Non-fulfilment all over the European Union (EU), including Italy, of due transparency regarding the registration in publicly available databases of research clinical trials and their results runs contrary to the human right to equitable access to health and puts financial resources for research at risk. This article, authored by AIFA (Italian Medicines Agency) Director General Dr. Luca Li Bassi, adds to debate while highlighting the relevant steps forward recently taken by Italy
By Dr. Luca Li Bassi
AIFA (Agenzia Italiana del Farmaco – Italian Medicines Agency)
Italy’s Way Forward in Clinical Trials Transparency
The availability and full access to transparent information on clinical trials contributes to the protection of public health as well as to the promotion of innovation and clinical research advances. This fundamental principle is at the basis of the increasing commitment from all the concerned institutions at the EU level to stimulate the publication of the results of the clinical trials on the international registries. In fact, some studies indicate low percentages of publication rates of trials results, especially of those non-commercial (related to academic and independent non-profit research). According to a recent elaboration by the European Medicines Agency (EMA), the rate of publication in the European register EudraCT of nonprofit trials results was found to be less than 25%, while the publication of the results of the sponsors’ trials on the same register appears to be around 75%. The National Agencies – and among them AIFA – in strong cooperation with the EMA and the European Commission follow this aspect with particular attention, in order to increase the percentage of publication of the results of the trials. To this end, the principles and indications for the publication of results of pediatric trials and trials in the adult population have just been published by the EU Commission on EudraLex, Vol. 10, Clinical Trials, with a reminder to all sponsors, profit and nonprofit, to apply these requirements and proceed with the publication within the established terms.
Furthermore, Regulation (EU) No. 536/2014 of future implementation on clinical trials of medicines for human use imposes transparency in the conduct of studies, from their authorization to the publication of the results on the EU Portal, including negative results.
To this regard, the European Commission, EMA and the Network of the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of the obligation to submit a summary of the results in the EU database.
Transparency as main driver to equal access to treatments is also the value underneath the commitment of the Italian Ministry of Health which in February 2019 submitted to the WHO a draft resolution for the implementation of measures to enhance transparency of markets for drugs, vaccines and health technologies. In the document it is also mentioned the lack of direct and simple access to complete information on the results of clinical trials and post-marketing studies. The Resolution – adopted in May 2019 from 192 out of 194 countries gathered in the 72nd World Assembly of the WHO – invites Member States to take the necessary measures to support the dissemination and access to data of clinical trial results regardless of their outcomes, including costs, where already public. Italy was the first country to submit a recommendation on transparency to a supranational body such as WHO, aiming to guarantee that health investments are committed as efficiently as possible, so to give the maximum return in terms of global health impact.
The more transparent the system is, the wider access to health is provided. The goal is set, the roadmap clear. Cooperation and strong commitment of the entities involved is the key to proceed.
EMA: Call for all sponsors to publish clinical trial results in EU database https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database
EudraLex – Volume 10 – Clinical trials guidelines https://ec.europa.eu/health/documents/eudralex/vol-10_en#fragment1
Clinical trials – Regulation EU No 536/2014 https://ec.europa.eu/health/human-use/clinical-trials/regulation_it
Letter to stakeholders regarding the requirements to provide results for authorised clinical trials in EUDRACT https://www.ema.europa.eu/en/documents/other/joint-letter-european-commission-ema-hma-stakeholders-regarding-requirements-provide-results_en.pdf
Italy’s Draft WHO resolution: Improving the transparency of markets for drugs, vaccines and other health-related technologies https://www.keionline.org/29721
Resolution adopted by the 72nd WHO Word Assembly ‘Improving the transparency of markets for medicines, vaccines, and other health products’ http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_ACONF2Rev1-en.pdf
On the same topic recently on PEAH
‘The Evil of Unregistered Clinical Trials in Europe‘ by Daniele Dionisio