An article recently published in the Anaesthesia journal raises fresh concerns about the reliability of data obtained from clinical trial studies.

John Carlisle, a consultant anaesthetist at Torbay Hospital scrutinised statistical patterns across 5078 randomised controlled trials published in eight leading scientific journals between January 2000 and December 2015: Anaesthesia; Anaesthesia and Analgesia; Anaesthesiology; British Journal of Anaesthesia; Canadian Journal of Anaesthesia; European Journal of Anaesthesiology; Journal of the American Medical Association and the New England Journal of Medicine. His investigation revealed inconsistencies in the dataset of the studies published in these journals.

Possible explanations advanced for the anomalies include fraud, unintentional error, correlation, stratified allocation and poor methodology. Editors of the New England Journal of Medicine and Anaesthesia have expressed their intention to review all the studies that have been identified as potentially flawed.

The findings of Carlisle’s study calls into question the scientific integrity of clinical trials and raises serious concerns regarding the health and safety of patients who are subjected to medical treatment on the basis of their findings.

Gene Matthews, a partner at law firm Leigh Day who specialises in clinical trial claims, said:

“As an enthusiastic advocate for the significant societal benefits that stem from properly regulated and conducted clinical trials, the findings of this study are extremely worrying and cast doubt on the trust and confidence that can be placed in the veracity of clinical trial findings.

“Moreover, the potential implications for patients are far-reaching because the outcomes of clinical trials are used by pharmaceutical companies to demonstrate the clinical effectiveness of a particular drug and ultimately obtain regulatory approval so that it can be used by patients.

“The issues raised must be looked into, as a matter of priority, by the various regulatory authorities”.