, not just in financial data, but in any field that generates lots of data.