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文章基本信息

  • 标题:AIDS, ativismo e regulação de ensaios clínicos no Brasil: o Protocolo 028
  • 其他标题:AIDS, activism, and the regulation of clinical trials in Brazil: Protocol 028
  • 本地全文:下载
  • 作者:Oliveira, Maria Auxiliadora ; Santos, Elizabeth Moreira dos ; Mello, José Manoel Carvalho
  • 期刊名称:Cadernos de Saúde Pública
  • 印刷版ISSN:0102-311X
  • 电子版ISSN:1678-4464
  • 出版年度:2001
  • 卷号:17
  • 期号:4
  • 页码:863-875
  • DOI:10.1590/S0102-311X2001000400020
  • 语种:Portuguese
  • 出版社:Escola Nacional de Saúde Pública,Fundação Oswaldo Cruz
  • 摘要:

    This paper examines the politics and practices of drug evaluation in Brazil. It traces the history of AIDS activists' influence on the organization of modern clinical trials and their scientific rationale. Using the Merck indinavir trial as a case study, the authors discuss how organized civil society has developed strategies to intervene in the course of drug evaluation trials, shaping them according to its own interests. Adopting translation sociology as the theoretical framework, the paper describes and analyzes the strategies used by activists from "Grupo PelaVidda/SP" (an AIDS NGO) to build a consensus concerning indinavir monotherapy's lack of efficacy. The study considers the several regulatory forums involved in dealing with the controversy during the trial period.

  • 关键词:Síndrome de Imunodeficiência Adquirida;Ética;Ensaios Clínicos
  • 其他关键词:Acquired Immunodeficiency Syndrome;Ethics;Clinical Trials
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