title: Regulatory transparency: social, technical, and ethical aspects of clinical trial data access.
abstract: In the field of health regulation, enabling public access to data from clinical trials is a process currently undergoing consolidation by the principal regulators worldwide. This paper discusses recent developments in public policy regarding regulatory transparency, and the risks and benefits of a regulatory impact-analysis on clinical trial reports, from the perspective of the key stakeholders (i.e., patients, prescribers, government, society, industry, and regulators). Additionally, the social, technical, and ethical aspects of the datasharing process are highlighted, including access limits, commercially-confidential data and patent rights, privacy of research subjects, arrangements and publicity tools, and clinical trials registration. Furthermore, perspectives on improvement and expansion of regulatory transparency policies are presented, contextualizing North American, Latin American, and European experiences, and highlighting in-teragency cooperation and collaboration initiatives that aim to harmonize health programs and regulatory convergence.
authors.affiliation: Medicine Office, Brazilian Health Surveillance Agency, Brasília, Brazil, varley.sousa@anvisa.gov.br.
authors.forename: Varley Dias
authors.initials: VD
authors.lastname: Sousa
authors.affiliation: Health Sciences Department, University of Brasilia, Brasília, Brazil.
authors.forename: Dâmaris
authors.initials: D
authors.lastname: Silveira
mesh_terms: D022126:Access to Information / Q000941:ethics / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D003219:Confidentiality; D030881:Disclosure / Q000941:ethics / Q000331:legislation & jurisprudence*; D004345:Drug Industry; D005060:Europe; D006076:Government; D006801:Humans; D007843:Latin America; D009656:North America; D011640:Public Policy; D012941:Social Responsibility; D014481:United States; D014486:United States Food and Drug Administration