E-DRUG: HAI Europe Policy Paper; Call for clinical trial data transparency
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** Just published: HAI EUROPE POLICY PAPER; paper "Protecting citizens' health: transparency of clinical trial data on medicines in the EU" **
In the context of the on-going negotiations on the Clinical Trials Regulation and the European Medicines Agency's (EMA's) work towards the proactive publication of clinical trial data, HAI Europe has published a policy paper "Protecting citizens' health: transparency of clinical trial data on medicines in the EU",<http://bit.ly/1a9Xrga> with the objective of shaping the debate towards greater data transparency. We would like to share this Policy Paper with all involved stakeholders.
Many adverse drug reactions, including deaths, could have been avoided, had the public known about the undisclosed effects of medicines. In addition, open access to trial data can facilitate independent re-analyses of medicines' claimed efficacy and comparison between therapies. The transparency of clinical trial data also responds to an ethical obligation. According to the Declaration of Helsinki, authors have the duty to make publicly available the results of their studies: whether positive, negative or inconclusive.
Unfounded concerns over commercial confidentiality have for too long prevented public access to full clinical trial data. However, in a previous assessment the European Ombudsman found that the disclosure of clinical study reports and trial protocols does not jeopardise commercial interests. Above all, human health is an overriding public interest. Moreover, open access to trial data can safeguard patients' confidentiality.
The consolidation of recent advances on data transparency and the achievement of public access to full sets of trial data depend on the outcomes of on-going policy and legal developments. HAI Europe's policy paper argues that increased public knowledge on the effects of medicines plays an unquestionable role in the strengthening and protection of public health.
For more information on HAI Europe's position on clinical trial data transparency, please find attached our policy paper, which you can also access by copying this link: http://bit.ly/1a9Xrga
Please feel free to distribute the paper as appropriate and do not hesitate to get in touch with us, for any discussion on this topic. Contact HAI Europe Policy Advisor: Ancel.la@haieurope.org<mailto:Ancel.la@haieurope.org>
Kind regards,
Leah Cowan
Leah Cowan
Communications Officer
Health Action International (HAI) Europe
Overtoom 60(II)
1054 HK Amsterdam
The Netherlands
Tel: +31 20 683 3684
Email: leah@haieurope.org