CDISC Leadership

Here we are at the end of the third quarter. Is anyone asking themselves “Where has the year gone?” It’s evident that the nimble and mighty staff team at CDISC and our dedicated volunteers have been hard at work developing standards and innovating to ensure our standards remain relevant now and into the future.  As clinical research evolves, CDISC is evolving too and you will read about our various projects, along with the 2019 – 2022 Strategic Plan, which undergirds them.

Featured Articles

CDISC is excited to launch the CDISC Library Data Standards Browser at the US Interchange 16 - 17 October in San Diego. The Browser is a benefit of membership available at no additional cost to all CDISC members. We believe our members will find the browser quite useful, and we look forward to your feedback on this newest membership benefit. The CDISC Library data standards browser allows wider stakeholder access via an intuitive, user friendly interface to the same normative metadata formerly found in a Rest API. Users can now simply select the CDISC standard (e.g., CDASH, SDTM, ADaM, etc.) they wish to review in more detail. Traversing the standards includes access to all associated metadata (i.e., models, classes, domains, variables, controlled terminology, etc.). The data standards browser also provides explicit relationships across products, such as identifying the model to an implementation guide or controlled terminology association(s). This content can be further filtered at its result level (e.g., by keywords), which makes the data standards browser an ideal querying mechanism. Additional key features include search capabilities via elasticsearch and export functionality (e.g., CSV, XLSX).

Are you an open source developer?

If so, CDISC would like you to gain access to CDISC Library to create tools and applications that foster greater innovation and can be leveraged by industry.

The CDISC 360 project, introduced in the Q1 Newsletter, launched the week of 8 April 2019 with a Kick-off meeting and a Workstreams Briefing meeting for over 45 participants. CDISC 360 will run for 18 months and the first 10 agile sprints (3-4 weeks each) will cover the remainder of 2019.

Tremendous Interest in Participating

As of today, more than 60 talented individuals from 26 CDISC member companies are contributing active expertise to this important project. They are a global group from Asia, Europe, and North America. Their companies cover the spectrum we hoped, including pharmaceuticals, biotechs, CROs, technology firms, and solutions providers.

A series of collaboration tools have been provided to support workstream teams as members work remotely worldwide. These tools include shared environments for document content (Wiki), issue tracking (Jira), concept mapping (Cmap Cloud), instant messaging (Slack), and metadata management (CDISC Library). In addition, Microsoft, as a project participant, is providing its Azure platform to further support collaboration, including but not limited to support for data storage and script execution in multiple scripting languages as the project team executes the use cases.

CDISC has been working diligently on strategy and innovation, thanks to funding from The Leona M. and Harry B. Helmsley Charitable Trust, which invests in critical projects:  the development of new data standards for type 1 diabetes (T1D) and Crohn’s disease (CD) research as well as a new set of innovative activities designed to help us move significantly forward in developing the types of standards that can be utilized by non-standards experts. Because of Helmsley’s support, CDISC standards will be opened up as never before to academic researchers, the open source community, and others who can benefit from data standardization and interoperability, but also face a high threshold to implementation of CDISC.

Mike Ward

Consultant Data Standards - Clinical Information and Process Automation

Eli Lilly and Company

Mike serve as volunteer lead for the CDASH Team.

 

How long have you been volunteering at CDISC?

I first started actively volunteering on the CDASH team early Q1 2011.  At that time, CDASH v1.1 has just been published and the CDASH team was developing a User Guide, its first library of example CRFs, and an ODM.xml representation of CDASH v1.1.

What encouraged you to volunteer your time and expertise with CDISC?

I cannot clearly remember if I volunteered of my own free will or was drafted into service by Shannon Labout. I attended my first CDASH training at the CDISC 2010 Interchange, which Shannon had taught, and I made the mistake of asking lots of questions during class.

At that time at Lilly, we were rapidly developing our data collection standards library and storing it as metadata within an ODM.xml based application.  Working with the CDASH team on those initial projects gave me the exposure I needed to better understand CDASH, SDTM, Controlled Terminology and ODM.  Not only was I able to promulgate that learning here at Lilly, but I was also able to influence the industry with many of our internal data collection best practices.

