Editorial Note: Leah Cowan and Ancel-la Santos from Health Action International wrote this post covering the release of a HAI position paper on Access to Clinical Trial Data. HAI have been to the forefront of the move to patient reporting of Adverse Events. It has a position as a partner with the European Consumer Organization (BEUC) in support of EMA in the current legal action triggered by AbbVie.
Health action international – HAI
In light 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 further shape the debate towards greater data transparency.
Clinical trial data must be made publicly available for three main reasons:
- Firstly, to strengthen the protection of public health; many adverse drug reactions (ADRs), including deaths, could have been avoided, had the public known about the undisclosed effects of the medicines that caused them harm. In addition, open access to trial data can facilitate independent re-analyses of medicines’ claimed efficacy and comparison between therapies.
- Secondly, disclosure of CT data will enhance the cost-effectiveness of public health expenditure, by ensuring that resources are allocated to medicines which have an assured safety and efficacy profile.
- Lastly, CT data should be made available for ethical reasons. If trial data is not publicly available, it would be an affront to the large number of participants that are exposed to safety risks when participating in a trial. According to the Declaration of Helsinki, authors have the duty to publish the results of their studies – whether positive, negative or inconclusive.
For too long, unfounded concerns over commercial confidentiality have 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. In addition, according to the Treaty on the Functioning of the EU, human health is an overriding public interest. Whilst it is suggested that open access to trial data could endanger patients’ confidentiality, in order to allow for accurate re-analysis by independent researchers, de-identification methods can be applied in ways that patient confidentiality is upheld whilst the robustness of the data maintained.
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.
You can access the Policy Paper for free.