Made available in DSpace on 2014-06-11T19:27:57Z (GMT). No. of bitstreams: 0 Previous issue date: 2001Bitstream added on 2014-06-13T18:56:50Z : No. of bitstreams: 1 mantovanineto_f_me_botfm.pdf: 1481420 bytes, checksum: 1b888bb63cac554aeea6a214944c0cf2 (MD5) / Pesquisas envolvendo seres humanos têm sido realizadas há muito tempo. Com o passar dos anos, regulamentações foram sendo instituídas com o objetivo de proteger os direitos e integridade dos participantes e de assegurar que os dados e resultados dos estudos fossem dignos de credibilidade. Hoje, além de regulamentações locais, os estudos clínicos devem ser conduzidos de acordo com normas internacionais (Good Clinical Practice - GCP) de pesquisa clínica. Neste trabalho, tentamos avaliar, através de questionários, o crescimento da pesquisa clínica no Brasil, nos últimos cinco anos. Fizemos contato com 61 indústrias farmacêuticas situadas na cidade de São Paulo e 200 investigadores brasileiros, envolvidos em estudos clínicos. 44% das indústrias comprometeram-se a responder um questionário. Desses 44%, obtivemos retorno de 59% delas. A taxa de resposta por parte dos investigadores foi de 23%. Comparações de dados em dois períodos distintos (há cinco anos e atualmente) demonstraram aumento, estatisticamente significativo, de número de pessoas nos departamentos de pesquisa, número de protocolos, número de pacientes envolvidos em estudos clínicos, número de centros habilitados e estados onde as pesquisas são conduzidas. Houve ainda, diminuição de protocolos fase IV, aumento de protocolos fase II e III, e mais investimentos financeiros por parte das indústrias farmacêuticas. Através de respostas abertas e subjetivas, concluímos que, além do crescimento quantitativo, houve crescimento qualitativo da pesquisa clínica no Brasil. Hoje, o país é considerado emergente e com grande potencial para desenvolvimento de novos produtos... / Clinical research has been conducted for a long time. Along the years, resolutions have been implemented to assure that the rights and integrity of trial subjects are protected, and that the data and reported results are credible. Nowadays, besides local resolutions, clinical trials must be conducted according to international guidelines (Good Clinical Practices – GCP). In this study we tried to evaluate, through questionnaires, the growth of clinical research in Brazil in the last five years. Sixty-one pharmaceutical industries located in São Paulo city and 200 Brazilian investigators involved with clinical trials were contacted. Forty-four percent of the industries committed to answer a questionnaire. Results were obtained from 59% of them. The rate of response from the investigators was 23%. Comparing data from two different points in time (five years ago and nowadays) there was significant difference in the number of members working in clinical research departments, number of protocols, number of trial patients, number of qualified sites, and number of states where the trials have been conducted. It was also observed a decrease in phase IV trials, increase of phase II and III trials, and more financial investments from industries in this area. Opened and spontaneous responses allowed us to conclude that clinical research in Brazil has not only increased, but has also improved its quality. Today, Brazil is considered to be an emergent country and presents with high potential to develop new products. Although clinical research has grown, one of the biggest concerns to conduct clinical trials in the country is the lack of trained and qualified human resources to... (Complete abstract, click electronic access below)

Orientador: Marcelo Fabiano de Franco / Resumo: Pesquisas envolvendo seres humanos têm sido realizadas há muito tempo. Com o passar dos anos, regulamentações foram sendo instituídas com o objetivo de proteger os direitos e integridade dos participantes e de assegurar que os dados e resultados dos estudos fossem dignos de credibilidade. Hoje, além de regulamentações locais, os estudos clínicos devem ser conduzidos de acordo com normas internacionais (Good Clinical Practice - GCP) de pesquisa clínica. Neste trabalho, tentamos avaliar, através de questionários, o crescimento da pesquisa clínica no Brasil, nos últimos cinco anos. Fizemos contato com 61 indústrias farmacêuticas situadas na cidade de São Paulo e 200 investigadores brasileiros, envolvidos em estudos clínicos. 44% das indústrias comprometeram-se a responder um questionário. Desses 44%, obtivemos retorno de 59% delas. A taxa de resposta por parte dos investigadores foi de 23%. Comparações de dados em dois períodos distintos (há cinco anos e atualmente) demonstraram aumento, estatisticamente significativo, de número de pessoas nos departamentos de pesquisa, número de protocolos, número de pacientes envolvidos em estudos clínicos, número de centros habilitados e estados onde as pesquisas são conduzidas. Houve ainda, diminuição de protocolos fase IV, aumento de protocolos fase II e III, e mais investimentos financeiros por parte das indústrias farmacêuticas. Através de respostas abertas e subjetivas, concluímos que, além do crescimento quantitativo, houve crescimento qualitativo da pesquisa clínica no Brasil. Hoje, o país é considerado emergente e com grande potencial para desenvolvimento de novos produtos... (Resumo completo, clicar acesso eletrônico abaixo) / Abstract: Clinical research has been conducted for a long time. Along the years, resolutions have been implemented to assure that the rights and integrity of trial subjects are protected, and that the data and reported results are credible. Nowadays, besides local resolutions, clinical trials must be conducted according to international guidelines (Good Clinical Practices - GCP). In this study we tried to evaluate, through questionnaires, the growth of clinical research in Brazil in the last five years. Sixty-one pharmaceutical industries located in São Paulo city and 200 Brazilian investigators involved with clinical trials were contacted. Forty-four percent of the industries committed to answer a questionnaire. Results were obtained from 59% of them. The rate of response from the investigators was 23%. Comparing data from two different points in time (five years ago and nowadays) there was significant difference in the number of members working in clinical research departments, number of protocols, number of trial patients, number of qualified sites, and number of states where the trials have been conducted. It was also observed a decrease in phase IV trials, increase of phase II and III trials, and more financial investments from industries in this area. Opened and spontaneous responses allowed us to conclude that clinical research in Brazil has not only increased, but has also improved its quality. Today, Brazil is considered to be an emergent country and presents with high potential to develop new products. Although clinical research has grown, one of the biggest concerns to conduct clinical trials in the country is the lack of trained and qualified human resources to... (Complete abstract, click electronic access below) / Mestre