HAI Europe Policy Paper on Clinical Trial Data Transparency
In the context of the current negotiations on the Clinical Trials Regulation and the EMA’s work towards the proactive publication of trial data, HAI Europe has published a policy paper “Protecting citizens’ health: transparency of clinical trial data on medicines in the EU”, with the objective to shape the debate towards greater data transparency.
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.
Read Policy Paper here
Winners of the Prescrire Awards 2013
On Thursday 3rd October, HAI Member, Barbara Mintzes proudly received the award for the French edition of our collaborative WHO/HAI manual ‘Understanding and Responding to Pharmaceutical Promotion. A Practical Guide' (ed Mintzes, B.). It caught the attention of judges for its applicable and educational content in helping physicians, pharmacists and students to consider and manage promotional influence from pharmaceutical companies.
Originally published in English in 2009, it was translated into French this year ("Comprendre la promotion pharmaceutique et y répondre. Un manuel pratique", translated by Haute Autorité de Santé), and is written by doctors, pharmacists and academics working for quality care in response to the lack of training on the subject.
Prescrire’s review summarises: “Each chapter is easy to read, well structured, illustrated with concrete examples and practical proposals for health professionals. Boxes highlight important questions to ask. The argument is well-referenced, in particular from the work of independent teams of pharmaceutical companies.”
The manual is available to download for FREE on the HAI Global website in four languages: English, French, Spanish and Russian; www.haiweb.org