Remuneration for non-interventional studies – results of a survey in the pharmaceutical industry in Germany

In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center

Remuneration for non-interventional studies – results of a survey in the pharmaceutical industry in Germany

In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center

Visual Analysis of Spatio-Temporal Event Predictions: Investigating the Spread Dynamics of Invasive Species

Invasive species are a major cause of ecological damage and commercial losses. A current problem spreading in North America and Europe is the vinegar fly Drosophila suzukii. Unlike other Drosophila, it infests non-rotting and healthy fruits and is therefore of concern to fruit growers, such as vintners. Consequently, large amounts of data about infestations have been collected in recent years. However, there is a lack of interactive methods to investigate this data. We employ ensemble-based classification to predict areas susceptible to infestation by D. suzukii and bring them into a spatio-temporal context using maps and glyph-based visualizations. Following the information-seeking mantra, we provide a visual analysis system Drosophigator for spatio-temporal event prediction, enabling the investigation of the spread dynamics of invasive species. We demonstrate the usefulness of this approach in two use cases

Resolution der CDU/CSU-Mittelstandsvereinigung "Obligatorische Urabstimmung unter Kontrolle des Staates"

Die Forderung der CDU/CSU-Mittelstandsvereinigung nach der Einführung einer obligatorischen Urabstimmung vor dem Beginn eines Streiks wird von Dr. Dieter Hundt, Präsident der Bundesvereinigung der Deutschen Arbeitgeber abgelehnt: "Der Beschluss der CDU/CSU-Mittelstandsvereinigung zur Einführung einer obligatorischen Urabstimmung vor der Durchführung von Streikmaßnahmen wirkt auf den ersten Blick viel versprechend. Auf den zweiten Blick erweist er sich jedoch als kontraproduktiv. Im Ergebnis bedeutet er mehr kollektiven Zwang und weniger arbeitsrechtliche Gestaltungsmöglichkeiten für Arbeitgeber und Arbeitnehmer." Auch Michael Sommer, Vorsitzender des Deutschen Gewerkschaftsbundes, wendet sich gegen diese Forderung, da sie "… die Funktion von Koalitionsfreiheit, Tarifautonomie, Tarifverträgen und deren Aushandlung völlig (verkenne)." Dr. Manfred C. Hettlage begründet hingegen in seinem Beitrag diese Resolution.Streik, Staat, Arbeitskonflikt, Tarifvertrag, Tarifautonomie, Deutschland

Non-sexist Language Policy and the Rise (and Fall?) of Combined Pronouns in British and American Written English

This paper focuses on the use of combined pronouns (s/he, his or her, him/her, etc.) as an example of late twentieth-century non-sexist language reform which had an overt democratizing aim. Within the scope of second-wave feminism, the use of combined pronouns increased the visibility of women in discourse by encouraging the use of feminine pronouns (she, her, hers) alongside masculine pronouns (he, him, his). Despite their promotion, however, the use of combined pronouns is relatively rare. This paper uses the LOB and Brown families of corpora to diachronically and synchronically study patterns in the use of combined pronouns in written American (AmE) and British English (BrE) from the 1930s to the early 2000s. The analysis not only determines what forms these patterns take, but questions whether combined pronouns are influenced by (a combination of) syntax and/or semantics, and questions whether combined pronouns are really democratic at all

Genetic Associations and Differential mRNA Expression Levels of Host Genes Suggest a Viral Trigger for Endemic Pemphigus Foliaceus

The long search for the environmental trigger of the endemic pemphigus foliaceus (EPF, fogo selvagem) has not yet resulted in any tangible findings. Here, we searched for genetic asso ciations and the differential expression of host genes involved in early viral infections and innate antiviral defense. Genetic variants could alter the structure, expression sites, or levels of the gene products, impacting their functions. By analyzing 3063 variants of 166 candidate genes in 227 EPF patients and 194 controls, we found 12 variants within 11 genes associated with differential suscepti bility (p < 0.005) to EPF. The products of genes TRIM5, TPCN2, EIF4E, EIF4E3, NUP37, NUP50, NUP88, TPR, USP15, IRF8, and JAK1 are involved in different mechanisms of viral control, for example, the regulation of viral entry into the host cell or recognition of viral nucleic acids and proteins. Only two of nine variants were also associated in an independent German cohort of sporadic PF (75 patients, 150 controls), aligning with our hypothesis that antiviral host genes play a major role in EPF due to a specific virus–human interaction in the endemic region. Moreover, CCL5, P4HB, and APOBEC3G mRNA levels were increased (p < 0.001) in CD4+ T lymphocytes of EPF patients. Because there is limited or no evidence that these genes are involved in autoimmunity, their crucial role in antiviral responses and the associations that we observed support the hypothesis of a viral trigger for EPF, presumably a still unnoticed flavivirus. This work opens new frontiers in searching for the trigger of EPF, with the potential to advance translational research that aims for disease prevention and treatment

CD95 co-stimulation blocks activation of naive T cells by inhibiting T cell receptor signaling

CD95 is a multifunctional receptor that induces cell death or proliferation depending on the signal, cell type, and cellular context. Here, we describe a thus far unknown function of CD95 as a silencer of T cell activation. Naive human T cells triggered by antigen-presenting cells expressing a membrane-bound form of CD95 ligand (CD95L) or stimulated by anti-CD3 and -CD28 antibodies in the presence of recombinant CD95L had reduced activation and proliferation, whereas preactivated, CD95-sensitive T cells underwent apoptosis. Triggering of CD95 during T cell priming interfered with proximal T cell receptor signaling by inhibiting the recruitment of ζ-chain–associated protein of 70 kD, phospholipase-γ, and protein kinase C-θ into lipid rafts, thereby preventing their mutual tyrosine protein phosphorylation. Subsequently, Ca2+ mobilization and nuclear translocation of transcription factors NFAT, AP1, and NF-κB were strongly reduced, leading to impaired cytokine secretion. CD95-mediated inhibition of proliferation in naive T cells could not be reverted by the addition of exogenous interleukin-2 and T cells primed by CD95 co-stimulation remained partially unresponsive upon secondary T cell stimulation. HIV infection induced CD95L expression in primary human antigeen-presenting cells, and thereby suppressed T cell activation, suggesting that CD95/CD95L-mediated silencing of T cell activation represents a novel mechanism of immune evasion

Risk governance in organizations

Dieses Buch dokumentiert 10 Jahre Risk-Governance-Forschung an der Universität Siegen. In 50 Beiträgen reflektieren Forscher und Praktiker Risk Governance vor dem Hintergrund ihrer eigenen Forschungen und/oder Erfahrungen und geben jeweils einen Entwicklungsimpuls für die Zukunft der Risk Governance. Das Buch zeigt die große Bandbreite und Tiefe des Forschungsgebietes auf und diskutiert Grundannahmen, Implementierungsfragen, die Rolle der Risk Governance als Transformationsmotor, ihre Wirkung in den verschiedenen betrieblichen Funktionen, Entwicklungsperspektiven und den Beitrag der Risk Governance zu einer nachhaltigen Ausrichtung von Unternehmen.This book documents 10 years of risk governance research at the University of Siegen. In 50 contributions, researchers and practitioners reflect on risk governance against the background of their own research and/or experience and provide a development impetus for the future of risk governance. The book shows the wide range and depth of the research field and discusses basic assumptions, implementation issues, the role of risk governance as transformation engine, its impact in the various operational functions, development perspectives, and the contribution of risk governance to a sustainable orientation of companies