EU MEDICAL DEVICE STUDIES IN 2015: A YEAR OF CONTRAST?

contrast_2015Happy New Year!

Indeed the year 2015 did become an interesting one looking at it from an EU medical device study perspective. Especially since some of the events seem to create areas for tension: More transparency on clinical data, but also better data-protection; further digitalisation of clinical study processes including the Informed Consent, but also standards and policies sticking to the traditional way of working to name some. A list of key events you find below.

Clinical data transparency

On January 1 the new EMA policy on publication of clinical data entered into force: similar to the FDA the agency will publish clinical data supporting marketing authorization of medicinal products for human use. On January 8 the NEJM published the suggested policy for U.S. Clinical Trial Results submission to Clinicaltrials.gov, proposing result reporting of all studies registered on clinicaltrials.gov on the primary and secondary outcomes, and all serious and/ or study product related adverse events regardless their marketing approval status. In April the WHO calls for more transparency on the results from clinical studies to ensure that medical safety and efficacy decisions are evidence based. In September the EMA and the WHO agreed to share non-public information on the quality and efficacy of  medicines on the market or under review in the EU, and beginning December the Dutch Central Committee for human research announces the amendment of the on-line submission system and form to include that clinical study results will be disclosed unless the sponsor has well-founded objections.

Although the above events tend to focus on medicinal products, transparency is also a focal point in the Medical Device Directive overhaul, and one of the key objectives of the Eudamed database is to enhance overall transparency as clearly stated in the latest version of the EU council.

Data privacy

As previously blogged, privacy of study subject information typically is well guarded in clinical studies, but with the globalisation of clinical studies and the level of data protection being different across the globe, and journals requiring sharing for raw clinical data-sets (the BMJ policy on data-sharing took effect in July), data protection has become even more important in clinical studies; In June the EU council approved the proposed data protection regulation. In September the EU’s data protection supervisor Buttarelli stressed that

“today’s trends require a fresh approach”,

and on September 8 the US and EU reached agreement on how to deal with EU-US privacy dataflow. December 15, the EU commission agreed to the new dataprotection regulation, the final texts to be adopted at the beginning of this year. Among other changes, it includes a clarified

“right to be forgotten”,

when you no longer want your data to be processed, and there are no legitimate grounds for retaining it, the data will be deleted.

Electronic Informed Consent

The latter and also other matters related to data privacy are addressed via the patient informed consent, where also interesting trends became visible in 2015. The FDA published their draft guidance for the use of the electronic Informed Consent in March, and, closer to home, in August the NHS approved the use of eConsent technology in a clinical study; comparing eConsent with the traditional paper Informed Consent in the UK. Theoretically the use of an eConsent can help to improve the informed consent process allowing for easier access to information, so this can be a great step forward. As of yet, however, the clinical trial standards such as ISO 14155:2011 and the regional Ethics Committees, such as the Dutch Central Committee for human research, typically require a written informed consent:

“Informed consent shall be obtained in writing from the subject and the process shall be documented before any procedure specific to the clinical investigation ….”,

and pending any amendments it is therefore key to properly document any deviations in that respect. Given the time typically required to adjust standards and guidance’s, this may last a while.

Conclusion

In conclusion, there were many interesting events in 2015, but it will be even more interesting to see how some of the above elements will develop in 2016. I will keep you posted via this blog, so stay tuned and do not hesitate contacting me in case of any questions.

ACS newyear 2015

 

 

About Annet Muetstege

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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