Canadian Institutes of Health Research, Ottawa, Ontario, Canada.
Rev Panam Salud Publica. 2011 Jul;30(1):87-96.
The objective of this article is to propose a roadmap toward transparency of clinical trials in the Americas by their prospective registration and results disclosure. This will broaden access to more complete and accurate data and facilitate evidence-informed decision-making and participation in research. Consequently, it should have a positive impact on people's health and should promote trust in health research. Existing initiatives were identified, registration of trials was analyzed following the World Health Organization (WHO) standards on trial registration, and a roadmap is proposed to address the gaps in advancing transparency. The analysis shows that, in spite of numerous regional and country initiatives, clinical trials taking place in nonEnglish-speaking parts of the Americas are underregistered. A roadmap is proposed to enhance research governance and good research practice by improving the transparency of clinical trials. The proposed roadmap includes strategies for implementing WHO international standards for trial registration, for developing international standards of public disclosure of trial results, and for a potential role of the Pan American Health Organization.
本文旨在通过前瞻性注册和结果披露，为美洲临床试验的透明度制定路线图。这将扩大获取更完整和准确数据的途径，并有助于循证决策和参与研究。因此，这将对人们的健康产生积极影响，并促进对健康研究的信任。本文确定了现有的各项举措，按照世界卫生组织（WHO）关于试验注册的标准对试验注册情况进行了分析，并提出了一份路线图，以解决提高透明度方面的差距。分析表明，尽管存在许多区域和国家举措，但在美洲非英语地区进行的临床试验注册数量不足。本文提出了一份路线图，旨在通过提高临床试验的透明度来加强研究治理和良好研究实践。所提出的路线图包括实施世卫组织临床试验注册国际标准、制定临床试验结果公开的国际标准以及泛美卫生组织可能发挥的作用等方面的策略。
