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2015 Europe Interchange Success – CDISC Standards Save Lives

The 2015 CDISC Europe Interchange was by far the most successful event in the history of the CDISC Europe Interchanges. The Interchange was held in Basel, Switzerland, a beautiful city situated on the border of Switzerland, with sides touching both France and Germany. Basel is well known for its Romanesque, Renaissance and contemporary architecture, dotted with amazing small shops offering Swiss chocolate! 322 people attended this event, marking the highest attendance number compared to all prior CDISC Europe Interchanges. The conference was full of engaging presentations, including those from representatives from healthcare and regulatory entities that came to attend this event from around the world including the Japan PMDA, U.S. FDA, and EMA. Our Education courses were a great success, and attendance for the FDA Workshop that was offered on 04 May exceeded the maximum limit for registration! The networking event on 05 May was held on a boat that traveled the Rhine between the borders of Germany, France and Switzerland! Attendees were indulged with a fine Swiss dinner, amazing drinks and delicious desserts. An excellent time was had by all, and I am certain that this Interchange will not soon be forgotten.

CDISC in the Year 2020

What’s next on the way to 2020?

 

At the closing session of the CDISC European Interchange in Basel, Switzerland, the panelists from the FDA, EMA, PMDA, and CDISC were asked by facilitator Peter van Reusel for their vision and goals for CDISC as we approach 2020. What will CDISC look like in 2020?

 

Below is a list of goals and visions discussed:.

  • How can CDISC better help patients?  Communicate to patients and their families how CDISC standards can improve medical care for patients.  Increase the level of data sharing.  Patients will have access to their data as well as information from other patients to help them make informed decisions about their medical care.
  • CDISC SHARE will help us develop, maintain and increase accessibility to harmonized standards starting with the protocol and carrying all the way through tabulation, analysis, reporting/submission and post marketing surveillance.

 

CDISC Asthma Therapeutic Area User Guide: AstraZeneca’s Implementation Project

The CDISC Therapeutic Area User Guide (TAUG) for Asthma was the first standard developed under the collaborative CFAST (Coalition for Accelerating Standards and Therapies) Initiative. The CFAST process has incorporated new approaches to streamline the CDISC standards development, especially for specific Therapeutic Areas (TAs). The TA standards augment the CDISC Foundational Standards that are common across all TAs. Since the publication of the Asthma TAUG in 2013, CFAST teams have published 9 CDISC TA standards, and there are 11 projects currently ongoing through the CFAST process.

 

After 2 years of developing TA standards under the CFAST program, it was indeed welcome to hear of AstraZeneca’s positive experience in implementing this CDISC Asthma standard into their systems. 

CDISC Europe Interchange - Standards Development Workshop

CDISC held the second face-to-face Standards Development Workshop on 7 May 2015 after the European Interchange in Basel, Switzerland. The goal of this workshop was to help projects, started in response to urgent global health needs, move forward in the development process. Teams had the opportunity to come together and have their work reviewed by CDISC standards experts. The five Specialty Area teams that participated in the workshop were Ebola, Malaria, Vaccines, Nutritional Research and Traditional Chinese Medicine (TCM). These teams are at different stages in the standards development process and have various goals and deliverables. Members of these teams live in different countries; in common, however, is their enthusiasm and dedication to creating global standards. This workshop provided a unique opportunity to meet in person and take advantage of the expertise available in Basel for the Interchange.

 

After a brief status presentation by each team, the focus shifted to a hands-on working session. Experts in Controlled Terminology, Metadata Development, Project Management and Standards Development, from the Critical Path Institute and the National Cancer Institute, attended the workshop to resolve issues, provide guidance and answer questions that arose during team discussions. A number of CDISC staff were also available to provide additional resources to assist the teams.

Metadata Repositories and SHARE

During the 2015 CDISC European Interchange I participated (among other things) on the discussion panel for Session 10: Metadata Repositories from the Pharma Perspective.The session was extremely well attended, indicating a lot of interest in the topic area.Speakers from three pharmaceutical sponsors presented on the status of their MDR implementations, followed by a session on SHARE and Research Concepts by Julie Evans of CDISC.Some of the takeaways from the presentations and subsequent panel discussion for this session included:

  • The consensus legacy MDR for most companies to manage their standard metadata still seems to be that old standby, Microsoft Excel.  
  • There’s a great deal of interest in MDRs, but many companies are still trying to figure out what they do, why they’re necessary and how to prioritize an MDR versus other investments.