Transform, Expand, Support, Include, Engage are the five goals of CDISC’s 2019 – 2022 Strategic Plan, which we released in July. Flowing from the insights of the Blue Ribbon Commission, the Strategic Plan guides CDISC and our global community to evolve so that data standardization facilitates more meaningful and efficient research that has greater impact on global health.

Standards Updates

CDISC Foundational Standards are the basis of a complete suite of data standards, enhancing the quality, efficiency and cost effectiveness of clinical research processes from beginning to end. Foundational Standards focus on the core principles for defining data standards and include models, domains and specifications for data representation.

Therapeutic Area (TA) Standards extend existing CDISC standard metadata to include disease-specific metadata, examples and guidance on implementing standards for a variety of uses, including global regulatory submissions. To date, CDISC has developed TA standards for over 30 indications.

CDISC invites interested stakeholders to submit comments on the following standards available for public review. We rely on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all. Current Public Reviews include:

Controlled Terminology Package 40 Comments due: 18 Oct 2019

Therapeutic Area User Guide for Type 1 Diabetes - Pediatrics and Devices  Comments due: 11 Nov 2019

Membership Update

As part of membership benefits, CDISC Members receive 20% (Gold level) and 40% (Platinum level) discounts off all CDISC Training Courses and CDISC Interchanges. Training credits do not carry over or accumulate if unused by the next renewal date.  At the start of the next renewal date, they are renewed in full.

Register for the 14-18 October US Interchange in San Diego and make use of your membership discounts.

CDISC Around the Globe

CDISC held our annual Japan Interchange in Tokyo in July at the Ito International Research Center on the University of Tokyo campus. The Academic Workshop was held on 10 July, and the Main Conference on 11 – 12 July. The conference program received a lot of praise this year, and was packed with content, needing to be expanded to two tracks for the first time. Speakers included Dr. Mihoko Okada, President of the Institute of Health Data Infrastructure for All, who gave the keynote address, six speakers from the PMDA, FDA and EMA, and presenters from around Japan and the rest of the world. The Exhibition Area and Networking Event were bustling with activity during both days of the conference, and included the first poster session to be held at our events in Japan. The CDISC booth was highly frequented, and many of the attendees took pictures in front of the new CDISC backdrop, often catching our President and CEO David R. Bobbitt for a quick photo!

The 2019 CDISC China Interchange was held in Beijing 19 – 20 September. This year’s conference saw the highest attendance numbers for its Main Conference yet, with 200 total attendees across both the conference and education courses. The two-track conference at times was filled to overflowing, and attendees gained insights on hot topics like Real World Data, AI, CDISC 360 and CDISC Library, End-to-End Automation, eSubmission and more. The Keynote presentation, “The Evolving Drug Development Ecosystem in China” was provided by Dr. Zhengqing Li, Vice President and General Manager of MSD China R&D and CDISC Board member. Speakers from the FDA and PMDA provided presentations on data standards, nonclinical study data and SEND, safety review, eSubmission and requirements.

CDISC and the Chinese CDISC Coordinating Committee (C3C) are working closely to get the Chinese translations of six CDISC standards ready for Public Review.

The 2020 CDISC European Interchange will be held in Berlin, Germany returning to the Titanic Chausse Hotel, the same great location from 2018. The conference takes place 1— 2 April, earlier than other years.

Call for abstracts is already open; submission deadline is 29 November 2019. We encourage you to share your expertise by submitting an abstract.

The CJUG SDTM team held our regular monthly meeting on 9th August at Astellas Pharma. Excellent presentations were accompanied by active discussions. We held breakout sessions for attendees to participate in team activities.

Our next meeting took place 6 September at Oracle. Guest presentations included such titles as “Clinical Data – Where Are We Now” and “Challenges of CDISC Metadata Repository Implementation”, followed by in-depth discussions among sub-teams.

After the meeting, we enjoyed attending a baseball game.

