IQWIG has released a working paper analyzing clinical trials of medical devices
The paper "Analysis of clinical trials of medical devices" was carried out in cooperation with the State Department of Health and Welfare (LAGeSo) and the office of the Ethics Committee of the State of Berlin (EK Berlin). The objectives of this study were
- to analyze the objectives and methodology of clinical trials of medical devices since the fourth amendment to the Medical Devices Act (MPG)
- to analyze the influence of the relevant Ethics Committee (EC) application on the objectives and methodology of clinical trials of medical devices for evaluation of the initial application and possibly subsequent applications for major changes.
All data were collected anonymously, so no conclusions on the manufacturer or product names were possible. Between March 2010 and December 2013, EK Berlin received requests for 122 clinical trials with medical devices and in vitro diagnostics (IVD). The sample included 98 clinical trials for therapeutic interventions, 14 clinical trials for diagnostic interventions and 10 performance evaluation of IVDs. It was found that in 75 of the 122 studies (61.5%) the respective test product did not yet have CE marking the time of application.
The report concludes that a high proportion of MPG studies were planned as RCT and also considered questioning the effectiveness, which exceeds the regulatory requirements for market access in Europe. The often-expressed concern that RCTs with medical devices are often not feasible, cannot be confirmed.