Home / Newsletter / Issue / Fourth Quarter 2016

Fourth Quarter 2016

CDISC Leadership

Esteemed CDISC Colleagues:

I write to you this time with mixed emotions –  gratefulness, humility, pride, uncertainty, excitement, hope and others. Many of you have heard that I announced at the CDISC International Interchange that my role at CDISC is changing. I will serve out my eighth, two-year term in the office of President of the CDISC organization as of April 2017. This will mark 20 years (yes, two decades!) since CDISC was founded as a completely volunteer organization and 17 years since its incorporation. I look forward to my new role as Special Advisor to the CDISC Board, and I am sure there will be other exciting activities.

As we reflect on the year and plan for next year, I am extremely proud of all of the work CDISC and our team of volunteers have completed as well as the initiatives identified and groundwork laid that will take us into 2017 and beyond. CDISC strives to be an innovative organization, led by people, enabled by technology, with the overall goal of improving clinical research. CDISC is on the cusp of a major transition as we have new models for how our standards are developed and new processes to enhance quality and ensure contributions from clinical experts keep our content cutting edge and fresh. Our work is driven not just by regulated research, but also basic science and translational research. We have grown from an entirely volunteer, virtual organization to one that has a robust infrastructure to ensure that the thousands of hours provided by volunteers are utilized as effectively as possible. 

Featured Articles

The 2016 CDISC International Interchange in Bethesda, MD in September focused on implementation and governance, and without a doubt, conformance to the CDISC standards to meet FDA and PMDA requirements. In the closing plenary session Dr. Ron Fitzmartin, Senior Advisor, Office of Strategic Programs, CDER, FDA reminded us of FDA’s 17 December 2016 deadline, and pointed implementers to the FDA’s Data Standards Catalog, Technical Conformance Guide, and other helpful information on the FDA’s Study Data Standards web page. Likewise, Dr. Yuki Ando from PMDA (Japan) described their requirement, which went into effect in October. Dr. Fitzmartin also related FDA’s current metrics on the level of standardization in 2016 submissions showing that 75% of all NDAs and 88% of all new NDAs are already using CDISC standards. This is good news.

Leaders in the fields of biomedical research, regulatory, informatics, patient care and related services gathered at the National Academy of Sciences on 2 August 2016 for a Strategy Session, moderated by Dr. Robert Califf (FDA Commissioner) and me specifically to explore how collaboration, global CDISC standards and related enablers can catalyze more efficient and innovative medical research processes for the benefit of all.  While the adoption of electronic health records continues to increase, there is still a need for interoperability among them and improved alignment with research.

Last quarter’s newsletter featured the article, Enabling Smarter Research to Advance Cancer Breakthroughs, which described CDISC Therapeutic Area (TA) standards for oncology, along with the global, collaborative efforts from volunteers and clinical experts across international regulatory agencies, governmental and non-governmental organizations, biopharmaceutical companies and CROs required to develop these standards. Because many oncology concepts are common to different types of cancers, concepts from one oncology standard (e.g., the Breast Cancer TA) can be reused or adapted to expedite developing additional oncology standards, such as the forthcoming Prostate and Colorectal Cancer TAs. Such reuse also helps improve quality and consistency of the TA standards.

After 20 years in existence, one would think that the answer to the question “What is CDISC?” would be obvious, but even yesterday I was trying to explain this to an audience at the Taipei Medical University.  Many of our Leadership Team Members have had the opportunity to travel in October and November, and much of this involved invitations and travel support to present CDISC to new audiences or to work with new colleagues on projects that would benefit from CDISC.  I have also read with interest the report from the ‘Blue Ribbon Panel’ for the Cancer Moonshot, a draft position statement on data sharing by the Coordinated Research Infrastructures Building Enduring Life-science Services (CORBEL) and recommendations by Patient-Centered Outcomes Research Institute (PCORI) around data sharing and reports on panels at Partnering for Cures. Unfortunately, although data standards are critical to each of these efforts, it seems that the “S” word is either “off limits” or not clearly understood….or both. Our work to communicate about CDISC and the value of standards in research is not done; and, in fact, it becomes more important and urgent each day as increasing amounts of data are generated at an increasingly more rapid pace.

