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Negligence of clinical trial registries undermines Covid-19 medical research

A study published today warns that getting a comprehensive overview of Covid-19 clinical trials is difficult due to flawed clinical trial registrations and weaknesses in the global trial registry infrastructure.

The 'living systematic review' by the Infectious Diseases Data Observatory (IDDO) analyses all Covid studies listed on trial registries as of early April 2020. It covers 728 studies, including 294 randomised controlled trials (RCTs).

Between them, these studies assess 109 pharmacological interventions or advanced therapy medicinal products.

The study cautions that “the majority of investigations in the first three months of the outbreak were small studies with unique treatment arms, likely to be unpowered to provide solid evidence.”

For example, the median number of participants included in RCTs was just 134 patients.

“[T]his review illustrates a lack of coordination and duplication of effort that will ultimately delay definitive results of key interventions… The proliferation of such studies will likely result in underpowered studies individually unable to generate meaningful evidence for policy makers.”

In theory, the global network of clinical trial registries (ICTRP) coordinated by the World Health Organisation should provide a clear overview of who is studying which potential treatments. In practice, the study found, trial registries largely fail to deliver on this promise.

According to the study team:

“Robust extraction of the results described above was hindered by the incompatible and inconsistent data fields, categorisation, and naming conventions across the many source trial registries. This lack of harmonisation limits the fidelity of results pooled across these sources… The eligibility of pregnant women was unknown in roughly half of studies and the eligibility of the other at-risk groups was unable to be ascertained from the study registry in over 75% of registered studies.”

“While the rationale of the WHO International Standards for Clinical Trial Registries is undisputed, our review highlights substantial heterogeneity, inconsistencies and perceived errors in the recorded information across source country and regional registries. For example, as different trial registries have different classification systems for study design, there were 76 unique descriptions of study design as collected by the WHO ICTRP [network], with 66 studies containing no information.”

“While the current WHO International Standards for Clinical Trial Registries outlines minimum reporting guidance of what should be collected in registration records, consensus on how these details are collected limits the current utility of this information source alone. For this reason, caution should be raised in the interpretation of many initiatives currently presenting the raw WHO ICTRP registry data. Without harmonisation of data fields and common taxonomies and definitions, records across different source records do not align.”

To overcome these problems and produce reliable results, IDDO’s team had to manually review source registry records, and manually extract and harmonise data. IDDO told TranspariMED that over 20 researchers were involved in extracting and cleaning up data from registries.

The study is is still awaiting peer review

Till Bruckner, founder of TranspariMED, said:

“Trial registries were set up to provide a clear and comprehensive overview of research into potential treatments for Covid and other diseases. Research funders in particular depend on registry data to identify areas in which more research is urgently needed, and to avoid duplicating their efforts.”

“This study illustrates the high price we are paying today for the persistent neglect and underfunding of trial registries by policy makers. Lax oversight at the national level has left considerable data gaps in trial registries, and what data exists cannot easily be aggregated across registries. These problems will only get worse as the number of Covid trials continues to grow.”

“It is simply unbelievable that in the year 2020, in the midst of a global pandemic, highly skilled medical researchers have to spend weeks manually sifting through data to provide a basic overview of the global Covid research landscape. Clinical trial registries should be the information superhighways of the global medical research infrastructure, but at present all we have is a tangle of badly maintained lanes riddled with potholes. Policy makers urgently need to invest the very modest amounts required to create an information infrastructure fit for the twenty-first century.”

The study team was led Brittany J. Maguire of the Infectious Diseases Data Observatory (IDDO) in Oxford. IDDO is keen to hear from, collaborate and coordinate efforts with other research groups working on similar projects.

The team will continue updating its database over the coming months. Visit the IDDO’s online data hub and interactive platform by clicking on the image below:

An extensive list of other Covid clinical trial databases and information sources can be found on the TranspariMED website.

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