Trends and Variation in Data Quality on the EU Clinical Trials Register: A Cross-Sectional Study

The EU Clinical Trial Register (EUCTR) is a public facing portal containing information on trials of medicinal products conducted in the European Union (EU) and European Economic Area (EEA). Today, the registry holds information on over 30,000 trials. Given its distinct regulatory purpose, and results reporting requirements, the EUCTR should be a valuable open-source hub for trial information. Past work examining the EUCTR has suggested that data quality on the registry may be lacking. Using the full EUCTR public dataset, we examined areas in which national regulators are expected to ensure data quality including the posting of registrations, updating trial completion information, and monitoring results posting in line with EU guidelines. We identified issues across all areas examined with notable research hubs like France, Spain, and The Netherlands lacking consistent and complete data on the registry. These deficiencies complicate the utility of the EUCTR for research, transparency, and accountability efforts.

PERMISSION TO ACT: THE LEGAL CHARACTER OF GENERAL AND SECURITY EXCEPTIONS IN INTERNATIONAL TRADE AND INVESTMENT LAW

The dyadic rule–exception structure common to many legal systems has posed particular interpretive difficulties in international trade and investment law. Adjudicators have interpreted general and security exceptions in GATT, GATS and cognate provisions of investment treaties in divergent ways, and the analytic character of these provisions is under-theorised in the literature. This article argues that we should understand exceptions from a deontological perspective as permissions that affirm governmental regulatory capacity and thus limit the scope of the commands set out in the treaty. This characterisation of exceptions has both symbolic and practical implications, of which this article discusses two: determining the exception's applicability as a preliminary matter rather than as a defence, which would in turn permit consideration of regulatory purpose at the point of obligation; and whether the applicability of an exception is properly a question of merits or jurisdiction.

Smart Contracts

The main purpose of this chapter is to sketch two principal ways in which lawyers are likely to engage with new transactional technologies (such as smart contract applications of blockchain technologies), each form of engagement being characterized by its own questions and conversations. Whereas one form of engagement, ‘coherentism’, focuses on the fit between particular new technologies and the covering law of contract, the other, ‘regulatory-instrumentalism’, focuses on whether the law (relative to particular new technologies) is fit for regulatory purpose. The sketch is refined by drawing further distinctions between ‘transactionalist’ and ‘relationalist’ variants of ‘coherentism’ and ‘rule-based’ and ‘technocratic’ variants of regulatory-instrumentalism. With a view to decoding legal debates about emerging transactional technologies, this sketch is then applied to questions concerning smart contracts in, respectively, business-to-consumer, business-to-business, and peer-to-peer transactions.

Gutting a good idea

This chapter provides a critical and analytical history of custody visiting, centring on the policy issues, and compiled from desk and archival research. Michael Meacher MP made the first proposals for custody visiting in 1980, and in 1981 the Scarman Report on the Brixton riots adopted this idea and included a recommendation for a statutory scheme of custody visiting. The scheme would provide for the supervision of the conditions of police interrogation and detention. The government declined to implement the proposals. However the government encouraged the growth of custody visiting from 1984 on the rather haphazard and unofficial basis known as ‘lay visiting’, run by police authorities. A statutory scheme was introduced in 2003. Over the whole period to date, the powerful influence of the police, and the Home Office following their views, have eroded the original regulatory purpose of custody visiting, and has airbrushed out the role of custody visiting as a deterrent to police misconduct leading to deaths in custody.

Dual functions of a small regulatory subunit in the mitochondrial calcium uniporter complex

Mitochondrial Ca2+ uptake, a process crucial for bioenergetics and Ca2+ signaling, is catalyzed by the mitochondrial calcium uniporter. The uniporter is a multi-subunit Ca2+-activated Ca2+ channel, with the Ca2+ pore formed by the MCU protein and Ca2+-dependent activation mediated by MICU subunits. Recently, a mitochondrial inner membrane protein EMRE was identified as a uniporter subunit absolutely required for Ca2+ permeation. However, the molecular mechanism and regulatory purpose of EMRE remain largely unexplored. Here, we determine the transmembrane orientation of EMRE, and show that its known MCU-activating function is mediated by the interaction of transmembrane helices from both proteins. We also reveal a second function of EMRE: to maintain tight MICU regulation of the MCU pore, a role that requires EMRE to bind MICU1 using its conserved C-terminal polyaspartate tail. This dual functionality of EMRE ensures that all transport-competent uniporters are tightly regulated, responding appropriately to a dynamic intracellular Ca2+ landscape.