Researchers, including academics from the University of York, analyzed systematic reviews of 1,200 randomized controlled trials (RCTs) to assess whether reporting has improved over time. However, the information the researchers needed to assess which side effects were reported (and how they were reported) was found in less than half of the RCTs they analyzed.
Co-author Dr. Su Golder of the Department of Health Sciences said, “Drug trials are being conducted to provide clinicians with information about the benefits and side effects of treatments. Our study shows that, disappointingly, there has been only a slight improvement in the reporting of side effects in studies over the past 17 years. ”In 2004, important new guidelines were published on the reporting of RCTs with the aim of increasing the reporting of side effects in studies improve.
The new study argues that many studies focus on the benefits rather than the side effects of the drug under study.
“There is also a tendency to focus only on damage that is either common or defined as severe [enough to] Cause hospitalization, disability, or death. Still other seemingly minor harm that can be important to patients – everything from diarrhea and insomnia to rashes, coughs, and muscle pain – can be important to capture, especially as it can prevent them from taking medication, ”added Golder .
Those who reported the results of RCTs were also sometimes selective as to which harms they reported, the study said.
Golder noted: “We also need to know whether a certain drug affects people differently – for example, whether it affects women more than men or whether certain damage has increased with age.”
The study concluded that the absence or selective reporting of adverse reactions in published clinical trials may create misleading safety beliefs and misinform clinical and policy decisions, and that the UK’s National Health Service, policy makers and patients all have reliable information about it Treatment benefits and side effects to help you make good, informed decisions.
Edited by Gary Cramer