Are RCTs becoming standard in medical device research? - The IQWiG is optimistic

Fri, 2018 / 02 / 02

About the author

Ihre Ansprechpartnerin Dipl.-Kauffrau Heike Kielhorn-Schönermark

Dipl.-Kauffrau Heike Kielhorn-Schönermark
Founder and Managing Director

Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18

E-Mail More Contact Info

For the approval of new drugs, RCTs (randomized controlled trials) are highly recommended by pharmaceutical companies at least since the AMNOG and the associated early benefit assessment (§ 35a SGB V) and thus have largely become the norm. In case of medical devices, however, the studies and their main results, which are necessary for the certification of the devices, usually remain unpublished, resulting in currently little transparency about study design and level of evidence.

For the first time, the IQWiG analyzed 122 applications for approval of clinical trials of medical devices at the Ethics Committee Berlin from the years 2010 to 2013 and presented the results in a working paper. In summary, a total of 98 applications for new therapies and 24 for diagnostics were evaluated. For therapeutic interventions, around 70% of studies were planned as RCTs, with an increasing number over time, so that the proportion of RCTs among the applications submitted in 2013 was already at 86%. Overall, 57% of the studies were planned as RCTs. Also, other study design aspects such as blinding of the participants of the study and investigators as well as the definition of patient-relevant primary endpoints surprised the experts, as they go beyond the current requirements for the CE certification.

However, it remains unclear, if the samples used for analysis are representative and whether the studies were actually carried out in accordance with the applications. Though, the results of the IQWiG give a hint, that there is a change in the study design for medical devices. In addition to this, the publication of the main study results for medical devices will be made obligatory by the new EU Medical Devices Directive, which should be implemented by 2020. Yet, it remains to be seen how fast a regular publication of the results will take place. But it seems certain that among other things due to this new regulation, the requirements regarding reliable study results applies an increased pressure on the manufacturers and an early anticipation of this change could become a strategic advantage.

BY Heike Kielhorn-Schönermark, MBA, Founder and Managing Director of SKC Beratungsgesellschaft mbH and Thora Mrosowsky, M. Sc. Health Economics, SKC Beratungsgesellschaft mbH

You will find more information on this topic here:

IQWiG: RCTs sind auch bei Medizinprodukten Standard (German only)

IQWiG: Analyse klinischer Prüfungen von Medizinprodukten (German only)