Need of reduced and harmonized bureaucracy in multi-centre clinical research - a case-report from a Swiss trial

Introduction We launched an investigator-initiated study(ISRCTN31181395) to evaluate the potential benefit of pharmacokinetic-guided dosage individualization of imatinib for leukaemia patients followed in public and private sectors. Following approval by the research ethics committee (REC) of the coordinating centre, recruitment throughout Switzerland necessitated to submit the protocol to 11 cantonal RECs.Materials and Methods We analysed requirements and evaluation procedures of the 12 RECs with associated costs.Results 1-18 copies of the dossier, in total 4300 printed pages, were required (printing/posting costs: ~300 CHF) to meet initial requirements. Meeting frequencies of RECs ranged between 2 weeks and 2 months, time from submission to first feedback took 2-75 days. Study approval was obtained from a chairman, a subor the full committee, the evaluation work being invoiced by 0-1000 CHF (median: 750 CHF, total: 9200 CHF). While 5 RECs gave immediate approval, the other 6 rose in total 38 queries before study release, mainly related to wording in the patient information, leading to 7 different final versions approved. Submission tasks employed an investigator half-time over about 6 months.Conclusion While the necessity of clinical research evaluation by independent RECs is undisputed, there is a need of further harmonization and cooperation in evaluation procedures. Current administrative burden is indeed complex, time-consuming and costly. A harmonized electronic application form, preferably compatible with other regulatory bodies and European countries, could increase transparency, improve communication, and encourage academic multi-centre clinical research in Switzerland.

Need of reduced and harmonized bureaucracy in multi-centre clinical research - a case-report from a Swiss trial

Introduction: We launched an investigator-initiated study (ISRCTN31181395) to evaluate the potential benefit of pharmacokinetic-guided dosage individualization of imatinib for leukaemiapatients followed in public and private sectors. Following approval by the research ethics committee (REC) of the coordinating centre, recruitment throughout Switzerland necessitatedto submit the protocol to 11 cantonal RECs.Materials and Methods: We analysed requirements and evaluation procedures of the 12 RECs with associated costs.Results: 1-18 copies of the dossier, in total 4300 printed pages, were required (printing/posting costs: ~300 CHF) to meet initial requirements. Meeting frequencies of RECs ranged between 2 weeks and 2 months, time from submission to fi rst feedback took 2-75 days. Study approval was obtained from a chairman, a subor the full committee, the evaluation work being invoiced by0-1000 CHF (median: 750 CHF, total: 9200 CHF). While 5 RECs gave immediate approval, the other 6 rose in total 38 queries before study release, mainly related to wording in the patient information, leading to 7 different fi nal versions approved. Submission tasks employed an investigator half-time over about 6 months.Conclusion: While the necessity of clinical research evaluation by independent RECs is undisputed, there is a need of further harmonization and cooperation in evaluation procedures. Current administrative burden is indeed complex, time-consuming and costly. A harmonized electronic application form, preferably compatible with other regulatory bodies and European countries, could increase transparency, improve communication, and encourage academic multi-centre clinical research in Switzerland.

A road map toward a globally harmonized approach for occupational health surveillance and epidemiology in nanomaterial workers

OBJECTIVE: Few epidemiological studies have addressed the health of workers exposed to novel manufactured nanomaterials. The small current workforce will necessitate pooling international cohorts. METHOD: A road map was defined for a globally harmonized framework for the careful choice of materials, exposure characterization, identification of study populations, definition of health endpoints, evaluation of appropriateness of study designs, data collection and analysis, and interpretation of the results. RESULTS: We propose a road map to reach global consensus on these issues. The proposed strategy should ensure that the costs of action are not disproportionate to the potential benefits and that the approach is pragmatic and practical. CONCLUSIONS: We should aim to go beyond the collection of health complaints, illness statistics, or even counts of deaths; the manifestation of such clear endpoints would indicate a failure of preventive measures.

On-line teaching and Copyright : Any Hopes for an EU Harmonized Playground?

