In Part I, Chapter 1 at paras 1.22 ff, we set out the context in which the Bank Recovery and Resolution Directive (BRRD) was drafted and how it aims to harmonize, in short, substantive bank insolvency law. Together with the Single Resolution Mechanism Regulation (SRMR), the BRRD forms the second pillar of the Banking Union and intends ‘[t]o provide authorities with a credible set of tools to intervene sufficiently early and quickly in an unsound or failing institution as to ensure the continuity of the institution’s critical financial and economic functions, while minimising the impact of the institution’s failure on the economy and financial system’ (recital (15)). The BRRD had to be implemented into national law by 31 December 2014.
Until 2009, the European law of insurance was set out in a plethora of different Directives. The key legislation dealing with insurance insolvency was Directive 2001/17/EC on the reorganisation and winding-up of insurance undertakings (IWUD).
ObjectiveTo evaluate the reporting and rates of loss to follow‐up (LTFU) in head and neck cancer (HNC) randomized controlled trials based in the United States.Data SourcesPubmed/MEDLINE, Cochrane, Scopus databases.Review MethodsA systematic review of titles in Pubmed/MEDLINE, Scopus, and Cochrane Library was performed. Inclusion criteria were US‐based randomized controlled trials focused on the diagnosis, treatment, or prevention of HNC. Retrospective analyses and pilot studies were excluded. The mean age, patients randomized, publication details, trial sites, funding, and LTFU data were recorded. Reporting of participants through each stage of the trial was documented. Binary logistic regression was performed to evaluate associations between study characteristics and reporting LTFU.ResultsA total of 3255 titles were reviewed. Of these, 128 studies met the inclusion criteria for analysis. A total of 22,016 patients were randomized. The mean age of participants was 58.6 years. Overall, 35 studies (27.3%) reported LTFU, and the mean LTFU rate was 4.37%. With the exception of 2 statistical outliers, study characteristics including publication year, number of trial sites, journal discipline, funding source, and intervention type did not predict the odds of reporting LTFU. Compared to 95% of trials reporting participants at eligibility and 100% reporting randomization, only 47% and 57% reported on withdrawal and details of the analysis, respectively.ConclusionThe majority of clinical trials in HNC in the United States do not report LTFU, which inhibits the evaluation of attrition bias that may impact the interpretation of significant findings. Standardized reporting is needed to evaluate the generalizability of trial results to clinical practice.
This chapter provides a commentary on the ‘original’ Regulation on Insolvency Proceedings (OR) and the Recast Regulation (RR). It first highlights how the OR is not only intended to deal with the fact that insolvencies increasingly have cross-border aspects but is also intended to be one element in the progress towards a complete and free internal market between all the Member States. With its application to collective insolvency proceedings which entail the partial or total divestment of a debtor and the appointment of a liquidator, the OR encompasses four elements: the proceedings must be collective; the proceedings must be insolvency proceedings; the proceedings must entail the total or partial divestment of the debtor; and the proceedings must entail the appointment of a liquidator. The chapter then turns to the RR, where it analyses some of the changes, such as the newly-proposed three types of proceedings which fall under the RR.
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