Adherence to clinical trial registration in countries of Latin America and the Caribbean, 2015/Cumplimiento del registro de ensayos clinicos en los paises de América Latina y el Caribe, 2015/Adesao ao registro de ensaios clinicos em paises da America Latina e Caribe, 2015

Objective. To determine the prevalence of clinical trial registration in the International Clinical Trial Registry Platform (ICTRP) for studies from Latin America and the Caribbean (LAC) and to identify the key characteristics that lead to prospective and retrospective registration. Methods. A cross-sectional study identified published, clinical trial studies through a search of PubMed, LILACS (Latin American and Caribbean Center on Health Sciences Information), and the Cochrane Central Register of Controlled Trials. Studies were included if published on 1 January-31 December 2015, at least one author was affiliated with at least one LAC country, the clinical trial was conducted in at least one LAC site, and the full text of the article was available. A manual search of reference lists was also conducted. ICTRP registration information and key trial characteristics were compared. Results. Of 1 502 CT references that met inclusion criteria, 297 were randomly-selected, 90.9% of which were published in English, 65% from Brazil, and 76.8% had a LAC author as the first author. The proportion of CT registered in the ICTRP was 59.9 %, of which 51.7% were registered prospectively. Clinicaltrials.gov was most frequently used registry (84.8%), followed by the Registro Brasileiro de Ensaios Clinicos and the Registro Publico Cubano de Ensayos Clinicos. Key characteristics that favored registration were being in study phase 3 or 4 or being a multi-center study. Data was compared to a similar study from 2013 that reported a registration rate of only 19.8%. Conclusions. Registration adherence and prospective registration have increased in LAC in recent years, but the proportion of unregistered CT remains high. While there are still many challenges to overcome, the adherence strategies implemented in recent years have proven effective. Keywords Clinical trial as topic; registries; LILACS; MEDLINE; Latin America; Caribbean region. Objetivo. Determinar la prevalencia del registro de ensayos clinicos de America Latina y el Caribe en la Plataforma de Registros Internacionales de Ensayos Clinicos (ICTRP, por su sigla en ingles) y definir los elementos clave que fomentan el registro prospectivo y retrospectivo de estudios. Metodos. Se realizo un estudio transversal para encontrar los ensayos clinicos publicados mediante una busqueda en PubMed, LILACS (Centro Latinoamericano y del Caribe para Informacion en Ciencias de la Salud) y el Registro Central Cochrane de Ensayos Clinicos