European bodies launch further push for publication of clinical trial results

The European Medicines Agency has called for improved publication rates for clinical trials, with 5,855 of a possible 18,432 as yet failing to adequately report results. 

The European Medicines Agency (EMA) has also reported that in only 68.2% of completed trials, were sponsors in compliance with the publication requirements listed in the EudraCT database, and has called for increased transparency.

The calls follow an investigation published in the British Medical Journal (BMJ) last year, and echo comments from the UK’s Science and Technology Select Committee in January.

A letter has been prepared by the European Commission, EMA and the Heads of Medicines Agencies to alert sponsors of clinical trials to the low rates of reporting, and to remind them of their obligations. Sponsors, be they academic or industrial, are the responsible parties for recording data on the system.

The letter states:

“Underreporting in general and selective reporting of trials with positive outcome may lead to potentially avoidable redundancies in the conduct of clinical trials and compromise the economic and scientific efficiency of clinical research. In addition, unreported clinical trials with unfavourable outcome can have negative public health implications. Academic and other non-commercial sponsors are particularly encouraged to post the results of their trials in EudraCT in order to maximise their valuable contribution to meet public health needs and to advance clinical research especially where commercial interest is weaker.”

The particular focus on academic and non-commercial sponsors echoes the findings of the BMJ report which found that trial reporting was comparatively good within the pharmaceutical industry, but poorer within academic settings and organisations not conducting large numbers of trials.

Read the EMA’s press release here, and the letter to sponsors here.

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Published on 5. July 2019 in News, News EU