The CDISC UK Network held an excellent and informative event at the Oracle office in London on 3 September. We received an update on the E3C changes and the EU Interchange from Joerg Dillert and listened to sessions from Peter Van Reusel on the findings of the Blue Ribbon Commission and the plans for the CDISC 360 project. We also heard a view from academia with a presentation from Kalynn Kennon from IDDO on a novel SDTM implementation to aid data sharing.

    After the success of the last event, which took place in Paris in June, the CDISC French User Group (GUF) is now heading toward our second meeting of the year. The meeting will be hosted for the second time by Biotrial in Rennes on 3 October 2019.

    Thanks to our sponsors AB-cube, Anju Software and Quadratek, this conference is free to attend. We are looking to hearing the insights from the many speakers.

    Here is the agenda:

    The Bay Area CDISC User Network hopes to schedule a Q3 meeting for late October/early November. Key topics will include the FDA’s implementation of the new Technical Rejection Criteria and the FDA’s and Industry’s implementation of con med coding in the WHODrug B3 format, which is now effectively a requirement.  We plan to have FDA participation for both topics.

      Education and Training

      Join us for our upcoming webinars, which address industry hot topics, best practices and challenges around implementing the standards, allowing attendees to learn from the CDISC community of experts.

      Of particular interest is the webinar Why Data Sharing and Data Standardization Matter an exclusive conversation with Vivli Executive Director Dr. Rebecca Li, UCSF professor and Vivli Co-Founder Dr. Ida Sim, and CDISC President and CEO David R. Bobbitt.

      CDISC is pleased to announce the release of a free learning module for our Therapeutic Area User Guide for HIV. The learning module provides an understanding of HIV Treatment and Prevention, how to read and interpret concept maps and how to develop data structures for HIV indication data using CDISC standards.

      Greater Clarity Starts with CDISC Education

      Our  Public Training courses provide expert-led training for individuals of all experience levels. Courses range from 1/2-2 days. Participants can choose to register for one or all courses offered.

      Upcoming Events

      2019 US Interchange - San Diego, CA

      14 - 18 October, 2019

      Join Us in Sunny San Diego!

      PHUSE and the FDA are excited to announce the PHUSE/FDA Data Science Innovation Challenge, where data scientists, members of the public, colleges, companies and professional societies compete to help shape the future of healthcare.

      The event sponsors, Lilliam Rosario (OCS Director, FDA) and Stephen Bamford (PHUSE Founder and Chairman of the Board), are inviting you to join this challenge, to work on prototypes and to present your proof-of-concepts or solutions at the PHUSE US Connect 2020 in Florida, Orlando during March 2020.

      CDISC partners with a variety of organizations to further the global adoption of standards. We will be presenting at various conferences worldwide this fall. Join us!

      Visit Us at Booth #704
      29 Sep 2019 to 2 Oct 2019
      Baltimore, Maryland, United States

      In the News

      Austin, TX – 18 September 2019 – CDISC is pleased to announce the first release of a global Therapeutic Area Standard using Traditional Chinese Medicine. Specifically, the standard describes how to use CDISC standards to represent data pertaining to coronary artery disease for the treatment of angina. Released in the form of a User Guide for data managers, statisticians, programmers and study managers, the standard is freely available on the CDISC website.

      Austin, TX – 28 Aug 2019 – CDISC congratulates Bron Kisler, a founder of CDISC and long-time executive, on being elected Chair of the ISO/TC 215 Genomics Sub-Committee. Kisler was unanimously elected by 30 member countries from across Asia, Australia, Europe and the Americas. This newly launched Sub-Committee (SC) will standardize genomics data globally across ISO-member nations and beyond. The scope of the Genomics SC is “Standardization of computable data, information, and knowledge, including their representation and metadata, for the application of omics, including but not limited to genomics, transcriptomics and proteomics, to support human health and clinical research.”

      MANHATTAN BEACH, CA and AUSTIN, TX – 27 Aug 2019 The Pancreatic Cancer Action Network (PanCAN), the leading pancreatic cancer patient advocacy organization, and CDISC, the global nonprofit dedicated to developing and advancing clinical research data standards of the highest quality, announced today a collaboration to establish the first-ever data standards specifically for pancreatic cancer.