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Duplicated or low-quality studies wasting research: Experts


Doug Hendrie


18/05/2020 4:22:17 PM

The world’s health researchers have moved rapidly to tackle the coronavirus pandemic – but with varying results, according to experts.

COVID-19 research
More than 1000 COVID-19 trials have been registered with the US National Library of Medicine.

The launch of thousands of new studies and trials has seen many positive outcomes, such as increased collaboration, better open access to COVID-19 studies and rapid approvals.
 
But, according to three Bond University experts, much of this effort has unfortunately been wasted on low-quality research.
 
In a British Medical Journal editorial, Professor of Evidence Based Practice Paul Glasziou, Assistant Professor Sharon Sanders, and Professor of Clinical Epidemiology Tammy Hoffman have argued that many existing problems in medical research have worsened during the pandemic.
 
‘Before the pandemic, it was estimated that up to 85% of research was wasted because of poor questions, poor study design, inefficiency of regulation and conduct, and non or poor reporting of results,’ they write.
 
‘Many of these problems are amplified in COVID-19 research, with time pressures and inadequate research infrastructure contributing.’
 
More than 1000 COVID-19 trials have been registered with the US National Library of Medicine.
 
‘Though some will provide useful information, many are too small and poorly designed to be helpful, merely adding to the … noise,’ the experts write.
 
For example, of the 145 trials of hydroxychloroquine – famously hyped as a coronavirus ‘cure’ by US President Donald Trump – 32 have planned sample sizes of fewer than 100, while 10 have no control group, and 12 are comparative but non-randomised, while outcome measures vary widely.
 
The point has been reinforced by a Nature editorial pointing out that poorly designed or small studies can cause ‘clinical chaos’, demonstrated by trials of experimental antiviral drug remdesivir producing widely differing results.
 
‘It’s important to move quickly to larger, collaborative trials – ones that span borders and share expertise – that have a greater chance of showing what really works,’ the Nature editorial states.


Professor Glasziou and his co-authors also point out issues with the way medical researchers are focusing too heavily on prospective ‘cures’ at the expense of research into the only currently proven ways of reducing spread, namely non-medical interventions such as social distancing and better hand hygiene, which the authors claim is a ‘woeful imbalance’.
 
‘Despite non-drug interventions being the mainstay of current mitigation, we could find just two trials of masks on ClinicalTrials.gov and none examining social distancing, quarantine effect or adherence, hand hygiene, or other non-drug interventions,’ they write.
 
Professor Glasziou and his co-authors note that while the sharply increased use of preprints have provided useful early access to results, there have been issues with the way these early results are reported.
 
‘In systematically reviewing the proportion of asymptomatic COVID-19 cases, we found the sample frame of most studies was unclear, missing cases were undocumented, and “asymptomatic” was undefined,’ they write.
 
‘Access to preprints has also led to irresponsible dissemination as flawed studies are picked up by the media.
 
‘The preprint of the first reported study of hydroxychloroquine on 20 March 2020 – a non-randomised study of 46 patients with inappropriate analyses  – has been cited 520 times, while a larger, randomised trial of hydroxychloroquine posted on MedRxiv on 14 April showing no benefits has received far less attention.
 
‘The unbalanced media attention to the first study has triggered a wave of what is likely to be largely unnecessary or misdirected research.’
 
Haste is leading to waste and duplicated effort, the authors note.
 
The large number of registered trials of hydroxychloroquine is one example, while five systematic reviews of the use of face masks in the community are taking place.
 
‘Existing research infrastructure to enable collaboration and communication is extremely limited, with system cracks made more apparent by the pace and volume of COVID-19 research,’ Professor Glasziou and his co-authors write.
 
The authors suggest a way to reduce duplication could be a centralised portal hosted by the World Health Organization as a way to catalogue all ongoing research and synthesis
 
They also praise the Coalition for Epidemic Preparedness Innovations (CEPI) as a counterbalance to these trends, given CEPI is developing and testing eight vaccine candidates at the same time.
 
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Dr Daniel Peter Ewald   19/05/2020 7:49:38 AM

The imbalance between the number of therapy trials vs non-medical protection trials is a recurrent theme is public health medicine. It is generally much more difficult to do public health trials with proper control groups.