EMA Seeks to Fine-Tune Official Register

June 1, 2011
Philip Ward

Philip Ward is ACT's European editor, phone +44 1244 538583, philipward1@btconnect.com

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2011, Volume 20, Issue 6

The new online register will help patients access trials information more easily.

The European Medicines Agency (EMA) is planning to expand and develop its new online Clinical Trials Register, which contains information about clinical trials authorized in the European Union and aims to make clinical research more transparent for patients and to avoid unnecessary duplication of trials. The online register can be found at https://www.clinicaltrialsregister.eu.

The main priority now is to improve data quality, particularly the completeness of the questions, their accuracy, and the use of standardized terminology, said Fergus Sweeney, head of the agency's compliance and inspection sector, in a rare interview published in the May edition of Nature Reviews Drug Discovery.

"I want to improve the user experience," he noted. "We need a better search function. This will come partly with having better data quality, but we are also looking at a number of tools that can improve our search function."

Online Register Web Statistics

Within the next 18 months, sponsors should be able to maintain at least some of the data sets directly. Furthermore, users cannot see historical versions of a protocol at present, but that may change in the future, said Sweeney. Also, EMA is considering widening the scope of the system to include trials in earlier development and studies that are conducted wholly overseas, but many of these changes will be driven by legislative requirements.

The new register went live on March 22, 2011. As of May 17, 2011, the number of studies included was 13,066, of which 2,775 involved subjects under 18 years of age. EudraCT has received details of around 2,500 new trials each year, of which a little over a third are Phase I trials. Information about approximately 1,500 trials a year will go into the public domain from now on, Sweeney estimated.

The EMA's register includes trials conducted by both industry and research institutions. The information is made public once the trial has been authorized. It draws its information from the non-public EudraCT database, and encompasses Phase I–IV pediatric trials and Phase II–IV adult trials that have at least one investigator site in Europe and all trials listed in a Pediatric Investigation Plan.

An objective of the new registry is to avoid redundant trials. There was a concern that researchers may repeat procedures in different countries, particularly in pediatric studies, if they are not aware of what others are doing, said Sweeney. In addition, patients, especially those with rare or life-threatening diseases, and their caretakers are more likely to consider joining a clinical trial if they are aware of its existence, so it is beneficial to have a wider overview of research. Transparency is another important issue here.

"Our structure includes the ability to display public contact information, but for older trials this information is not necessarily present yet. We have written to industry associations to ask them to provide contact points for older trials," he commented.

Yet Sweeney does concede that if he were to build a public register from zero, he would do it differently, focusing more directly on the World Health Organization's criteria that must be met for registries to be included in the International Clinical Trials Registry Platform and on a system in which sponsors would post their own information. The EMA is constrained by the historic processes and the data structure, however.

New legislation has also called for a results section to be added to the register, and guidance on this section must be completed, agreed, and published by the European Commission, which is due to happen by the end of 2011. The necessary software will then have to be developed, he concluded.

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