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Animal Ethics Biosafety Human Research Ethics Research Integrity

(USA) NIH Fails to Enforce Rules for Reporting Clinical Trial Results – The Scientist (Amanda Heidt | August 2022)

Posted by Dr Gary Allen in Human Research Ethics on September 25, 2022
Keywords: Clinical trial, Institutional responsibilities, International, Research results, Researcher responsibilities

The Linked Original Item was Posted On August 18, 2022

Artistically worn US flag

A review by the US Office of Inspector General found that only about half of the scientists running clinical trials funded by the NIH in 2019 and 2020 appropriately recorded their findings in a federal database, as is legally required.

The US National Institutes of Health failed to ensure the timely reporting of results in roughly half of the clinical trials it funded in 2019 and 2020, including many overseen by NIH scientists, according to the findings of a new report released by the Department of Health and Human Services’ Office of Inspector General. In some cases, the agency allowed researchers who failed to meet these federal reporting requirements to launch new trials as well, drawing intense criticism from research transparency advocates and at least one former director of ClinicalTrials.gov, the federal database in which scientists are legally required to post updates on clinical research.

We are led to believe that the laws and regulations in the US means that their clinical trials in clinical research are some of the safest in the world.  They have had on the books for sometime that the results of clinical trials must be published.  We have heard many times how inefficient and dangerous it is if the results are not published.  So, it is sickening to hear that the US governance arrangements in this regard are not being enforced.  It is frankly disgusting to hear that the peak health research body in the States is failing in this way.  We have included links to 17 related items.

“NIH has severely let down patients and taxpayers since 2007, when trial reporting first became mandatory,” Till Bruckner, the founder of Transparimed, a group that tracks issues pertaining to clinical trial transparency, tells STAT News. “As this report documents, NIH for over a decade turned a blind eye to violations, and even rewarded law-breakers by handing them even more public money so they could run more trials with more patients.”

In 2018, the US Office of Inspector General (OIG) conducted a small probe to determine whether the NIH—which funds much of the clinical work conducted in the US—was sufficiently enforcing federal regulations that require researchers to publish their results within one year of an estimated or actual completion date. In a brief statementdescribing its justification for the new report, the OIG stated that “our preliminary review of data from ClinicalTrials.gov showed that most NIH-funded clinical trials that were completed in calendar year 2018 did not have their results posted.” The findings were troubling enough that the office began a more substantive analysis of trials carried out in 2019 and 2020.

NIH Fails to Enforce Rules for Reporting Clinical Trial Results
A review by the US Office of Inspector General found that only about half of the scientists running clinical trials funded by the NIH in 2019 and 2020 appropriately recorded their findings in a federal database, as is legally required.

Related Reading

(EU) New EU Protocol Aims to Improve Clinical Trial Transparency – TheScientist (Sophie Fessl | February 2022)

(US) How the FDA could save 2,700 clinical trials from becoming research waste – TranspariMED (Till Bruckner | January 2022)

(EU) European law could improve ‘scandalous’ lack of clinical trial data reporting – Science (Barbara Casassus | July 2021)

Against Research Waste – How the Evidence-Based Research paradigm promotes more ethical and innovative research – London School of Economics (Caroline Blaine, et al | February 2021)

(US) Following court ruling, NIH warns drug and device companies to post missing trial data – STAT News (Lev Facher | August 2020)

Too Many HF Trial Results Underreported or Never Published – TCTMD (L.A. McKeown | June 2020)

(US) Federal judge rules clinical trial sponsors must publish a decade’s worth of missing data – STAT (Lev Facher | February 2020)

(US) FDA and NIH let clinical trial sponsors keep results secret and break the law – Science (Charles Piller | January 2020)

European universities dismal at reporting results of clinical trials – Nature (Nic Fleming | April 2019)

Not Reporting Results of a Clinical Trial Is Academic Misconduct – ACP (Editorial | Joshua D. Wallach, MS, PhD; Harlan M. Krumholz, MD, SM | May 2019)

(US/UK) Data suggest US, UK universities fall woefully short on reporting clinical trial results – Endpoints News (Natalie Grover | March 2019)

Major medical journals don’t follow their own rules for reporting results from clinical trials – Science (Jocelyn Kaiser | February 2019)

(UK) Crackdown on unreported trials is good news for researchers – *Research (Till Bruckner | November 2018)

Opinion: Where’s the data? Missing trial results undermine pandemic preparedness – Devex (Till Bruckner | November 2017)

Grantees, Reveal Thy Findings: A Push By Funders for Transparency in Medical Research – Inside Philanthropy (Till Bruckner | July 2017)

Unpublished trials are a cancer at the core of evidence based medicine – Aftenposten (Ben Goldacre: October 2016)

New federal rules (US) target woeful public reporting of clinical trial results – STAT (Charles Piller September 2016)

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