Benefit studies on medical devices are both feasible and necessary
Contrary to what the manufacturers of medical devices often assert, these benefit studies are feasible. According to Jrgen Windeler: "If you take the patient's safety seriously, you have to insist on these studies. Antibody-stents have been used for many years, but we don't know how many patients have received this intervention. It is only now that we learn that its harm outweighs its benefit."
Procedure of report production
The G-BA commissioned IQWiG to prepare the report in an accelerated process, known as a "rapid report". Unlike the normal procedure, no preliminary reports are published in this case. Although a draft version of the report is reviewed by external experts, no hearing at which all interested parties can comment takes place.
The first report (Version 1.0) was prepared in the middle of August 2012 and sent to the G-BA. Shortly afterwards, the Institute was sent additional and previously unpublished data on the decisive study TRIAS-HR, which had been requested by the Institute from the responsible research group in Amsterdam (data on the overall rate of myocardial infarctions and revascularization). The report was then revised and Version 1.1 sent to the G-BA at the start of September 2012.
|Contact: Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care