Re: Non-publication and delayed publication of randomized trials on vaccines: survey
Manzoli et al. found that results of trials on vaccines are often not published for several years after their completion or sometimes not published at all. The authors rightly pointed out the public health risks of non-publication or delayed publication of trial results. Such concerns are also reflected in European Union legislation and the related guidance published by the European Commission [1]. These legal texts will make it mandatory for sponsors to post summary results of clinical trials in the European Clinical Trials Database (EudraCT) from 21 July 2014. The result-related information will become publicly accessible via the EU Clinical Trials Register (EU CTR), as sponsors start to comply with their legal obligations. The register will include results of all trials conducted in the European Economic Area (EEA). Clinical trials conducted outside the EEA will also be included if they form part of a European paediatric investigation plan (PIP) or are otherwise linked to the development of European paediatric medicines [2]. Currently the EU CTR contains protocol information on more than 1000 clinical trials on vaccines (i.e. trials that contain the terms vaccine or vaccination in the title), of which almost 400 include paediatric subjects below 18 years of age. It is expected that the legal obligation for the posting of result-related information will significantly improve timely public dissemination of trial data, including the posting of summary results even before publication in the peer-reviewed literature.
The timelines provided for in the EU Clinical Trials Directive and Commission Guideline do not distinguish between trials concerning vaccines and other interventional trials. Sponsors will now have the obligation to post results for any interventional trials registered in EudraCT within six months following the end of a paediatric clinical trial or twelve months following the end of a trial involving non-paediatric population. For trials that ended in the past sponsors will need to submit the results retrospectively, in accordance with the specific timeframe laid out in a European Commission Guideline 2012/C 302/03 [1]. This will help to increase the publication of unbiased information on safety and efficacy of vaccines and other medicines, in a timely fashion.
Disclaimer:
The views expressed in this letter are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of EMA or one of its committees or working parties.
References:
[1] Commission Guideline - Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. (2012) Official Journal of the European Communities C 302/03.
[2] Egger GF, Herold R, Rodriguez A, Manent N, Sweeney F, Saint Raymond A. European Union Clinical Trials Register: on the way to more transparency of clinical trial data. Expert Rev Clin Pharmacol. 2013 Sep;6(5):457-9.
Manzoli et al. found that results of trials on vaccines are often not published for several years after their completion or sometimes not published at all. The authors rightly pointed out the public health risks of non-publication or delayed publication of trial results. Such concerns are also reflected in European Union legislation and the related guidance published by the European Commission [1]. These legal texts will make it mandatory for sponsors to post summary results of clinical trials in the European Clinical Trials Database (EudraCT) from 21 July 2014. The result-related information will become publicly accessible via the EU Clinical Trials Register (EU CTR), as sponsors start to comply with their legal obligations. The register will include results of all trials conducted in the European Economic Area (EEA). Clinical trials conducted outside the EEA will also be included if they form part of a European paediatric investigation plan (PIP) or are otherwise linked to the development of European paediatric medicines [2]. Currently the EU CTR contains protocol information on more than 1000 clinical trials on vaccines (i.e. trials that contain the terms vaccine or vaccination in the title), of which almost 400 include paediatric subjects below 18 years of age. It is expected that the legal obligation for the posting of result-related information will significantly improve timely public dissemination of trial data, including the posting of summary results even before publication in the peer-reviewed literature.
The timelines provided for in the EU Clinical Trials Directive and Commission Guideline do not distinguish between trials concerning vaccines and other interventional trials. Sponsors will now have the obligation to post results for any interventional trials registered in EudraCT within six months following the end of a paediatric clinical trial or twelve months following the end of a trial involving non-paediatric population. For trials that ended in the past sponsors will need to submit the results retrospectively, in accordance with the specific timeframe laid out in a European Commission Guideline 2012/C 302/03 [1]. This will help to increase the publication of unbiased information on safety and efficacy of vaccines and other medicines, in a timely fashion.
Disclaimer:
The views expressed in this letter are the personal views of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of EMA or one of its committees or working parties.
References:
[1] Commission Guideline - Guidance on posting and publication of result-related information on clinical trials in relation to the implementation of Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. (2012) Official Journal of the European Communities C 302/03.
[2] Egger GF, Herold R, Rodriguez A, Manent N, Sweeney F, Saint Raymond A. European Union Clinical Trials Register: on the way to more transparency of clinical trial data. Expert Rev Clin Pharmacol. 2013 Sep;6(5):457-9.
Competing interests: No competing interests