Looking over a year’s worth of events, there have been several in 2014 at European as well as national level that will have an impact on medical device clinical studies in Europe moving into 2015.
Below you find a selection:
- March – EU parliament supports EU data protection reform
- April – EU parliament adopts MDR text of 22 October 2013
- April – EU adopts new Clinical Trial Regulation for medicinal products
- June – Commission working document Joint plan for immediate actions under the current MDD
- June – KNAW report on the evaluation of new technologies in health care
- July – new Code of Conduct for Notified Bodies
- September – Wilmott new MDD revision rapporteur
- October – EMA released their policy on publication of clinical data
- November – NIH publishes request for comments on policy on dissemination of clinical trial registration and submission of summary results.
- November – Buttarelli new EU Data Protection revision supervisor
- December – Medical Devices Policy moved to DG Enterprise
How the above exactly translates to medical device clinical studies in Europe in 2015, one can only guess, but for sure 4 trends can be distilled from it.
Clinical Evidence Demands for clinical evidence will further increase; As previously blogged, the revised MDD is looking to ensure more solid clinical data supporting medical device safety and performance at market release preferably on efficacy and collected through randomised clinical trials. A direction that for sure has Wilmott’s support and may face some delays due to the move to DG Enterprise in formalisation, but already gets immediate attention via better qualified Notified Bodies that started conducting unannounced audits of device manufacturers this year.
Clinical data transparency There is also an increasing call for more transparency on the clinical data supporting device performance: Under the revised MDD the EUDAMED database (among many other things) is meant to register all medical device clinical trials in the EU. Similar to EMAs policy, this should include a summary of the clinical trial results available for public review. Although full implementation of EUDAMED may seem far away, EMA is not the only one with more strict policies in that respect. Similar trends are present with respect to clinical data supporting publications, and journals will require more and more that raw data are made publically available once the manuscript is published. So clinical study sponsors should carefully consider what, when, and how to present their clinical study data to the public moving forward, as we are beyond the point where one can choose not to.
Personal data The call for full clinical data transparency creates tension in the area of personal data protection. Especially when striving for full transparency on raw clinical data, one needs to be extremely careful ensuring full anonymisation of subject data or the explicit free and informed written consent of the concerning subjects. A topic that does have the attention in the reform of the EU law on data protection and we can be sure that moving forward the Informed Consent process in clinical studies will get even more attention than it already did. Even more so with the continuing globalisation of clinical studies and thereby an increased flow of clinical data to countries outside of the EU that may have different rules with respect to personal data protection.
Monitoring The revised MDD will guard better monitoring of device safety in daily practise through more stringent postmarket surveillance plans including post-market clinical follow-up, and mandatory annual updates of the clinical performance for the Notified Bodies and the Competent Authorities. Again, the implementation of the revised MDD may take a while, but as mentioned above the Notified Bodies started executing unannounced audits of device manufacturers and you can bet they will pay attention to the postmarket surveillance plans and clinical follow-up. Not the least because under the joint plan for immediate actions, there will be more attention for recording and reporting of device related adverse events by sponsors, but also by patients and health care professionals. In other words sponsors should ensure adequate adverse event handling in their clinical studies even more than before, and in case of global/ multi-country studies pay attention to the different reporting requirements across the globe.
Conclusion I am sure the above guarantees an interesting year for clinical studies on medical devices: Happy New Year!