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Harms in research need better reporting: Study
Gaps in the way harms are reported in clinical trials are impacting our understanding of intervention pros and cons, researchers say.
The reporting of adverse events and reactions in clinical trials is often insufficient or completely lacking, new research suggests.
Research from the University of Sydney has found that the reporting of adverse events and reactions in clinical trials is often insufficient or completely lacking.
Published in the Medical Journal of Australia, the team outline that information on harms is absent or reported inconsistently in clinical trials and there is no universal definition of ‘harms’ that applies to all treatments.
They say harms may be characterised by adverse events and adverse reactions. Both refer to untoward medical occurrences in a trial participant, but the second term presumes causation and is reserved for events directly attributed to the investigated treatment.
Lead author Dr Christina Abdel Shaheed told newsGP that after carrying out multiple systematic reviews of medicines and non-drug treatments, it was ‘quickly becoming apparent’ that the reporting of harms in clinical trials was inconsistent.
‘We decided to do this study to raise awareness about this issue, outline the scope of the problem, and provide specific guidance on how reporting of harms in clinical trials can be strengthened,’ she said.
‘There are many benefits to being involved in clinical trials – they are an invaluable part of the development of new medical treatments and therapies.
‘Transparent and accurate reporting of harms is vital in maintaining public trust in science and clinical research. Improvements in the reporting of harms are important to give participants more confidence in their involvement.’
The severity of adverse events vary widely – from mild harms, such as headaches, to serious adverse events that result in hospitalisation, disability, increasing the length of hospitalisation, birth anomaly or death.
According to the paper, the lack of harms reporting in clinical trials that do not involve medicines is an under-recognised problem, and especially common in physical, psychological and behavioural trials.
A 2022 review of psychological interventions for chronic back pain found only about 20% of the 97 trials included reported adverse events and most reported that no adverse events occurred.
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.’
The CONSORT checklist is the current reporting guideline in place for randomised controlled trials. But while this encourages the reporting of harms in clinical trials, reporting practices are inconsistent globally and details of the type of harms and cause of serious harms is absent or inconsistent in published trial reports.
‘A possible contributor to the problem is that policy documents, for example from the National Health and Medical Research Council [NHMRC], define adverse events with regard to administering a medicine or medical device,’ Dr Shaheed said.
‘There needs to be a broader definition of harms that applies to all treatments.’
‘Improvements in the reporting of harms is important to give participants more confidence in their involvement. It also creates more transparent evidence to guide safe and effective use of treatments for both the scientific community and for the public.
‘The CONSORT checklist mandates reporting of harms in all clinical trials, irrespective of the type of intervention. It is unclear why many trials of non-drug intervention are not reporting on harms.’
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.’
The MJA paper also provides recommendations aimed at standardising harms reporting across all types of treatments being tested, including:
- Standard reporting strategies for all trials evaluating medicines, medical devices, psychological or behavioural interventions, surgical procedures and physical therapies
- Reporting on the proportion and frequency of people experiencing serious and non-serious adverse events that occur during and after the therapy or medication has been administered.
- Attributing the cause of adverse events.
- Correctly labelling adverse events or serious adverse events caused by the treatment
Checklists for all study types can be found
here.
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