网络服务提供者( ISP)信息披露制度——以著作权法领域为中心

在信息技术的发展背景下,网络侵权数量呈现直线飙升.关于网络服务提供者间接侵权责任的建立使权利人确认直接侵权人陷入困境.著作权领域的司法和实践为信息披露制度的建立奠定了良好的基础.立足我国的具体实际和网络现状,信息披露制度应当规定包括网络接入服务提供者在内的网络服务提供者均负有一定的信息披露义务,严格信息披露的条件,采用“通知与反通知”的履行方式,明确网络服务提供者信息披露制度下的责任分配,促使网络服务提供者制定统一的信息披露行业规定.     

Combining evidence from clinical trials in conditional or accelerated approval

Conditional (European Medicines Agency) or accelerated (U.S. Food and Drug Administration) approval of drugs allows earlier access to promising new treatments that address unmet medical needs. Certain post-marketing requirements must typically be met in order to obtain full approval, such as conducting a new post-market clinical trial. We study the applicability of the recently developed harmonic mean ${\chi }^2$-test to this conditional or accelerated approval framework. The proposed approach can be used both to support the design of the post-market trial and the analysis of the combined evidence provided by both trials. Other methods considered are the two-trials rule, Fisher's criterion and Stouffer's method. In contrast to some of the traditional methods, the harmonic mean ${\chi }^2$-test always requires a post-market clinical trial. If the $p$-value from the pre-market clinical trial is $\ll 0.025$, a smaller sample size for the post-market clinical trial is needed than with the two-trials rule. For illustration, we apply the harmonic mean ${\chi }^2$-test to a drug which received conditional (and later full) market licensing by the EMA. A simulation study is conducted to study the operating characteristics of the harmonic mean ${\chi }^2$-test and two-trials rule in more detail. We finally investigate the applicability of these two methods to compute the power at interim of an ongoing post-market trial. These results are expected to aid in the design and assessment of the required post-market studies in terms of the level of evidence required for full approval.