New Delhi: Research on repurposed and new drugs as potential treatments for Covid-19 seem to be driven by “hype” and “anecdotes” rather than “informativeness and social value”, noted an analysis in the British Medical Journal.
The six authors of the report, titled ‘Producing and using timely comparative evidence on drugs: lessons from clinical trials for covid-19’ and published Friday, cited the case of the drug hydroxychloroquine as an example of ‘hyped’ research.
Hydroxychloroquine is a controversial anti-malarial drug that was used as part of Covid treatment in the early days of the pandemic. However, the World Health Organization’s multi-country Solidarity trial concluded that the drug was ineffective against the virus.
Stating that the research agenda “seems to be partly driven by hype and anecdote rather than informativeness and social value, skewing the amount of available data”, the BMJ analysis said, “A disproportionately large number of studies were launched to evaluate the antimalarial drugs hydroxychloroquine and chloroquine phosphate after the publication of a controversial uncontrolled study that received substantial attention.”
The study by French researchers, with a small sample size of 32 patients, had concluded that hydroxychloroquine “significantly reduced” the viral load. The study was non-randomized and the results were later refuted by the WHO trial.
“About one in every six studies registered on ClinicalTrials.gov has focused on these antimalarial agents,” the authors said, quoting a news report.
Covid exposed important flaws in evidence-based studies
The authors of the study — from the London School of Economics and Political Science, University of Oxford, University of Bern in Switzerland, Research Council of Norway and University of Oslo — pointed out that the Covid-19 drugs research has “exposed important flaws and failures in the current evidence ecosystem”.
Quoting various studies, analysis and news reports, they concluded that despite the large volume of studies undertaken to explore treatment options for Covid since the early days of the outbreak, “progress to date has been too slow”.
“Despite the availability of several large multi-arm trials, evidence on the comparative effectiveness of potential therapeutic alternatives has been delayed,” the authors said.
The researchers highlighted the limitations in the system for evaluating repurposed or investigational drugs for Covid-19.
“Firstly, global clinical research activity is fragmented. The drug trials rarely have similar design features…Even when randomised trials evaluate seemingly similar endpoints such as time to clinical recovery, outcome definitions and follow-up durations vary,” they said.
Studies also do not routinely adopt the gold standard of evaluating treatments.
“We estimate that fewer than one third of studies evaluating covid-19 therapeutics on ClinicalTrials.gov are randomised controlled trials, which are the gold standard for evaluating treatments. Many studies test investigational agents without a control group, which can be misleading as they provide no data on what would have happened in the absence of the treatment,” the analysis stated.
What should be done?
According to the researchers, the pandemic has highlighted “the opportunity to harness new collaborations among relevant stakeholders, including trialists, meta-analysts, guidance developers, regulatory agencies, health technology assessment bodies, and payers”.
The authors called for “greater collaboration among trialists, meta-analysts, and guidance developers to improve the evidence base for new treatments”.
While data sharing after trial completion is becoming more common, the analysis also highlighted that “data sharing is still not the norm”.
They pointed out that “according to ClinicalTrials.gov, Gilead (US pharmaceutical company) has no plans to release individual participant data from its phase III trials of remdesivir.”
“Determining the comparative effectiveness of drugs requires streamlining the design, analysis, reporting, and data sharing practices of clinical studies,” the report noted.
It suggests that the timely access to data from clinical trials can have several widely accepted benefits: “Such data could be re-analysed and combined with data from other studies to determine comparative effectiveness.”
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