18 July 2023 – www.nature.com
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.
Richard Van Noorden
How many clinical-trial studies in medical journals are fake or fatally flawed? In October 2020, John Carlisle reported a startling estimate1.
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.
When Carlisle couldn’t access a trial’s raw data, however, he could study only the aggregated information in the summary tables. Just 1% of these cases were zombies, and 2% had flawed data, he judged (see ‘The prevalence of ‘zombie’ trials’). This finding alarmed him, too: it suggested that, without access to the IPD — which journal editors usually don’t request and reviewers don’t see — even an experienced sleuth cannot spot hidden flaws.
“I think journals should assume that all submitted papers are potentially flawed and editors should review individual patient data before publishing randomised controlled trials,” Carlisle wrote in his report.
Do Carlisle’s findings in anaesthesiology extend to other fields? For years, a number of scientists, physicians and data sleuths have argued that fake or unreliable trials are frighteningly widespread. They’ve scoured RCTs in various medical fields, such as women’s health, pain research, anaesthesiology, bone health and COVID-19, and have found dozens or hundreds of trials with seemingly statistically impossible data. Some, on the basis of their personal experiences, say that one-quarter of trials being untrustworthy might be an underestimate. “If you search for all randomized trials on a topic, about a third of the trials will be fabricated,” asserts Ian Roberts, an epidemiologist at the London School of Hygiene & Tropical Medicine.
FULL ARTICLE – https://www.nature.com/articles/d41586-023-02299-w