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Life Science News - EMA data transparency regulation upheld in court

Excerpt from Outsourcing-pharma.com's Article "EMA data transparency regulation upheld in ‘landmark rulings’" by Melissa Fassbender | March 06, 2018

 

(photo credit: outsourcing-pharma.com)

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The EMA’s decision to release clinical trial documents requested in accordance with its Transparency Regulation has been upheld in court after companies filed to suspend the release in 2016.

According to the EMA, this is the first time that the Court of Justice of the EU has “had the opportunity to pronounce itself on the application of the Transparency Regulation to documents held by EMA.”

The court rejected claims by Pari Pharma, PTC Therapeutics, and MSD Animal Health Innovation and Intervet, explaining the companies failed to prove the release of the contested documents would undermine commercial interests.”

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d-Wise's Insight on Outsourcing-pharma.com's Article

David Bobbitt, CEO of CDISC, provided interesting insights on his recent article regarding data trends in clinical research and d-wise is very encouraged by Mr. Bobbitt's efforts to reshape CDISC. We believe that personal devices and more broadly real world data have the opportunity to positively impact if not radically reshape clinical trials. We agree with Mr. Bobbitt that interoperable standards are needed for the effective use of personal devices and their data within clinical research. This need (and opportunity) presents CDISC with a unique opportunity to demonstrate it is indeed a changed organization and understand what is needed to truly make standards interoperable. How? The development of CDISC standards has traditionally been very siloed both within clinical trials and across other data streams. This has often resulted in bespoke products that don't integrate seamlessly or don't integrate with external data sources. Establishing standards for personal devices provides CDISC with an opportunity to do think in a 'new' and 'innovative' way by leveraging new approaches and technologies for modeling and representing clinical information, and utilizing the expertise of stakeholders outside of the traditional CDISC users.

A Clinical Trials Transformation Initiative (CTTI) article released in June 2017 said the following about standards development for personal devices: "In order to promote the scientific, technical, and medical benefits of novel endpoints, shorten development time, and increase the quality and usefulness of mobile technology-derived assessments, CTTI recommends establishing industry-wide standards related to 1) terminology, 2) the collection and reporting of data captured by mobile devices, and 3) transparency requirements for the algorithms used to convert the data into physiologically and medically useful endpoints. CTTI recommends that stakeholders, including mobile technology companies and sponsors who may produce competing tools or develop competing therapies, collaborate in a pre-competitive space to set these standards."

We hope CDISC takes this opportunity to continue demonstrating "it's a new day at CDISC" and lead the industry towards the innovation needed to make these trends happen.
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