A practical approach to communicating benefit-risk decisions of medicines to stakeholders.

© 2015 Leong, Walker and Salek. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.Purpose: The importance of a framework for a systematic structured assessment of the benefits and risks has been established, but in addition, it is necessary that the benefit-risk decisions and the processes to derive those decisions are documented and communicated to various stakeholders for accountability. Hence there is now a need to find appropriate tools to enhance communication between regulators and other stakeholders, in a manner that would uphold transparency, consistency and standards. Methods: A retrospective, non-comparative study was conducted to determine the applicability and practicality of a summary template in documenting benefit-risk assessment and communicating benefit-risk balance and conclusions for reviewers to other stakeholders. The benefit-risk (BR) Summary Template and its User Manual was evaluated by 12 reviewers within a regulatory agency in Singapore, the Health Sciences Authority (HSA). Results: The BR Summary Template was found to be adequate in documenting benefits, risks, relevant summaries and conclusions, while the User Manual was useful in guiding the reviewer in completing the template. The BR Summary Template was also considered a useful tool for communicating benefit-risk decisions to a variety of stakeholders. Conclusions: The use of a template may be of value for the communicating benefit-risk assessment of medicines to stakeholders.Peer reviewedFinal Published versio

Grilliot's trick in Nonstandard Analysis

The technique known as Grilliot's trick constitutes a template for explicitly defining the Turing jump functional $(\exists^2)$ in terms of a given effectively discontinuous type two functional. In this paper, we discuss the standard extensionality trick: a technique similar to Grilliot's trick in Nonstandard Analysis. This nonstandard trick proceeds by deriving from the existence of certain nonstandard discontinuous functionals, the Transfer principle from Nonstandard analysis limited to $\Pi_1^0$-formulas; from this (generally ineffective) implication, we obtain an effective implication expressing the Turing jump functional in terms of a discontinuous functional (and no longer involving Nonstandard Analysis). The advantage of our nonstandard approach is that one obtains effective content without paying attention to effective content. We also discuss a new class of functionals which all seem to fall outside the established categories. These functionals directly derive from the Standard Part axiom of Nonstandard Analysis.Comment: 21 page

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