Urgent Need for Standards in Ebola Research Brings a Global Team Together in Basel

On Thursday 7 May 2015, a small group of people from a wide geographic distribution - ranging from Vietnam to the western United States - met in Basel as a team that will create the formal documentation of data standards for Ebolavirus disease (EVD) research that is needed to make this an official CDISC Therapeutic Area standard.

 

This team, co-led by Maura Kush (PharmaStat) and Shannon Labout (CDISC), and guided by clinical trial expert Laura Merson (Oxford University Clinical Research Unit), will build on the work started in 2014 during which a set of EVD CRFs, developed as a core data set by the World Health Organization (WHO) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) for EVD studies, were annotated by CDISC experts using the SDTM and CDASH standards with the goal of helping ISARIC researchers quickly set up standardized databases during the height of the EVD epidemic, and to support data sharing from their research projects. Those SDTM and CDASH CRF annotations were made publicly available to the EVD researchers through the ISARIC website.

The CDISC Europe Interchange and the Untapped Value of CDISC Licensed Training

What I took away from this year’s CDISC Europe Interchange in Basel, Switzerland is a lesson I have most often gleaned from CDISC Interchanges—a conference where people are seeking to learn more about implementing CDISC standards. Yes, there is networking and exchanging of ideas, but the overarching takeaway is that attendees want to be more in tune with CDISC standards and learn how best to implement them at their organization. Since CDISC’s inception, industry professionals have sought out our proven training courses to learn our standards.


CDISC Standards to Facilitate Ebola Research

The Clinical Data Interchange Standards Consortium (CDISC) has been invited to contribute towards a consensus-based global standard to facilitate data collection, aggregation and analysis of research data related to Ebola research on trials of potential treatments, vaccines and surveillance.   CDISC can provide the global ‘language’ needed to share information gathered through such research studies around the world.

 

The Oxford University Clinical Research Unit (OUCRU), working in London and Vietnam, has expressed interest in using the existing CDISC Foundational Standards for their research, while enhancing these global standards to meet any additional data requirements necessary for Ebola. OUCRU has received funding from Wellcome Trust and collaborates with others such as NIH and Medicins Sans Frontieres (Doctors Without Borders).

Don’t Miss This Special Opportunity to Attend Our New SEND Implementation Course!

This November in Bethesda marks the first time CDISC Education is offering the new Implementation course in the Standard for the Exchange of Non-clinical Data, otherwise known as SEND, at an International Interchange. SEND is a CDISC standard that provides the structures and implementation rules for the submission of data from single- and repeat-dose toxicity studies and carcinogenicity studies, and is built on the Study Data Tabulation Model (SDTM).

What’s in a SHARE Value Level Metadata Library?

What’s in a Value Level Metadata (VLM) Library?

SHARE has the capability to store and publish Value Level Metadata (VLM) content. Currently, the only CDISC standard describing VLM is Define-XML. Define-XML provides the structure for VLM along with some guidelines on when it’s useful, but it does not provide standard VLM content. The Define-XML v2.0 specification states that VLM should be applied when it provides information useful for interpreting study data, and that it need not be applied in all cases. Precisely what and where VLM should be used is determined by study implementers.
 
Since there are no hard and fast rules describing when to use VLM, what should be included in a SHARE library of VLM content? It might be useful to ask, “where is VLM being used today?” Based on input so far, most implementers add VLM where they think the regulatory reviewers might want to see it. Since many organizations are not yet using Define-XML as a machine-readable specification, but are instead creating it to fulfill an FDA submission requirement, implementers often add VLM for only the most very basic and obvious cases.  How should the SHARE VLM content be published so that it would be useful to implementers?  For those that are using VLM as a machine-readable specification, how are you using VLM?
 

A Proposal for Developing a VLM Library in SHARE

In line with current VLM usage, the SHARE team proposes to publish VLM for the most basic and obvious cases first. The VLM will be published as Define-XML v2.0 files and made available for download in eSHARE.

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