Education never fails to be mentioned ¿ and, often, mentioned first ¿ as a public interest that justifies an exception to copyright. Educational purposes were already present in the first version of the Berne Convention of 18862 and have remained there (although in revised language) ever since. The WIPO Copyright Treaty of 19963 expressly referred to education in its Preamble, when ¿Recognizing the need to maintain a balance between the rights of authors andthe larger public interest, particularly education, research and access to information, as reflected in the Berne Convention¿ (emphasis added). And morerecently, the EU Directive on Copyright in the Information Society4 stressed its goal ¿to promote learning and culture by protecting works and other subjectmatter while permitting exceptions or limitations in the public interest for the purpose of education and teaching¿ (Recital 14, emphasis added).

Harmonized performance measurement system for basic industry's service centers

The objective of this study is to create measurement system that is capable to measure performance in basic industry’s service centers. First it is examined what is performance and how it can be measured. The study also introduces commonly known measurement frameworks. After theory the study investigates how companies in the field of basic industry measure their operations in practise. The investigation is done examining three case examples and by analyzing survey results from basic industry companies. On the survey results focus is on what meters and measurement systems companies use. It is also viewed what measurement problems companies have faced. In the applied part of the study harmonized performance measurement system is created. The framework of the measurement system is introduced and measurement system for the target company is created. The target company felt that the harmonized performance measurement system has good potential and continues to develop it further.

A Harmonized Vocabulary For Water Quality

Interoperability of water quality data depends on the use of common models, schemas and vocabularies. However, terms are usually collected during different activities and projects in isolation of one another, resulting in vocabularies that have the same scope being represented with different terms, using different formats and formalisms, and published in various access methods. Significantly, most water quality vocabularies conflate multiple concepts in a single term, e.g. quantity kind, units of measure, substance or taxon, medium and procedure. This bundles information associated with separate elements from the OGC Observations and Measurements (O&M) model into a single slot. We have developed a water quality vocabulary, formalized using RDF, and published as Linked Data. The terms were extracted from existing water quality vocabularies. The observable property model is inspired by O&M but aligned with existing ontologies. The core is an OWL ontology that extends the QUDT ontology for Unit and QuantityKind definitions. We add classes to generalize the QuantityKind model, and properties for explicit description of the conflated concepts. The key elements are defined to be sub-classes or sub-properties of SKOS elements, which enables a SKOS view to be published through standard vocabulary APIs, alongside the full view. QUDT terms are re-used where possible, supplemented with additional Unit and QuantityKind entries required for water quality. Along with items from separate vocabularies developed for objects, media, and procedures, these are linked into definitions in the actual observable property vocabulary. Definitions of objects related to chemical substances are linked to items from the Chemical Entities of Biological Interest (ChEBI) ontology. Mappings to other vocabularies, such as DBPedia, are in separately maintained files. By formalizing the model for observable properties, and clearly labelling the separate concerns, water quality observations from different sources may be more easily merged and also transformed to O&M for cross-domain applications.

Adjustment methods of national input-output tables for harmonized and consistent multi-regional input-output databases

Despite the fact that input–output (IO) tables form a central part of the System of National Accounts, each individual country's national IO table exhibits more or less different features and characteristics, reflecting the country's socioeconomic idiosyncrasies. Consequently, the compilers of a multi-regional input–output table (MRIOT) are advised to thoroughly examine the conceptual as well as methodological differences among countries in the estimation of basic statistics for national IO tables and, if necessary, to carry out pre-adjustment of these tables into a common format prior to the MRIOT compilation. The objective of this study is to provide a practical guide for harmonizing national IO tables to construct a consistent MRIOT, referring to the adjustment practices used by the Institute of Developing Economies, JETRO (IDE-JETRO) in compiling the Asian International Input–Output Table.

First steps toward harmonized human biomonitoring in Europe : demonstration project to perform human biomonitoring on a European scale

'Reproduced with permission from Environmental Health Perspectives'