Study finds slight improvement in reporting of adverse reactions in drug trials over past 17 years

Researchers, including academics at the University of York, analyzed systematic reviews of 1,200 randomized controlled trials (RCTs) to assess whether the reports had improved over time.

However, the information the researchers needed to assess which side effects were reported (and how they were reported) was only included in less than half of the RCTs they analyzed.

Drug trials are conducted to give clinicians 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 adverse reactions in trials over the past 17 years. “

Dr Su Golder, study co-author, Department of Health Sciences

The study argues that many trials focus on the benefits rather than the adverse effects of the drug under test.

“There is also a tendency to focus only on damage that is either common or defined as serious, which results in hospitalization, disability or death. Still, other seemingly minor damage can be significant for patients – from diarrhea and insomnia to rashes and coughs. and muscle pain – can be important to capture, especially since it can prevent people from taking medication, ”added Dr. Golder.

The authors of the randomized controlled trials were also sometimes selective about the harm they reported, the study continued.

Dr Golder added: “We also need to know if a particular drug affects people differently, for example if it affects women more than men, or if a particular harm increases with age.”

The study concluded that the lack of notification or selective reporting of adverse reactions in published clinical trials can foster a false sense of safety and skew clinical and policy decisions and that the NHS, policy makers and patients all have need reliable information on benefits and side effects. of treatments to make good informed decisions.

In 2004, major new guidelines on the reporting of randomized controlled trials (RCTs) were published, with the aim of improving the reporting of adverse reactions in trials.

“It’s time to improve reporting of adverse effects in randomized controlled trials” is published in the Journal of Clinical Epidemiology.