This article was accepted into the corpus but its outbound wikilinks were never NER-processed — typical at the deepest BFS hop or when the run's entity cap was reached. No expansion funnel to show.
| Brazilian Clinical Trials Registry | |
|---|---|
| Name | Brazilian Clinical Trials Registry |
| Native name | Registro Brasileiro de Ensaios Clínicos |
| Founded | 1997 |
| Location | Brasília, Rio de Janeiro |
| Parent organization | Oswaldo Cruz Foundation |
Brazilian Clinical Trials Registry is Brazil's primary public platform for the registration of clinical trials and interventional studies, established to promote transparency in biomedical research and align Brazilian research practice with international standards. The registry serves researchers, patients, ethics committees, and regulatory agencies by documenting trial protocols, recruitment status, and results summaries. It operates within a network of national and international institutions to support research integrity, reproducibility, and public accountability.
The registry was created in response to evolving international expectations after events such as the Declaration of Helsinki revisions and the emergence of the International Committee of Medical Journal Editors registration policy, with guidance influenced by organizations like the World Health Organization and the Pan American Health Organization. Its founding involved collaboration among Brazilian institutions including the Oswaldo Cruz Foundation, the Ministry of Health (Brazil), and academic centers such as the University of São Paulo and the Federal University of Rio de Janeiro. Over time the registry evolved alongside global initiatives such as the International Clinical Trials Registry Platform and legislation like the Brazilian Clinical Research Law debates, adapting its scope after milestones such as decisions by the Brazilian National Health Surveillance Agency and editorial policies of journals like The Lancet and The New England Journal of Medicine.
Governance relies on a consortium model involving public institutions: the Oswaldo Cruz Foundation manages technical operations, while oversight includes representatives from the Brazilian Ministry of Health, the Brazilian National Research Ethics Commission (CONEP), and academic stakeholders such as the University of Campinas and the State University of Rio de Janeiro. Advisory relationships extend to international partners including the World Health Organization and the European Medicines Agency, and the registry coordinates with regulatory agencies like the Brazilian National Health Surveillance Agency for compliance matters. Steering committees often include members from professional societies such as the Brazilian Society of Clinical Research and funders like the Brazilian National Council for Scientific and Technological Development.
Researchers submit trial entries through an online portal administered by the Oswaldo Cruz Foundation, providing protocol identifiers, sponsor details, and ethics approvals from bodies like CONEP. Typical sponsors include academic centers such as the Federal University of Minas Gerais, public hospitals like the Hospital das Clínicas da FMUSP, and industry sponsors represented by organizations such as the Brazilian Association of Pharmaceutical Companies (BRASÍLIA). The process mirrors international templates established by the International Committee of Medical Journal Editors and the World Health Organization Trial Registration Data Set, requiring milestones that align with regulatory filings to agencies like the Brazilian National Health Surveillance Agency and ethics submissions to institutional review boards at institutions like the Federal University of Rio Grande do Sul.
Registry entries follow structured fields adapted from the World Health Organization Trial Registration Data Set and coding systems like the International Classification of Diseases and the Medical Subject Headings controlled vocabulary. Required content includes protocol summaries, participant eligibility, interventions, and primary and secondary outcomes comparable to datasets used by the European Clinical Trials Database and the United States ClinicalTrials.gov system. Metadata practices coordinate with standards promoted by organizations such as the Global Alliance for Genomics and Health and the International Committee of Medical Journal Editors, while data curation draws on expertise from institutions like the Fiocruz research network.
The registry provides public-facing search and reporting tools used by stakeholders including researchers at the University of Brasília, ethics committees at the Federal University of Pernambuco, patient advocacy groups such as the Brazilian Association of Patients with Rare Diseases, and journal editors at SciELO-indexed publications. Data are leveraged in systematic reviews conducted by groups at the Cochrane Collaboration and health technology assessments by bodies like the Brazilian Network for Health Technology Assessment. Interoperability initiatives link entries to international platforms such as the International Clinical Trials Registry Platform and to bibliographic resources like PubMed for dissemination.
Registry use is reinforced by policies from editorial coalitions like the International Committee of Medical Journal Editors and by oversight from the Brazilian National Health Surveillance Agency and CONEP. Legal debates over mandatory registration have involved stakeholders including the Brazilian Ministry of Health, the Federal Prosecutor's Office (Brazil), and academic legal scholars at the Federal University of Rio de Janeiro Law School. Compliance mechanisms intersect with ethics review workflows at institutions like the University of São Paulo Hospital and with regulatory submissions to the Brazilian National Health Surveillance Agency.
The registry has increased transparency for trials by institutions such as the Butantan Institute and the Fiocruz, and has been cited in policy analyses by the World Health Organization and systematic reviews by the Cochrane Collaboration. Critics from academic centers including the Federal University of Rio Grande do Sul and commentators in outlets such as Folha de S.Paulo have pointed to issues with incomplete data fields, variable update frequency, and challenges integrating with international databases like ClinicalTrials.gov. Reforms advocated by stakeholders including the Brazilian National Council for Scientific and Technological Development and the Ministry of Health (Brazil) emphasize interoperability, mandatory result reporting, and enhanced metadata alignment with bodies such as the World Health Organization and the European Medicines Agency.
Category:Medical registries Category:Research in Brazil