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Where are the Clinical Study Reports we were promised?

The European Medicines Agency has been providing access to Clinical Study Reports far slower than promised, new research shows.

Clinical Study Reports (CSRs) are lengthy documents that contain a vast amount of information and data on clinical trials that cannot be found elsewhere. Pharma companies submit CSRs to regulators to prove that new drugs and vaccines are efficacious and safe.

Years ago, the European Medicines Agency announced that it would proactively make CSRs accessible to independent researchers. It was the first regulator worldwide to do so. Medical researchers strongly applauded the move. (Health Canada has since launched a similar transparency effort.)

However, new research shows that the European Medicines Agency’s efforts have lagged far behind its own disclosure targets.

Instead of releasing CSRs within the target of 60-150 days, the agency usually took more than a year. Less than 2% of CSRs were released on time.

Worse, these are historical data, because the European Medicines Agency suspended the release of CSRs in 2018

The agency first cited staff shortages caused by its relocation from London to Amsterdam. It then argued that the workload caused by the pandemic prevented it from resuming the transparency effort, making an exception only for CSRs for Covid treatments and vaccines.

More than three years later, the agency has still not announced when it will relaunch the initiative.

According to the study authors:

“The clinical data packages released by the EMA according to Policy 0070 contain large amounts of data of relevance for public health but are published with considerable delay relative to the timeline set forth by the EMA, limiting their potential impact on reporting bias. It should be a priority for the EMA to first resume publication of clinical data according to Policy 0070, which remains suspended except for packages relevant to COVID-19, and to reduce the time to publication of all data.”

“The clinical data packages published by the EMA contain large amounts of data of relevance for public health and are an important source of information in research synthesis.”

The authors reviewed 148 clinical data packages containing data on 1,005 clinical trials. They explained that Policy 0070, which governs the release of these documents:

“outlines the EMA's intention to prospectively release clinical data, defined as clinical overviews, clinical summaries, clinical study reports, protocols, protocol amendments, sample case report forms, and documentation of statistical methods and, additionally, individual patient data submitted to the EMA under the centralised marketing authorisation procedure. All clinical data submitted as part of a marketing authorisation application or as part of a post-authorisation procedure for an existing centrally authorised medicinal product falls within the scope of Policy 0070.”


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