Gaps in the way harms are reported in clinical trials are impacting our understanding of intervention pros and cons, researchers say...
Professor Mark Morgan, Chair of RACGP Expert Committee – Quality Care, told newsGP there is a moral and ethical imperative for research to be conducted well.
‘There is huge waste in research with some estimates that 85% of research is wasteful. Some of the sources of waste include failure to review what has been done before,’ he said.
‘Some projects are designed poorly. If researchers already believe they know the outcome it is all too easy to fail to look for harms from interventions.
‘Trial registries help to ensure that negative results cannot be so easily hidden away by failure to publish. Much work has been done to address poor research reporting using checklists to ensure all important design features and outcome measures are reported.’..
One potential reason suggested by Professor Morgan is that systems for reporting adverse events are patchy and rely on clinicians and patients making structured reports to oversight authorities.
‘When the anticipated number of adverse events are compared to the actual number of reports received, there is a huge gap signifying underreporting,’ he said.
Professor Morgan believes there is a ‘pressing need’ to investigate, design and test better adverse effect monitoring for health interventions and has suggestions for improved reporting.
‘I believe that analysis of large, anonymised datasets could help identify unexpected adverse effects from pharmaceutical and non-pharmaceutical interventions,’ he said.
‘It would also be beneficial to look at ways to lower the barriers to reporting adverse effects. There are examples of text-back surveys that can pick up potential adverse effects from immunisations that do this well.
‘Individual reports might not be as thorough in these surveys compared to traditional structured adverse reporting, but with far more responses the information obtained is likely to be far better.
‘Another approach that is starting to be used in countries with effective primary healthcare data governance uses the power of bigdata to automatically identify harms following an intervention.
‘General practice is well placed to engage in novel adverse event monitoring, but we cannot be expected to self-fund the work.’
Harms from health interventions
Research reporting deficits