Foote MaryAnn
Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA.
Biotechnol Annu Rev. 2003;9:303-13. doi: 10.1016/s1387-2656(03)09009-4.
Publication of clinical trial data is the final step in the scientific method and an important method by which pharmaceutical and biotechnology companies, i.e., drug sponsors, disseminate information about their products. Because of the nature of large, multicenter trials, multiple investigators from many institutions may be considered as authors of these papers. Controversy concerning the rights of academic institutions and the rights of drug sponsors has been widely debated. This chapter summarizes the controversy and the current policies.
临床试验数据的发表是科学方法的最后一步，也是制药和生物技术公司（即药物申办者）传播其产品信息的重要方式。由于大型多中心试验的性质，来自许多机构的多名研究人员可能会被视为这些论文的作者。关于学术机构的权利和药物申办者的权利的争议一直备受广泛讨论。本章总结了这一争议及当前政策。
