General Clinical Studies Unit, Mayo Clinic, Jacksonville, FL, USA.
Contemp Clin Trials. 2014 Mar;37(2):219-24. doi: 10.1016/j.cct.2014.01.001. Epub 2014 Jan 15.
Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection.
临床试验研究是医学成功发展的基石，为未来数以百万计的人带来希望。临床试验的完全透明化可以让独立研究者评估研究设计，对数据进行额外分析，并可能避免重复研究。目前的监管系统和出版商依赖研究者和制药行业来完整、准确地报告已完成临床试验的结果。立法似乎是强制披露结果的唯一途径。2012 年，《试验和实验研究透明度法案》（TEST Act）被提交给美国立法者，以提高研究行业的透明度。公共安全和科学进步是推动政策变革的动力。TEST 法案可能使社会和研究人员受益，但参与者的隐私和知识产权保护是主要关切。
