New report highlights fragmentation, duplication and transparency concerns in Spanish Covid trials

Researchers in Spain have launched a total of 123 Covid-related clinical trials, a new report published today by Universities Allied for Essential Medicines (UAEM) Spain shows.


The report finds strong indications that Spanish COVID research efforts lack coordination, and that there has been considerable overlap in research agendas. As a result, many Spanish trials – including publicly funded trials – are likely not to make any contribution to the discovery of effective treatments for COVID patients, and may thus become research waste.


COVID Clinical Trials in Spain - Fragmen
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Download • 427KB

Research waste warning signs in Spain include:

  • Fragmentation: Over 123 Covid-related clinical trials were launched in Spain over a period of only seven months.

  • Duplication: Numerous Spanish trials evaluate the same treatment options; 21 trials received approval to investigate the drug hydroxychloroquine.

  • Lack of transparency: There are indications that the results of many Spanish COVID trials may never be made public.


In addition, the UAEM report flags weaknesses in the design and operation of the Spanish trial registry REec.


A report published earlier this year by Spanish health group Salud por Derecho flagged similar concerns, including missing trial results and large data gaps. Under Spanish law, trial results have to be made public in the REec, but it appears that this law is not being enforced. This is especially concerning as many Spanish Covid trials are likely to be terminated early and never report their results in academic journals.


REec is a stand-alone national trial registry that is not linked to the global WHO network of primary trial registries. While it is largely unknown among international researchers, REec has the potential to provide an overview of the national clinical trial landscape. Similar national registries exist in other European countries, including in Germany.


It is unclear whether the added value such stand-alone national registries provide justifies the double registration and reporting burden they impose on medical researchers, who are additionally expected to register their clinical trials on a WHO primary registry.


UAEM’s report provides the following recommendations:


  • Spanish policy makers should review national COVID clinical research efforts in order to inform future research policy

  • Public research funbding agency Instituto de Salud Carlos III should sign up to the WHO Joint Statement and ensure that all clinical trials funded with public money make their results public

  • National medicines regulator AEMPS should improve data quality and results reporting on the REec registry


TranspariMED has endorsed the report and its recommendations.


Click here to access the full report:

COVID Clinical Trials in Spain - Fragmen
.
Download • 427KB





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