In the second edition of our newly featured Volunteer Spotlight, CDISC would like to thank Éanna Keily for his years of dedication in the field of data standards.

 

Standard Updates

The CDISC Foundational Standards are the basis of the complete suite of harmonized CDISC standards, designed to enhance the quality, efficiency and cost effectiveness of clinical research processes from beginning to end.

 

CDISC, in collaboration with a variety of stakeholders, is developing Therapeutic Area (TA) standards through the Coalition for Accelerating Standards and Therapies (CFAST) initiative. 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 25 indications.

 

In October, an eSource Stakeholders Europe Group was launched, with hosting assistance from Imperial College in London. There were ~ 50 attendees, including two representatives from EMA. The eSource Stakeholders ‘main group’ was launched during the CDISC IntraChange in March 2017.  even sub-groups have been initiated with volunteers and leaders:

SHARE is CDISC’s metadata repository that delivers CDISC standards in machine-readable formats such as XML, RDF and JSON. Access to SHARE is a benefit of CDISC Membership. If you are an employee of a CDISC member organization, and have not taken advantage of the content produced by SHARE, you can do so from the Members Only Area of our web site. 

Membership Update

The CDISC Membership Team would like to say thank you for a wonderful year; it’s all because of your continued support. We are please to announce new membership benefits for 2017, along with updated membership rates, which will help us sustain our growth, keep up with the many innovations in research and healthcare and the needs of our CDISC Community, 

In the News

FDA Binding Guidance: A Pivotal Milestone for CDISC Standards - Barrie Nelson's Closing Thought from the December 2016 edition of Applied Clinical Trials. 

 

Please visit our Newsroom for press releases, articles and additional news stories about CDISC

CDISC Alliances

For our Q4 Newsletter, CDISC is focusing on our European alliances and activities. We partner with a variety of stakeholders worldwide to foster the global adoption of CDISC standards to improve the quality, efficiency and cost effectiveness of clinical research.

CDISC Around the Globe

Dr.  Zibao Zhang who served as the CDISC Chinese Coordinating Committee (C3C) for four years was recently elected to the Asia Pacific Coordinating Committee (AP3C) for a three-year term as Chair. 

In September, E3C held the first of two face-to-face meetings to prepare for the 2017 CDISC Europe Interchange in London, headquarters of the Europe Medicines Agency (EMA). EMA Chief Scientific Medical Officer Dr. Hans-Georg Eichler will deliver the keynote speech at the CDISC Europe Interchange the last week in April. We anticipate additional involvement and updates from EMA, as they continue to increase their support for CDISC standards. Representatives from FDA and PMDA will also be in attendance.

 

French User Network

The CDISC French User Group organized its 2016 second open session in Rennes. Hosted by Biotrial and sponsored by Oracle and Quadratek, the event was a great success with over 65 participants. During the session, we discussed the most recent CDISC initiatives, like CTR.XML, and provided valuable information about older standards, like BRIDG. Sanofi, Clincase and Biotrial delivered excellent presentations on implementing standards, which can be found on the CDISC Portal. (Account registration required). The next session will take place in Paris at Sanofi March 2017.

Hidetoshi Misawa (Pfizer Japan Inc.) chaired a session titled “Impact to NDA Preparation and Approval Review by Initiation of the Submitted Electronic Data” at the 2016 DIA Japan Annual Meeting in November. With the PMDA now accepting the submission and review of electronic study data, differences between PMDA and FDA requirements for electronically submitted study data have arisen, making it necessary for some companies to convert past study data into this electronic submission format.

About 80 people attended the CDISC Japan User group (CJUG)-SDTM Team Monthly Meeting, which took place at the University of Tokyo Faculty of Medical on October 14. Akiba presented “Points to Consider in Public Review for Translations” acknowledging that translation to Japanese is ongoing (based on SDTMIG 3.2 in English) and that the quality of review comments is important. 

CDISC Education Opportunities

Learn CDISC from CDISC! 

It was an exciting year for the CDISC Education Team. View our year-in-review infographic.

Public Courses

Miami, FL (23-27 Jan '17): SDTM, CDASH, ADaM Primer, ADaM Theory and Application

Upcoming Events

Join CDISC at one or more of our annual global events!