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Animal Ethics Biosafety Human Research Ethics Research Integrity

Medicine is plagued by untrustworthy clinical trials. How many studies are faked or flawed? – Nature (Richard Van Noorden | July 2023)

Posted by Connar Allen in Human Research Ethics, Research Integrity on August 16, 2023
Keywords: Breaches, Clinical trial, Data management, Journal, Medical research, Research results

The Linked Original Item was Posted On July 18, 2023

A horrific zombie lunges at us.

Investigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up, warn some researchers. They urge stronger scrutiny.

How many clinical-trial studies in medical journals are fake or fatally flawed? In October 2020, John Carlisle reported a startling estimate1.

Like the zombies of pulp horror, flawed clinical trials can do devastating and deadly damage.  It is important they are identified and expunged from the academic literature.  This piece describes the marvellous work of John Carlisle.  His analysis of the clinical data that he reviewed is truly sobering and scary.  Institutions, funding bodies, learned societies and publishers need to play their part in protecting society from this scourge.

Carlisle, an anaesthetist who works for England’s National Health Service, is renowned for his ability to spot dodgy data in medical trials. He is also an editor at the journal Anaesthesia, and in 2017, he decided to scour all the manuscripts he handled that reported a randomized controlled trial (RCT) — the gold standard of medical research. Over three years, he scrutinized more than 500 studies1.

For more than 150 trials, Carlisle got access to anonymized individual participant data (IPD). By studying the IPD spreadsheets, he judged that 44% of these trials contained at least some flawed data: impossible statistics, incorrect calculations or duplicated numbers or figures, for instance. And 26% of the papers had problems that were so widespread that the trial was impossible to trust, he judged — either because the authors were incompetent, or because they had faked the data.

Carlisle called these ‘zombie’ trials because they had the semblance of real research, but closer scrutiny showed they were actually hollow shells, masquerading as reliable information. Even he was surprised by their prevalence. “I anticipated maybe one in ten,” he says.

Medicine is plagued by untrustworthy clinical trials. How many studies are faked or flawed?
Investigations suggest that, in some fields, at least one-quarter of clinical trials might be problematic or even entirely made up, warn some researchers. They urge stronger scrutiny.

Related Reading

Lessons from the COVID-19 pandemic and recent developments on the communication of clinical trials, publishing practices, and research integrity: in conversation with Dr. David Moher (Papers: Daeria O. Lawson, et al | August 2022)

‘Zombie papers’ just won’t die. Retracted papers by notorious fraudster still cited years later – Science (Jeffrey Brainard | June 2022)

Unethical studies of ivermectin for covid-19 (Editorial: Gideon Meyerowitz-Katz, et al | April 2022)

Stamp out fake clinical data by working together – Nature (Lisa Bero | January 2021)

(US) Federal Agencies Must Investigate Serious Regulatory, Ethical Lapses in Reckless Epilepsy Clinical Trial Funded by NIH – Public Citizen (June 2021)

Misrepresenting “Usual Care” in Research: An Ethical and Scientific Error (Papers: Ruth Macklin, Charles Natanson | January 2020)

Make reports of research misconduct public – Nature (C. K. Gunsalus | June 2019)

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