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7 Aug 2012

Winner gets the CDISC Innovation Award with Recognition from HHS-ONC, DIA, FDA and CDISC!



At this year’s DIA meeting in Philadelphia on 26 June, CDISC, HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated research. Specifically, research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. In addition, a case study was presented during this session about a research study being conducted currently at Florida Hospital using the Cerner EHR system. Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct research studies.


This challenge will provide FDA, HHS/ONC and CDISC a means to assess the remaining barriers as well as the opportunities to streamline regulated research and increase its capacity throughout the US and the world as EHR adoption is being encouraged and increasing rapidly. Wayne Kubick, Chief Technology Officer (CDISC), spoke first at the DIA session: “CDISC has been doing demonstrations of its Healthcare Link methodology for years now, at HIMSS and at DIA. By adopting the CDISC-IHE profiles used in the CDISC Healthcare Link solution, EHRs can readily implement the standards and profiles to enable the collection of a high quality research dataset that is needed for any regulated research study.”


6 Aug 2012

The CDISC China Coordinating Committee (C3C) was initiated in 2008 when Sandy Lei of J&J came to China and initiated a CDISC group. President, Rebecca Kush, also visited that year and a half-day workshop was held with Lei and Kush as speakers. The first Chair, Simon Wang of Parexel, was elected and a Charter was written. The C3C has since sponsored two Interchanges at Fudan University and more recently initiated a great group that has been validating translations (provided by Absolute Systems Clinical Data Co., Ltd.) and performing translations of the CDISC standards into Chinese. This group is known as CSTAR (CDISC Standards Translation and Review).


6 Aug 2012

“Japan’s Strategy in the Era of Global Development” was the title of
the presentation given at the CDISC Japan Interchange on Thursday, 12
July by Tatsuya Kondo, M.D., Ph.D., Chief Executive, Pharmaceuticals and
Medical Devices Agency (PMDA). This leader of Japan’s Regulatory
organization provided a very informative keynote presentation expressing
appreciation of the value of standards. Many thanks to Dr. Fukushima,
head of the Translational Research Informatics Institute (TRI) in Japan,
for extending the invitation. After his presentation, Dr. Kondo and
two of his staff met with leaders from CDISC Global Operations, TRI,
CDISC Board (Dr. Lastic) and the CDISC Japan Coordinating Committee.


Dr. Kondo stated that “the purpose of Pharmaceutical
Affairs is to improve the public health through regulations to secure
quality, efficacy and safety of pharmaceuticals and medical devices and
take necessary measures to promote R&D, where the reliability must
be verified”. There are three primary roles for PMDA in their quest to
improve the public health and safety of Japan: 1) to reviewing
applications for marketing approval of pharmaceuticals and medical
devices; 2) to conduct safety measures, and 3) to provide relief to
people who have suffered from adverse drug reactions or infectious


27 Jul 2012

CDISC retains IP ownership of all of its standards to ensure that CDISC Standards remain open and free, Even when the standards are translated into other languages, the IP belongs to CDISC.



CDISC standards are created through a consensus-based process that includes many different people who contribute their time and expertise. Thus, the value should serve everyone and the IP be protected. Some standards in other industries were developed in a manner that included proprietary portions such that users were charged royalties. The desire to prevent royalty charges or ownership by any one organization or individual formed the basis for the CDISC IP Policy that is now posted on our website.

23 Jul 2012

Last week CDISC sent a letter to many of our members alerting them to
a potentially damaging and costly patent application which is currently
under review by the United States Patent Office. The text of the letter
is below and was prompted in part by a thread on Linkedin which can be
found here.


The jist of the patent is this: a
company, DataSci, filed a patent application in 2009 that effectively
patents the use of metadata in clinical research. If this patent is
granted there is a real possibility that a fee will be due to the patent
holder for any use of metadata over the internet for every study done
by any BioPharmaceutical company, academic research institution,
government agency – basically ANY clinical research. See the original
email below for more details and links that provide additional


Almost immediately after the email went
out CDISC was contacted by Pharmaceutical, Biotech, Government, CRO and
Technology company representatives company representatives asking how
they could help prevent this patent from being approved. Most have
forwarded the original email to their legal counsel and are looking into
the process to protest this patent. Several of the large Pharma
companies are also discussing how to combine efforts to fight this
patent application.


CDISC appreciates all this effort and
the support shown by our members. We will periodically update this blog
with the status of these efforts.


