The EU will centralize the registry of clinical trials

During the April 2^nd 2014 session of the European Parliament, a draft law was approved whereby pharmaceutical companies and academic researchers will post the results of clinical trials undertaken in Europe in a publicly – accessible database. This draft law was approved by 594 votes to 17, with 13 abstentions.

According to Glenis Willmott, a member of the Group of the Progressive Alliance of Socialists and Democrats, which is affiliated to the UK Labour Party (S&D, UK), and who steered the draft legislation through the European Parliament “This will make trials more transparent, give hope to patients needing new and better treatments, and boost the number of skilled research jobs here in Europe.”

This measure should also encourage cross-border clinical trials to be carried out, by facilitating cooperation between laboratories and allowing a sufficient number of patients in more than one country to be identified. In this way, the trials will become more comprehensive and dependable and also encourage research into the development of new drugs for the treatment of rare diseases. These trials will be beneficial in allowing patients suffering from these diseases in more than one country to be brought together.

This legislation will streamline the rules governing clinical trials across Europe, and will empower the European Commission to act as the regulatory agency. Detailed summaries of the clinical trials and final reports for each trial must be made available in a publicly-accessible EU database still to be developed.

The registry of clinical trials

Participants in the Ministerial Summit on Health Research¹, which took place in November 2004 in Mexico City, agreed to seek the support of the World Health Organization (WHO) in bringing about the creation of “an international network of clinical trials registers to ensure a single point of access and the unambiguous identification of trials”. This initiative was expanded upon during the 58^th World Assembly by means of resolution WHA58.34², which called upon the world wide scientific community, international partners, the private sector, society in general and other interested parties “ to establish a voluntary platform to link clinical trials registers in order to ensure a single point of access and the unambiguous identification of trials with a view to enhancing access to information by patients, families, patient groups and others”.

Shortly after the publication of the WHO resolution on 1 July 2005, the International Committee of Medical Journal Editors (ICMJE), with support of the World Association of Medical Editors (WAME), declared that no trial would be considered for publication if it were not included in a registry of clinical trials. This had the support of the pharmaceutical industry which itself had pledged to make data from clinical trials more transparent and accessible. Then in October 2008 the Declaration of Helsinki was updated by the World Medical Association, and the updated text states that “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.”

Carrying on from these initiatives, the development of databases for registering clinical trials was begun in various countries, the majority of them taking as their model the WHO international platform. The ClinicalTrials.gov site, managed by the US National Library of Medicine (NLM), was the first online platform and is today the largest and most utilized example of this.

Following this global trend, officials from 26 nations participating in the 11th World Congress in Public Health and the 8th National Congress of Public Health³, which took place in Rio de Janeiro in August 2006, signed the Declaration of Rio⁴ in which, amongst other resolutions, they committed to fulfilling the Millennium Development Goals and to “make research results publicly available and incorporate them into the formulation of public policies and health interventions” (free translation). As a result, at the beginning of May 2007, the “Recommendation” was published that journals in SciELO and LILACS that involve clinical trials should be registered in open access databases.

Thus commenced the development of the Brazilian Registry of Clinical Trials (Rebec), created through a joint project between the Ministry of Health of Brazil, the Oswaldo Cruz Foundation, the National Health Surveillance Agency (ANVISA), and BIREME / PAHO / WHO. Rebec was launched in December 2010 and accredited in April 2011 by WHO through the International Clinical Trials Registry Platform (ICTRP)⁶. Thus, primary registries created by Rebec are automatically added to the WHO network. Brazil, via Rebec, is integrated into the group of 17 systems⁷ from other countries that make up the ICTRP network.

Notes

¹ Ministerial Summit on Health Research – http://www.who.int/entity/rpc/summit

² WHA58.34 – http://www.wpro.who.int/health_research/policy_documents/ ministerial_summit_on_health_research_may2005.pdf

³ 11th World Congress in Public Health and the 8th National Congress of Public Health – www.abrasco.org.br/grupos/arquivos/20091025204818.pdf

⁴ Declaration of Rio – http://espacio.bvsalud.org/files/3/0/081331232006/declaracao_rio.pdf

⁵ Recommendation – http://espacio.bvsalud.org/files/5/1/051111052007/recomend_edit_rev_2007%20port.pdf

⁶ ICTRP – http://www.who.int/ictrp/en/

⁷ group of 17 systems – http://www.who.int/ictrp/network/primary/en/

References

Clinical trials: clearer rules, better protection for patients. European Parlament / news. 02 April 2014. Available from: http://www.europarl.europa.eu/news/en/news-room/content/20140331IPR41186/html/Clinical-trials-clearer-rules-better-protection-for-patients

Wikipedia. ClinicalTrials.gov. Available from: http://en.wikipedia.org/wiki/ClinicalTrials.gov

Wikipedia. International Committee of Medical Journal Editors. In Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Available from: http://en.wikipedia.org/wiki/Uniform_Requirements_for_Manuscripts_Submitted_to_ Biomedical_Journals#International_Committee_of_Medical_Journal_Editors

WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. WMA. 2008. Available from: http://www.wma.net/en/30publications/10policies/b3/

Links externos

WHO international platform – http://apps.who.int/trialsearch/

ICMJE – http://www.icmje.org/

ClinicalTrials.gov – http://clinicaltrials.gov/

LILACS – http://lilacs.bvsalud.org/

Rebec – http://ensaiosclinicos.gov.br/

About Lilian Nassi-Calò

Lilian Nassi-Calò studied chemistry at Instituto de Química – USP, holds a doctorate in Biochemistry by the same institution and a post-doctorate as an Alexander von Humboldt fellow in Wuerzburg, Germany. After her studies, she was a professor and researcher at IQ-USP. She also worked as an industrial chemist and presently she is Coordinator of Scientific Communication at BIREME/PAHO/WHO and a collaborator of SciELO.

Translated from the original in Portuguese by Nicholas Cop Consulting.