Clinical Trial Reliability Questioned
The reliability of clinical trials has come under fire after it has been suggested that recent trials may contain wrong or falsified data.
According to a review of thousands of papers published in leading medical journals, dozens contain suspicious statistical patterns, says The Guardian. The study, carried out by John Carlisle, a consultant anaesthetist at Torbay Hospital used statistical tools to identify anomalies hidden in the data.
He reviewed data from 5,087 clinical trials published during the past 15 years in two prestigious medical journals, Jama and the New England Journal of Medicine, and six anaesthesia journals. In total, 90 published trials had underlying statistical patterns that were unlikely to appear by chance in a credible dataset.
As a result of the findings, Dr Andrew Klein, editor in chief of Anaesthesia, has called for the studies identified as potentially flawed to be reviewed urgently. “It’s very scary that we may have been treating patients based on false evidence,” he explained. “It may be the case that certain treatments may need to be withdrawn from use.”
The process involved works by comparing the baseline data, such as the height, sex, weight and blood pressure of trial participants, to known distributors of these variables in a random sample of the populations. A sign of errors could be flagged up if the baseline data differs significantly from expectation, in turn suggesting tampering on the part of the researcher as if datasets have been fabricated they are unlikely to have the right pattern of random variation.
The review includes a full list of the trials in question, allowing Carlisle’s methods to be checked but also potentially exposing the authors to criticism. Previous large-scale studies have avoided singling out authors.
The relevant journal editors were informed last month, and the editors of the six anaesthesiology journals name in the study said they plan to approach the authors of the trials in question, and raised the prospect of triggering in-depth investigations in cases that could not be explained.
A spokeswoman for the New England Journal of Medicine commented they had not had access to the list of papers cited until publication, but the editors were taking the issue seriously and would carefully review all information.
Editor in chief of Jama, Howard Bauchner, concluded, “We receive numerous allegations about various issues related to the articles we publish. After we assess the validity of the allegation, we will determine next steps. We certainly believe authors have a right to respond to allegations that are important.”