Jacinta Bowler
While global clinical trial reporting guidelines are undergoing an update for the first time in a decade, a new study has found that the reporting of ‘harms’ – adverse events – in clinical trials are often inadequate.
“This problem is global,” says Dr Christina Abdel Shaheed, from the School of Public Health at the University of Sydney, and the lead researcher of the new study.
“We see the problems occurring even in some of the best medical journals. It’s something that needs to be tightened and strengthened across the board.”
The paper which has been published in the Medical Journal of Australia, took a global view by looking at systematic reviews of tens, or hundreds of trials, or policy documents, to get an understanding of the scale of the problem.
Read more: How do clinical trials work?
The team found many trials are not reporting on harms from clinical trials in a systematic manner, and some – particularly those that don’t involve drugs – are not reporting on harms at all.
“There’s a perception [among researchers] that the treatment that they’re evaluating is potentially low risk, and therefore they don’t have to collect information — that’s actually inaccurate,” says Abdel Shaheed.
“Basically, any intervention or any treatment should have information on harm being collected and reported in the published reports — we’re seeing that it’s absolutely not happening.”
The researchers also found that papers regularly failed to specify between adverse events — where something goes wrong in the trial but is not necessarily related to the treatment — or adverse reactions — where something about the treatment has caused the harm. This is particularly a problem when there’s limited information on serious adverse events, for example if someone ends up in hospital or dies.
“People need information on both benefits and harms to be able to make a decision about whether or not they’re going to use that treatment,” says Abdel Shaheed.
“At the moment clinical trials do quite a good job at reporting on the benefits, but not such a good job reporting on the harms.”
Currently, although the Therapeutic Goods and Administration regulates it, Australia does not have an easy way to access adverse reactions or events in clinical trial data. This new research suggests that the problem is not only at these top levels but all the way down to collection of the results.
The researchers have proposed some changes to help document any harms from clinical trials, but stress that these need to occur at the very beginning of the process.
Some of the suggestions made in the paper include that there be a standard reporting strategy for all trials evaluating medicines or medical devices, psychological or behavioural interventions, surgical procedures and physical therapies.
Other suggestions include:
-Including all data on proportion of people experiencing, and frequency of, serious and non-serious adverse events that occur during and after the therapy or medication has been administered.
-Attribute the cause of severe adverse events.
-Where feasible, identify cause of non-serious adverse events.
-Correctly labelling adverse events or serious adverse events caused by the treatment as an adverse reaction or serious adverse reactions