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Health groups sound alarm over EMA plan to hide clinical trial protocols

A European Medicines Agency plan to hide clinical trial protocols for up to five years after trial completion “is unacceptable and is not in the best interests of science, patients, or of furthering medical innovation,” eleven health groups warn today.

An EMA consultation document released early this year revealed plans to allow pharma companies to defer publication of the underlying trial protocols for Phase II and Phase III clinical trials for up to 5 years after trial end. In contrast, companies have to make the summary results of such trial public on the European trial registry within just one year. CTIS

The letter warns that:

“If EMA persists with this approach, medical researchers, systematic reviewers, and public health bodies worldwide will find themselves in a profoundly absurd situation. They will be able to rapidly access a summary of the outcomes of European drug trials, but will not be able to discover precisely how those outcomes were generated.”

“This is not a trivial issue. Researchers need access to detailed information on trial design, including measures taken to minimise bias, statistical methods, and dosage regimes in order to fully interpret trial outcomes.”

“[The EU Clinical Trial] Regulation contains no provision which could be used as basis for delaying the publication of protocols."

"To the contrary, it clearly states that ‘[t]he information in the EU database should be public, unless specific reasons require that a piece of information should not be published.’”

The letter urges the EMA Management Board “to direct the agency to disclose unredacted clinical trial protocols for Phase II and Phase III trials on CTIS at the time that the summary results of the related trials are made public on CTIS.”

Tilly Metz, Member of the European Parliament, said:

"Transparency of clinical trial protocols is key to foster research in Europe. This delay is harmful!, I am calling on EMA to review its decision."

Eleven health groups including TranspariMED signed up to the letter, which can be accessed here:

Open letter to EMA on clinical trial protocols 20221017
Download PDF • 294KB

Till Bruckner, founder of TranspariMED, said:

“In recent years, the European Medicines Agency has worked hard to improve clinical trial reporting, and has succeeded in getting an unprecedented amount of trial outcomes made public. Against that positive backdrop, the idea of hiding the underlying research protocols is simply bizarre."

"We hope that the agency will reconsider this misstep, and release trial protocols in line with the letter and spirit of the Clinical Trial Regulation.”

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