Nature: A quarter of clinical trials may be suspected of falsification

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Nature: A quarter of clinical trials may be suspected of falsification

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Nature: A quarter of clinical trials may be suspected of falsification.

Medicine is plagued by unreliable clinical trials. How many clinical trial studies published in medical journals are allegedly falsified or fatally flawed?

In October 2020, John Carlisle reported an astounding assessment stat. John Carlisle was an anesthesiologist known for his ability to spot suspicious data in medical trials.

He is also editor of the journal Anaesthesia , and in 2017 he decided to search all manuscripts he had dealt with for randomized controlled trials (RCTs) , the gold standard for medical research .

Over the next three years, he pored over more than 500 clinical trial studies. In more than 150 trials, he obtained anonymized individual participant data (IPD) .

By studying the IPD data, he determined that 44% of these trials contained at least some flawed data, such as impossible statistics, incorrect calculations, or duplicated data or pictures. He believes that 26% of the papers were so pervasively flawed that the results could not be trusted, either because the authors were incompetent or because they falsified the data.

John Carlisle called these clinical trials “zombie” trials because they looked like real research, but closer scrutiny revealed that they were actually empty-handed. He is also surprised by the prevalence of such “zombie” trials, which he estimates could be as high as one in 10 clinical trials.

However, when he could not obtain the original data of the trial, he could only analyze it through the summary chart of the paper. At this time, he could only judge that 1% of the trials were “zombie” trials, and 2% of the trials had data defects. This also illustrates that without access to individual participant data (IPD) of trials , even experienced journal editors and reviewers may find it difficult to detect hidden flaws in trials.

John Carlisle, who published this survey in the journal Anaesthesia , also wrote in the report that journals should assume that all submitted papers are potentially flawed and that journal editors should review individual participant data (IPD) before publishing randomized controlled trials .

John Carlisle rejected every one of the “zombie” trials, but now, almost three years later, most of the “zombie” trials that he rejected have been published in other journals, and some of them have different data from the ones he saw. He is also emailing editors of the journals that published the trials, but he doesn’t expect to see any progress.

Do the findings of John Carlisle’s clinical trials in the field of anesthesiology also exist in other fields?

For years, many scientists, doctors and data sleuths have argued that fake or unreliable clinical trials are frighteningly common.

They searched for randomized controlled trials in various fields of medicine, such as women’s health, pain research, anesthesiology, bone health, and COVID-19, and found a large number of trial data that seemed statistically improbable.

Some have analyzed from their own experience that one in four trials is not credible, which may be an underestimate.

For example, Ian Roberts, an epidemiologist at the London School of Hygiene and Tropical Medicine, asserts that if you search for all randomized trials on a subject, about a third of the trials are fabricated.

In part, this is part of the problem with the notorious “paper mill,” in which academic journals in many fields have published tens of thousands of dubiously fake papers over the past decade, some of which are believed to have been “produced” in batches by third-party companies, so-called “paper factories.”

But unlike “article mills” who falsify fake papers, falsified or unreliable RCTs are especially dangerous because they not only involve medical interventions, but can also be sanctioned by inclusion in meta-analyses and systematic reviews that comb through the literature to assess evidence for clinical treatments.

Medical guidelines often cite such assessments, and doctors refer to them when deciding how to treat patients.

In a recent high-profile case of clinical trial falsification, Japanese bone health researcher Yoshihiro Sato , whose widely influential work was later found to have falsified data in dozens of trials of drugs or supplements that might prevent fractures, had 113 papers retracted.

His 27 retracted randomized controlled trials were cited by 88 systematic reviews and clinical guidelines, some of which were also referenced by Japanese recommended osteoporosis treatments.

However, it’s not just the individual investigators who falsified trial data that are worrisome.

In some fields, a large number of randomized controlled trials from different research groups may not be reliable. For example, during the COVID-19 pandemic, a series of randomized controlled trials have been conducted on whether ivermectin can treat COVID-19.

But it was later discovered that many of these studies had data flaws, and some of them have been retracted. A systematic review updated in 2022 concluded that more than 40% of these randomized controlled trials of ivermectin for the treatment of COVID-19 were not credible.

Maternal and child health appears to be another area fraught with problems. Worldwide, 14 million pregnant women experience postpartum hemorrhage every year, and about 70,000 of them die as a result, which is also the main cause of death among pregnant women worldwide. Tranexamic acid is a hemostatic drug that

Ian Roberts, an epidemiologist at the London School of Hygiene and Tropical Medicine, has investigated the trial evidence for the use of tranexamic acid for postpartum haemorrhage.

His investigation revealed that many of the 26 randomized controlled trials involving tranexamic acid had serious flaws, including plagiarism, inconsistent data, lack of ethical approval, and some studies did not achieve true random allocation.

When he asked some of the authors for more trial details and raw data, he usually didn’t get a response, or was told that the trial records were nowhere to be found or lost due to stolen computers.

Fortunately, in 2017, a large, high-quality multicentre trial co-conducted by Ian Roberts confirmed the effectiveness of tranexamic acid in the treatment of postpartum hemorrhage in pregnant women.

In general, many of the clinical trials published in medical journals are suspected of being falsified or fatally flawed. These problems are having serious consequences.

Therefore, some researchers have urged that clinical trials should be more scrutinized.

For example, the journal Anaesthesia has begun to require authors of papers to provide individual participant data (IPD) for clinical trials .

And John Carlisle believes that in order to solve this problem, we must start from the source.

When these fake clinical research papers are mass-produced, it means that the fire has started, and it is necessary to draw fire from the bottom of the pot.

Original link :
https://www.nature.com/articles/d41586-023-02299-w

Nature: A quarter of clinical trials may be suspected of falsification

(source:internet, reference only)

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