{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2024,3,13]],"date-time":"2024-03-13T08:58:00Z","timestamp":1710320280731},"reference-count":39,"publisher":"FapUNIFESP (SciELO)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cad. Sa\u00fade P\u00fablica"],"published-print":{"date-parts":[[2017]]},"abstract":"<jats:p>Resumo: Este estudo visou a caracterizar os ensaios cl\u00ednicos com medicamentos envolvendo crian\u00e7as e adolescentes brasileiros, registrados nas bases de dados do Clinical Trials e da Registro Brasileiro de Ensaios Cl\u00ednicos (ReBEC), entre os anos de 1994 e 2014. Apenas 462 ensaios cl\u00ednicos envolveram brasileiros nessa faixa et\u00e1ria. A partir de 2003, houve aumento no n\u00famero de registros, com expressiva queda em 2011. Dentre esses, 35,5% foram sediados no Brasil. Os ensaios cl\u00ednicos internacionais foram majoritariamente conduzidos por empresas norte-americanas. Em ambos os casos, a ind\u00fastria multinacional foi a principal fonte de apoio financeiro. Predominaram ensaios cl\u00ednicos de fase III com antivirais em formas farmac\u00eauticas injet\u00e1veis e s\u00f3lidas orais. Os ensaios cl\u00ednicos nacionais apresentaram maior varia\u00e7\u00e3o quanto \u00e0s formas farmac\u00eauticas e maior porcentual de formula\u00e7\u00f5es l\u00edquidas investigadas, em compara\u00e7\u00e3o aos internacionais. Al\u00e9m da forte depend\u00eancia externa para a realiza\u00e7\u00e3o dos ensaios cl\u00ednicos, destacou-se o desafio para o cuidado pedi\u00e1trico no Brasil, que apresenta peculiaridades epidemiol\u00f3gicas em um ambiente prop\u00edcio ao uso de medicamentos n\u00e3o licenciados para crian\u00e7as.<\/jats:p>","DOI":"10.1590\/0102-311x00169515","type":"journal-article","created":{"date-parts":[[2017,6,14]],"date-time":"2017-06-14T23:39:34Z","timestamp":1497483574000},"source":"Crossref","is-referenced-by-count":3,"title":["Perfil dos ensaios cl\u00ednicos envolvendo crian\u00e7as brasileiras"],"prefix":"10.1590","volume":"33","author":[{"given":"Jean Mendes de Lucena","family":"Vieira","sequence":"first","affiliation":[{"name":"Universidade Federal do Rio de Janeiro,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elisangela da Costa","family":"Lima","sequence":"additional","affiliation":[{"name":"Universidade Federal do Rio de Janeiro,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcelo Gerardin Poirot","family":"Land","sequence":"additional","affiliation":[{"name":"Universidade Federal do Rio de Janeiro,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miriam","family":"Ventura","sequence":"additional","affiliation":[{"name":"Universidade Federal do Rio de Janeiro,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helena Lutescia Luna","family":"Coelho","sequence":"additional","affiliation":[{"name":"Universidade Federal do Cear\u00e1,  Brazil"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"530","reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"171","DOI":"10.1016\/j.jped.2013.03.004","article-title":"A critical comparison between the World Health Organization list of essential medicines for children and the Brazil list of essential medicines (Rename)","volume":"89","author":"Coelho HLL","year":"2013","journal-title":"J Pediatr (Rio J.)"},{"issue":"3","key":"ref2","doi-asserted-by":"crossref","first-page":"S131","DOI":"10.1097\/01.CCM.0000054905.39382.58","article-title":"Research in children","volume":"31","author":"Burns JP","year":"2003","journal-title":"Crit Care Med"},{"key":"ref3","doi-asserted-by":"crossref","first-page":"57","DOI":"10.1590\/S1984-82502009000100007","article-title":"Prescri\u00e7\u00e3o e preparo de medicamentos sem formula\u00e7\u00e3o adequada para crian\u00e7as um estudo de base hospitalar","volume":"45","author":"Costa PQ","year":"2009","journal-title":"Braz J Pharm Sci"},{"key":"ref4","series-title":"Formul\u00e1rio terap\u00eautico nacional 2008: RENAME 2006","first-page":"18","volume-title":"F\u00e1rmacos em crian\u00e7as","author":"Liberato E","year":"2008"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"53","DOI":"10.3390\/pharmaceutics3010053","article-title":"Factors and mechanisms for pharmacokinetic diferences between pediatric population and adults","volume":"3","author":"Fernandez E","year":"2011","journal-title":"Pharmaceutics"},{"key":"ref6","series-title":"Boas pr\u00e1ticas cl\u00ednicas: documentos das Am\u00e9ricas"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"803","DOI":"10.1016\/S0140-6736(04)16942-0","article-title":"Clinical trials in children","volume":"364","author":"Cadwell PH","year":"2004","journal-title":"Lancet"},{"key":"ref8","first-page":"465","article-title":"Uso de medicamentos off-label e n\u00e3o licenciados em unidade de tratamento intensivo neonatal e sua associa\u00e7\u00e3o com escores de gravidade","volume":"88","author":"Carvalho CG","year":"2012","journal-title":"J Pediatr (Rio J.)"},{"key":"ref9","series-title":"5-year Report to the European Commission. 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