The aim of this advisory report is to increase awareness of the methodology concerning human-related research during the introduction of medical technologies ('devices') in healthcare.

The committee will make recommendations for ethical research methods for the introduction of such innovative technologies. These may include new 'designs', analysis methods, other end points, as well as performing relatively small studies that will facilitate a rapid exchange of information. The recommendations will be substantiated by methodological and statistical knowledge. The committee will set out its findings in a foresight study.

The current methods for human-related research using medical innovation technologies (devices) mean that assessing the effectiveness (in terms of improved patient results) of technologies is very difficult. As a result, speedy implementation in clinical practice is occasionally not possible on the one hand, and technologies are sometimes implemented too rapidly on the other. The Netherlands has a great deal of expertise in clinical research and has built up an excellent international reputation with regard to the methodology for setting up, performing and analysing this clinical research.

The committee will focus mainly on the following question:

In what way can improvements in the methodology of clinical research for medical technologies ('devices') enhance the introduction in healthcare?

Advice such as this is intended in the first instance for professions (doctors and researchers) and developers of new technologies, but it is also aimed at assessment and evaluation committees, such as those of NWO (ZONMW), CCMO and METCs.

Activities and planning

The committee will ensure that the report is submitted to the Academy Board no later early 2013.

Duration

2011-2013