Final_Lassman et al Data Tables and Analysis

The data file contains, among other details, sponsor, study ID, registration timing, and results reporting information for each of the 15 drugs included in our reanalysis of the following paper: Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015; 5: e009758. doi:10. 1136/bmjopen-2015-009758. The data file also contains our compliance calculations and flags the differences, per trial, between our reanalysis and the findings of the original study.

本数据文件除包含其他相关细节外，还收录了我们对下述论文进行再分析时纳入的15种药物的资助方（sponsor）、研究编号（study ID）、注册时机以及结果报告信息。相关论文信息如下：Miller JE、Korn D、Ross JS. 《临床试验注册、报告、发表与FDAAA合规性：2012年美国食品药品监督管理局（Food and Drug Administration, FDA）批准新药的横断面分析与排名》，《BMJ Open》，2015年；5卷：e009758，数字对象标识符（Digital Object Identifier, DOI）：10.1136/bmjopen-2015-009758。本数据文件同时包含我们的合规性计算结果，并标记了每项试验中本研究再分析结果与原始研究结论之间的差异。