Practical and conceptual issues of clinical trial registration for Brazilian researchers

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

研究背景与目的：临床试验注册是在权威科学期刊发表论文的前置条件。巴西近期出台的法规也要求部分临床试验需在巴西临床试验注册库（ReBEC）完成注册，但目前关于注册流程中实际操作问题的公开信息较为匮乏。本文探讨了临床试验注册的重要性及其流程中涉及的实际操作问题。
研究设计与研究场所：本研究为描述性研究，由巴西圣保罗一所公立大学研究生院的研究人员开展。
研究方法：本研究从临床试验注册平台、论文参考文献列表及相关网站（末次检索时间：2014年9月）收集了以下主题的相关信息：临床试验的定义、注册平台的发展历史、宗旨与重要性、需注册的信息内容及注册流程。
研究结果：临床试验注册的核心目的在于规避发表偏倚，巴西收录于拉丁美洲与加勒比健康科学文献库（LILACS）、科学电子图书馆在线（SciELO）的期刊，以及隶属于国际医学期刊编辑委员会（ICMJE）的期刊均要求进行临床试验注册。巴西最新法规要求，所有拟在本国上市的新药相关临床试验（I至IV期）均需在巴西临床试验注册库（ReBEC）完成注册。本文同时探讨了不同临床试验注册平台的优劣之处。
研究结论：临床试验注册具有重要意义，目前已有多种机制可推动其落地执行。研究人员在选择临床试验注册平台时，应综合考量本国相关法规与期刊发表要求。