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Large data gaps found in Spanish clinical trial registry

The Spanish national clinical trial registry is riddled with holes, a report released today warns. Results are verifiably missing for 122 trials, in violation of a Spanish law that requires companies and institutions running trials to upload results within a year of completing a trial.

The true number of overdue missing results is likely to be far higher, because registry entries for 1,499 trials marked as completed do not include a completion date, making it impossible to tell which trials are in breach of the one year reporting deadline.

In total, 70% of all completed trials lack this key data point, suggesting that Spain’s medicines regulator AEMPS is failing to monitor data quality.

In addition, the records for over a thousand trials are missing information on the intervention and the active ingredient involved, leaving unclear what treatments researchers were investigating in the first place.

Till Bruckner, founder of TranspariMED, said:

“A badly managed national trial registry is worse than no national trial registry at all because it imposes additional red tape and compliance costs on medical researchers without providing significant benefits to patients, taxpayers or the medical research community."

"For example, the Spanish registry clearly fails to fulfil its promise to bring more transparency into medical research because Spanish authorities are not enforcing national disclosure laws. Today’s report shows the urgent need for a constructive dialogue between national regulators, research institutions and patient groups about the purpose and management of this type of medical database.”

The Spanish Clinical Studies Registry (Registro Español de Estudios, REec) does not form part of the WHO primary registry network, and is not linked to the European drug trial registry EudraCT. Therefore, scientists outside Spain are unlikely to find – let alone use – the data it contains. However, if it was managed well, it could provide useful information.

National registries do have the potential to add value to medical research:

  • National registries can be used to force companies and research institutions to make the results of their clinical trials public. This is especially relevant within the European Union. European reporting requirements currently only apply to drug trials and have not yet become legally enforceable. In contrast, the Spanish registry is under national control, and national laws enable regulators to set and enforce transparency rules that go beyond European minimum requirements. (A similar national registry in Germany, PharmNet.Bund, was reportedly set up for exactly that reason.)

  • National registries can provide a comprehensive picture of a country’s research landscape. For example, the European trial registry only lists drug trials, so information on trials of medical devices is scattered across multiple other registries, making it impossible to gain an overview of research activity in that field. Using the Spanish national registry, the report’s authors were able to discover that three quarters of all trial activity in Spain is concentrated in only two regions of the country, and that less than 6% of all trials targeted infectious diseases. This type of data can inform national research policy and funding allocations.

  • Last and certainly not least, national registries can help patients to find trials in their local area that they can enrol in. As patient recruitment is often difficult and expensive, this benefits scientists as well as patients.

The findings from Spain are relevant to clinical trial governance in other countries.

Germany has a similar national registry, PharmNet.Bund. A study currently undergoing peer review shows that PharmNet.Bund also suffers from weak data management by trial sponsors and a lack of effective oversight by German regulators.

Meanwhile, in the UK, there have been discussions about setting up a national trial registry post-Brexit.

The report’s authors, who work for advocacy group Salud por Derecho, examined the records for 5,251 trials conducted in Spain between 2013 and 2019. TranspariMED reviewed an advanced draft and has endorsed the final report, but did not independently re-analyse the data underlying the report.

The report is available online in both Spanish and English language.

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