Clinical end points for drug treatment trials in BCR-ABL1-negative classic myeloproliferative neoplasms: consensus statements from European LeukemiaNET (ELN) and Internation Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT)

The discovery of somatic mutations, primarily JAK2V617F and CALR, in classic BCR-ABL1-negative myeloproliferative neoplasms (MPNs) has generated interest in the development of molecularly targeted therapies, whose accurate assessment requires a standardized framework. A working group, comprised of members from European LeukemiaNet (ELN) and International Working Group for MPN Research and Treatment (IWG-MRT), prepared consensus-based recommendations regarding trial design, patient selection and definition of relevant end points. Accordingly, a response able to capture the long-term effect of the drug should be selected as the end point of phase II trials aimed at developing new drugs for MPNs. A time-to-event, such as overall survival, or progression-free survival or both, as co-primary end points, should measure efficacy in phase III studies. New drugs should be tested for preventing disease progression in myelofibrosis patients with early disease in randomized studies, and a time to event, such as progression-free or event-free survival should be the primary end point. Phase III trials aimed at preventing vascular events in polycythemia vera and essential thrombocythemia should be based on a selection of the target population based on new prognostic factors, including JAK2 mutation. In conclusion, we recommended a format for clinical trials in MPNs that facilitates communication between academic investigators, regulatory agencies and drug companies.

Fighting Talk: The Statements of 'The IRA/New IRA'

With the advent of the new violent dissident merger, ‘The IRA/New IRA’, the group and its affiliates have had to legitimise their new existence. They have utilised the maintenance of paramilitary activity to achieve this. However, they have also produced a number of organisational statements, justifying their position, tactics and strategies. This article analyses the evolution of these statements, both pre and post-merger from 2007 to 2015. 126 individual statements and 4 magazines are analysed using grounded theory. This analysis found that the statements have a dual strategy, aiming to foster trust in the movement and distrust in their perceived enemies. One of the dominant ways in which the group aims to foster trust, is by proposing their possession of an historical mandate from the republican forefathers of 1916, as well as the internally lauded paramilitaries from the Troubles era PIRA. The focus of the distrust narrative has been on the ‘constitutional nationalism’ of Sinn Féin. However, it also pours scorn on the PSNI, and capitalism, across the island of Ireland. The analysis of these statements can provide us with an understanding of the future direction of the group, as well as giving us insight, which can inform the development of any counter-narrative.

Why aren't brand names regognized as intangible assets in the financial Statements? A study of the subjectivity of brand valuation

The goal of this paper is to determine and to quantify how subjective brand valuation is. To do so, we review the different valuation methods and apply the Hirose model to a sample of 20 US companies from the technology sector. Even if the results vary in function of the rankings we choose as a comparison, we may identify the trend that brands are usually overvalued in those rankings. It explains why internally generated goodwill (which includes brand names) is not recognized as an intangible asset in the financial statements.

Involving the Public in Public Health Genomics: A Review of Guidelines and Policy Statements

Public health genomics raises exciting possibilities for preventing or reducing the occurrence of both rare and common disease. However, this area of research raises challenging ethical, legal and social issues that must be addressed. One way of addressing these issues is through public involvement in the policy-making process. This GenEdit reviews how international guidelines and policy statements related to public health genomics address the issue of public involvement. Key areas of discussion are the values and goals justifying public involvement, the proposed activities to increase public involvement, who is / who represents "the public", and the projected outcomes of public involvement.