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May 19, 2014

EudraCT v10 & EU CTR v2.1 available
The EMA announced on 7th May 2014:

“The Agency is pleased to inform you that EudraCT version 10.0 went live yesterday [6 May]. Also, there was an update to EU-CTR version 2.1. In the scope of this release are:
- Automatic assignment of results users based on CTA information
- View results in EudraCT Secure
- Search for Art 45 trials in EU-CTR
- Upload of Art 46 trials to EudraCT Public
- Substance information is collected through the SMS service”
However, EudraCT v10 is not live on EMA’s homepage yet.

FDA guidance explains device post-marketing requirements
The draft guidance clarifies which clinical data FDA expects prior to approval and which can come after.

Earlier this week, the US Food and Drug Administration (FDA) launched the Expedited Access Premarket Approval program (EAP), a new program aimed at getting innovative medical device products to needy patients more quickly by expediting the regulatory review of the products and their manufacturing processes.
But in addition to the guidance document detailing the program, FDA also issued a draft guidance document on which clinical data FDA will expect companies to have available prior to approval, and which data it will be willing to accept after the device has been introduced to the market.

More details online

A Portal to Share Clinical Study Data Online

With Bayer HealthCare joining this portal that originally had been set up by GSK to manage requests by interested parties to access anonymized patient-level data, protocols and clinical study reports, another pharma company has decided to utilize a shared resource rather than developing its own solution. This is not only a further step towards increased transparency while maintaining patient privacy but is also a sign of an encouraging trend with companies moving away from the old model of in-house silo solutions.

More details online

Association Data and Health (Verein Daten und Gesundheit)
Improving Health and the Personal Data Economy by linked National Cooperatives as Citizen owned and Citizen controlled Personal Data Platforms online

Under the leadership of professor Ernst Hafen from the Swiss Federal Institute of Technology (ETH-Z) in Zurich the Association Data and Health is pursuing an innovative approach to EHRs (Electronic patients' Health Records). Organizing EHRs through a cooperative ownership model is a compelling model as patients are not going to be expected to give away their health data to a third-party that may want to generate profit with their data, but patients keep the full control of the data and if revenue is generated - for instance by making large data sets available to pharma companies to conduct in-silico trials - then such revenue stays with the cooperative group. Cooperative members can decide on how to use such revenue, e.g., for further developing services, providing personalized benefits, etc. Reversing the current model of data ownership - from patients giving their data to a 3rd party to patients keeping direct ownership - is a compelling model that has incredible potential and can serve day-to-day operational challenges (think about managing pharmacovigilance data, early access to novel therapies, recalls in case of issues with a product), serve personal health care needs (a patient faces a clinical need while traveling abroad and she can make all her health care data that “I as the patient THINK is RELEVANT”, available to the treating physician). This approach also elegantly addresses concerns by patients that "3rd parties may want to exploit their data" and they loose control of what is done with their data. Putting the patient in the driving seat (decision maker on what and with whom data is exchanged) also solves most of the data privacy and data protection challenges as the patient keeps full control of its data at all times.

More details online
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