Targeted combination therapies in oncology: Challenging regulatory frameworks designed for monotherapies in Europe.

The pharmaceutical value chain, including clinical trials, pricing, access, and reimbursement, is designed for classical monotherapies. Although there has been a paradigm shift that increases the relevance of targeted combination therapies (TCTs), regulation and common practice have been slow to adapt. We explored access to 23 TCTs for advanced melanoma and lung cancer as reported by 19 specialists from 17 leading cancer institutions in nine European countries. We find heterogeneous patient access to TCTs between countries, differences in country-specific regulations, and differences in the clinical practice of melanoma and lung cancer. Regulation that is better tailored to the context of combinational therapies can increase equity in access across Europe and promote an evidence-based and authorized use of combinations.

Benchmarking biology research organizations using a new, dedicated tool.

International competition forces fundamental research organizations to assess their relative performance. We present a benchmark tool for scientific research organizations where, contrary to existing models, the group leader is placed in a central position within the organization. We used it in a pilot benchmark study involving six research institutions. Our study shows that data collection and data comparison based on this new tool can be achieved. It proved possible to compare relative performance and organizational characteristics and to generate suggestions for improvement for most participants. However, strict definitions of the parameters used for the benchmark and a thorough insight into the organization of each of the benchmark partners is required to produce comparable data and draw firm conclusions.

Early phase Technology Assessment of nanotechnology in oncology.

To perform early Technology Assessment (TA) of nanotechnology in oncology. The possibilities of nanotechnology for detection (imaging), diagnosis and treatment of cancer are subject of different research programs where major investments are concerned. As a range of bio- nanotechnologies is expected to enter the oncology field it is relevant to consider the various aspects involved in especially early TA. This article provides two cases of early assessment of (predecessors of) nanotechnologies: Microarray Analysis and Photodynamic Therapy implementation, which methodology can be extrapolated to other nanotechnologies in oncology. Constructive Technology Assessment (CTA) is used for the introduction of technologies that are still in a dynamic phase of development or in an early stage of diffusion. The selection of studied aspects in CTA is based on: clinical aspects (safety, efficacy, and effectiveness), economic (cost-effectiveness), patient related (QoL, ethical/juridical and psychosocial), organizational aspects (diffusion and adoption) and scenario drafting. The features of the technology and the phase of implementation are decisive for choices and timing of the specific aspects to be studied. A framework was drafted to decide on the relevant aspects. In the first case, early implementation of Microarray Analysis; clinical effectiveness, logistics, patient centeredness and scenario drafting were given priority. Related to the diffusion-phase of Photodynamic Therapy however other aspects were evaluated, such as early cost-effectiveness analysis for possible reimbursement. Often CTA will result in a mixed method design. Especially scenario drafting is a powerful instrument to predict possible developments that can be anticipated upon in the assessment. CTA is appropriate for the study of early implementation of new technologies in oncology. In early TA small series often necessitate a mix of quantitative and qualitative methods. The features of nanotechnology involved are decisive for the selection of CTA aspects, most likely: safety -especially possible interactions with other technologies-, ethics, cost-effectiveness and patient centeredness.

Strategic behaviour of institutional providers in mental handicapped care in the Netherlands.

PURPOSE: The purpose of this paper is to describe an inventory of the strategic responses of institutional providers of mental handicapped care to the strengthening of consumer choice through a personal care budget (PCB). DESIGN/METHODOLOGY/APPROACH: Semi structured interviews were conducted among 26 providers covering 52 per cent of the total market volume of about 100,000 clients annually. FINDINGS: A representative number of providers was included; on average a percentage below the national average of PCB users was found to be served. Of the 26 providers, 16 indicated adaption to their strategy in response to expected consumer empowerment The actual deployment of this response in the organisations seemed not to be very thorough or explicit. Surprisingly, as a growing part of PCB-clients choose alternative providers, no concerns were raised concerning the possible emergence of new service providers. ORIGINALITY/VALUE: Although the market share of PCB users is growing fast and existing providers do not seem to absorb this accordingly, a lack of market analysis and strategic behaviour of the traditional providers in response to this development was found. Based on this research growth of market shares of disruptive service providers can very well be anticipated.

The evaluation of the introduction of a quality management system: a process-oriented case study in a large rehabilitation hospital.

OBJECTIVES: So far, there is limited proof concerning the effects of the introduction of quality management systems (QMS) on organisational level. This study concerns the introduction of a QMS in a large rehabilitation hospital. METHODS: Using an observational framework, a process-analysis is performed. The effects were analysed with repeated analyses using the Dutch version of the EFQM-model. RESULTS: The introduction of a QMS can be seen as a change process; the pre-change diagnosis proved to be essential. Although many change-related aspects are vital, training and communication, in particular, seemed to be underestimated. Outcomes are a positive correlation between participation in quality activities and work satisfaction and a repeatedly favourable EFQM-score (compared to national levels). CONCLUSIONS: Through a process-analysis, information could be generated to guide organisations in introducing a QMS. An outcome analysis revealed positive effects both in the EFQM-score and the staff's work satisfaction.