CDISC Blog

CDISC in Japan

November 2011, Rebecca D. Kush, PhD, President and CEO, CDISC

Japan has a long established reputation for quality, based upon processes that build quality in from the beginning. The value of CDISC increases dramatically as it is implemented upstream in the medical research process---in developing case report forms or protocols. I was honored and pleased to have been invited to speak at the 3rd Global Quality Assurance Conference held in November 2011 in Kyoto (which was even more remarkable than usual, during the peak of the fall color changes). Yoshio Tsukada of GSK and the leader of the Japan CDISC Coordinating Committee (J3C) organized a pre-conference workshop entitled “CDISC Makes You Happy”. The crowd numbered ~ 250 in the splendid Kyoto Conference Center (see photos); they gathered to hear the 6 speakers of this session on Sunday afternoon, 13 November.

The main messages I took home from this session are shared here with you:

Mr. Yoshio Tsukada, as the Chair, introduced the session and speakers. He presented CDISC as one of the significant key players for efficiency for ALL stakeholders. There is a need for a simple flow in clinical research, from collection through reporting, which CDISC facilitates.

CDISC Activities in Japan – November 2011, R. D. Kush

At 23:00 Japan time on Thursday, 10 November, after traveling for ~ 22 hours (starting from JFK in New York City) I arrived at the Seahawk Hilton in Fukuoka, Kyushu. I made an effort to get some sleep that night since my presentation was scheduled for 17:00 on Friday, 11 November at Kyushu University. It was an interesting feeling to return to Kyushu ~ 25 years after I had given a presentation there on an entirely different subject when I was living and working in Tokyo…before CDISC was even a dream. This area has experienced significant growth, yet it is still beautiful with its seaside location and nearby mountains and pine trees. The next morning I realized I was right on the water, at the tip of Japan and only about an hour from Korea by boat.

Dr. Ken Toyoda had been inviting me to speak in Kyushu for several years now, so the Kyoto QA Conference (see previous blog) offered an opportunity to do so on the prior Friday. Approximately 40 doctors, dentists and researchers, most in white coats, were in attendance for the presentation on CDISC. Dr. Toyoda leads the ISO TC215 group in Japan and I know him from ISO meetings; he also launched a Clinical Research support organization/CRO and works with the Center for Clinical and Translational Research at Kyushu University. He and Junji Kishimoto, who created an English business card especially for my visit, provided translations and comments at various points throughout the lecture. I could not resist but begin my presentation with a slide showing only 11-11-11. That was the current date and the only day of this year when metadata was not essential to interpret the date!

Computational Science Symposium, Silver Spring, MD

March 19-20, 2012

I like to compare improving efficiency in clinical trials to eating an elephant; where do you start? With an industry that spans hundreds of companies, thousands of people all over the world, and a process that must be rigorously controlled, at some point you need to make a decision to start somewhere and build from there. This is the thought behind the FDA/PhUSE Annual Computational Science Symposium (CSS). FDA and PhUSE have worked together to define the first pieces of the elephant by defining six working groups. The topics of these working groups include: data validation, reducing risk with site selection, integrating data, converting data (CDISC SDTM), implementation of CDISC models, developing standard analyses, and non-clinical data standards implementation (CDISC SEND). Over time these working groups will evolve and the topics and issues of greatest interest will rise to the top. http://www.phuse.eu/Working-Groups.aspx

But let’s not get ahead of ourselves; these core topics are already challenging by themselves. How are we, as an industry, going to make significant advancements on this idea? Powerpoint, while good at presenting an idea, is not ideal for collaboration. The model of presenting and listening needs to evolve; we need to sit down, roll up our sleeves, dive into the details and begin putting a plan in place on how to move forward. It is understood that solutions are not going to be miraculously discovered in a two-day meeting. Working groups initialized at the CSS 2012 will continue throughout the year documenting progress on the PhUSE Wiki. CSS 2013 will start with a presentation of the work that had been completed and a kick off of next year’s goals.

EHR Roundtable Meeting

Philadelphia, Pennsylvania

29 November 2011

At the end of November, I had the opportunity to sit in on an Electronic Health Record (EHR) Roundtable discussion, which was organized by Tufts Center for Drug Development, CDISC and HL7 and took place at the GlaxoSmithKline complex in central Philadelphia, PA. There were exciting updates about the status of EHRs globally, with primary topics of discussion revolving around the expansion of EHR usage to assist in promoting safety and to enable research.

EHRs are gradually being adopted worldwide. Already, nations like Singapore have adopted nationwide EHR systems. One of the greatest hurdles to the adoption of EHRs for research has been regulatory ‘approval.’ Acceptance by regulatory entities of EHRs is critical for expanded adoption, but at the present moment there continue to be concerns voiced and misperceptions communicated, which encourages the continued practice of inefficient re-entry of data from paper.

Collaboration in Medical Research & Healthcare Industries Supports Faster & Safer Drug Development

Last year Critical Path Institute (C-Path) and Clinical Data Interchange Standards Consortium (CDISC) launched a landmark joint project to develop a successful Alzheimer’s Disease (AD) data standard and research database. Data from eleven AD clinical trials from seven of C-Path’s Coalition Against Major Diseases (CAMD) member organizations (who are also CDISC members), was converted into the CDISC SDTM standard. During the process, new formats were added to SDTM to create a resulting new therapeutic area specific standards package, the CDISC AD standard. The data were then ready to be aggregated, and the result was a database incorporating detailed data from over 4,100 individuals afflicted with AD, a groundbreaking achievement that will assist researchers in developing safer and more effective treatments for those suffering with AD.

The collaboration between CDISC, C-Path, government agencies, academia, patient groups and the AD clinical community in developing the CDISC AD standard is a valuable model of how a successful consortium can support faster and safer drug development. In much the same way that CDISC has collaborated with C-Path to develop Alzheimer’s data standards, CDISC and the Innovative Medicines Initiative (IMI) have recently signed a Memorandum of Understanding (MOU), agreeing to collaborate for the shared purpose of accelerating the development of new therapies for patients worldwide.

IMI, the largest public-private partnership in Europe, supports further innovation in healthcare through the formulation of partnerships between industrial and academic experts to aid in the creation of a more cooperative environment for R&D, encouraging the development of safer and more effective drugs for patients. IMI seeks to address certain inadequacies in R&D causing delay in the drug development pipeline through four research priorities: 1) predicting safety, 2) predicting efficacy, 3) knowledge management and 4) education and training. With knowledge management in particular, IMI seeks to more effectively utilize data to determine safety and success.