EMA calls for 'stakeholder' input on design of new clinical trials database

By Gareth Macdonald

- Last updated on GMT

EMA quizzes 'stakeholders' about design of new clinical trials database
EMA quizzes 'stakeholders' about design of new clinical trials database

Related tags Pharmaceutical industry Food and drug administration

The EMA has called for input on the design of the public clinical trial database it is developing via a survey sent to "stakeholders."

Since 2010, the European Medicines Agency's (EMA) approach to the release of trial data has been governed by policy 0043​, which allows it to share requested information but also permits the redaction of data considered ‘commercially confidential.’

In parallel, clinical trial sponsors have also been required to enter results summaries in the publicly available EudraCT database.

All this will change next year under regulations​ adopted in April 2014, which streamline trial submission procedures and force drugmakers to publish what MEP Glenis Willmott, rapporteur for the Clinical Trials Regulation, called the results of “unflattering” studies​.

Around half of all trials are never published, usually those with negative or disappointing results. It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective, or even dangerous​.”


The EMA was tasked with developing an online portal to which sponsors must upload data and setting up a public database of trial results by next January.

In October last year, the Agency set out its general approach to the publication of trial data​.

Last night the EMA called for input on the design of the public database via a survey sent to people registered in its stakeholder database.

The EMA told us: “We are sending you this survey to consult you, as potential user of the website, and find out how to design the search details and to ask what you think of the information that will be published on the clinical reports​.”

"It is a standard process for the EMA to consult its stakeholders when designing a new database or website. This practical approach is meant to have feedback from potential users in order to build an interface taking into account their various needs and expectations.

"As such, the purpose of this survey is to ascertain views and preferences on format and search aspects of the website for the publication of clinical reports, thus helping us design a more appropriate website responding to users’ needs.

"For this survey, the Agency has sampled as wide a range of stakeholders as possible to be in a position to take into account the needs of all potential users​" the EMA said, adding "given the technical nature of this survey, the Agency is currently not planning to publish its results but will take them into consideration when developing the website​." 

Previous iterations of the database policy drew criticism ​from transparency campaigners, particularly a plan to prevent users from downloading or saving information that was later abandoned​.

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