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After three years of struggle, scientists fail in bid to access key documents held by European regul

Cochrane scientists have reported that they have been unable to access key documents on eleven clinical trials of vaccines held by the European Medicines Agency (EMA), pointing to a gap between the regulator’s transparency policies and its actual disclosure practices.

The researchers had planned to systematically review all available evidence on the benefits and harms of HPV vaccines, including Clinical Study Reports (CSRs), which provide very detailed information on the design, conduct and outcomes of clinical trials that cannot be found elsewhere.

Pharmaceutical companies are required to submit CSRs to the European Medicines Agency when they apply for a marketing licence for a new drug.

Since 2014, in theory, independent scientists can access these documents by filing a request with the European regulator.

In practice, the Cochrane team reports:

“After three years, we had obtained just 18 Clinical Study Reports (62% of the EMA’s 29 reports)… Unfortunately, the reports still lacked important sections, such as protocols and serious harms narratives… Only three reports included completed case report forms… One study report of 4263 pages was released in 17 files across seven batches over 12 months.”

The scientists discovered that the European regulator itself sometimes does not get to see the full evidence on new drugs and vaccines:

“[EMA correspondence confirmed that] for some studies, the Clinical Study Reports that industry provides to EMA are incomplete (eg, missing appendices).”

Data table source: BMJ 2018

The Cochrane team also found it impossible to obtain the information it needed for its study from pharmaceutical companies, including from companies with strong transparency policies:

“Although GlaxoSmithKline published versions of its Clinical Study Reports on its trial register, the reports often lack serious adverse events narratives and case report forms, and the data on serious adverse events in the reports we downloaded was heavily redacted.”

The scientists warned that their inability to access many CSRs, and the incompleteness and redactions of those CSRs that they were able to obtain, would weaken their ability to accurately assess the benefits and harms of HPV vaccines. They wrote that:

“In our view, independent researchers ought to be able to obtain complete and unredacted Clinical Study Reports within a reasonable time frame without too many constraints or limitations… regulators should release complete and coherent Clinical Study Reports… Urgent changes are essential for open and transparent assessment of the harms and benefits of interventions.”

The European Medicines Agency cited capacity constraints as the reason for its slow release of CSRs. Only twelve EMA staff are assigned to handling the disclosure process, which is time-consuming largely because the regulator redacts information it considers to be commercially confidential before it releases the documents.

This summer, the EMA announced a further slowdown of its proactive CSR disclosure process, citing temporary staff shortages caused by its relocation from London to Amsterdam. At the same time, it permanently narrowed access-on-demand to older CSRs to scientists who are European Union citizens; previously, all scientists worldwide were - in theory - able to gain access to them.

At the time, the EMA's moved caused transparency advocates to warn of "a major threat to open and transparent access to important clinical data".

Note: This blog was written based on research conducted by TranspariMED as part of a grant awarded by HealthWatch UK, an independent British charity. HealthWatch UK did not review this blog prior to publication. The content of this blog is the sole responsibility of TranspariMED, and should not be taken to reflect the position of HealthWatch UK.

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