Original email follows:

23 Jul 2012

This year marks the 10th anniversary of the Japan CDISC Coordinating Committee (J3C), and in celebration of this milestone, CDISC honored their long-standing support at the 2012 Japan Interchange in Tokyo.


Questions and comments are welcome here!

18 Jul 2012

Seoul University

9-10 July 2012

Seoul, South Korea


Greetings from Seoul! Members of our CDISC team have a busy month ahead, with CDISC workshops and an interchange scattered around the Asian continent. We have begun our journey with a trip to Seoul, South Korea, where Dr. Rebecca Kush, CDISC President and CEO, Wayne Kubick, CDISC Chief Technical Officer, Dr. Pierre-Yves Lastic, CDISC E3C Past-Chair and Chair-elect of the CDISC Board of Directors, and Dr. Kiyoteru Takenouchi, CDISC J3C Past-Chair and Board Member, have all given presentations to the K3C and interested parties from the Korean Society of Clinical Development at the CDISC Korea Workshop/Symposium about the importance of using CDISC standards for clinical research. A general overview of the standards and activities was given on the first day, and in-depth training over the standards and how the work together end-to-end was offered the second day.


Questions and comments are welcome here!

9 Jul 2012

As many of you know, changes have been taking place with the Cancer
Biomedical Informatics Grid (caBIG) initiative, a large program of the
U.S. National Cancer Institute (NCI). I am writing this blog with
assurance that the terminology that has been supported for CDISC (and
FDA) through the NCI’s Enterprise Vocabulary Services (EVS) is ‘alive
and well’ and freely available, as usual. I also want to make an effort
to clarify the history and describe what is transpiring with respect to
caBIG as I write.


In March 2011, a report by the NCI’s Board of
Scientific Advisors, entitled ‘Assessment of the Impact of the NCI
CaBIG’, was released. Based upon these findings and recommendations, an
Oversight Sub-Committee was formed to further review the caBIG projects
and make additional recommendations (Members of this Sub-committee are
listed at the end of this blog). Dr. Harold Varmus, the head of NCI,
spoke to the Oversight Sub-committee at its initial meeting in June of
2011. His hope is that this Sub-committee serves as a model for program
reviews and external advisory groups. Participants in the development
of the BSA report (Drs. Stein and Califano) presented their findings to
the Sub-committee after which John Czaikoski presented a response from
the NCI, including actions they had taken to streamline management and
to scale back certain activities that had been identified as having a
less than favorable return with respect to NCI resources spent.


Questions and comments are welcome here!  

9 Jul 2012

For those of you who were unable to attend the DIA 2012 Annual Meeting in Philadelphia at the end of June (or those of you who may have missed this session), there was an excellent set of presentations from FDA representatives. Here is my summary; I would welcome additions and/or comments.


The session was chaired by Dr. Chuck Cooper. Mary Ann Slack spoke first on the topic of CDER Data Standards. She opened: “We cannot improve efficiency or innovate without standards.” CDER is working, with other FDA centers, on end-to-end standards to support a standards-based review environment. They have posted a list of therapeutic area standards that they would like to have developed, to add to the existing standards (which pertain to all research studies); they have also created a ‘notional timeline’ for these. However, she stated clearly that FDA should not drive the standards development; CDISC and the Critical Path Institute, with patient advocacy groups, are working on these, with nine of the therapeutic area standards already in progress. “CDISC, C-Path and FDA collaborate constantly.” (See the CDISC-C-Path Press Release from 23 June 2012 about CFAST).


Questions and comments are welcome here!  

11 Jun 2012

In early May, Bron Kisler (CDISC VP, Strategic Initiatives) and I
spent 5 days (Saturday through Wednesday) at JIC and ISO meetings in
Vancouver, Canada---okay, there are far worse places to spend a weekend
working, and the food there was wonderful, especially since the locals
were talking us to their favorite places. Most importantly, there were
important goals to accomplish for CDISC: 1) to enhance the governance
of the JIC and 2) to get BRIDG through the entire process to become an
ISO/CEN standard. I will provide a bit more detail on each of these,
but suffice it to say that it was a productive week and we are indebted
to many wonderful CDISC friends from around the globe.


The Joint Initiative Council (JIC) began as a group of
3 SDOs, i.e. Standards Developing Organizations, namely ISO, CEN and
HL7. They added CDISC (after a 6 month probation period) when we proved
to be 'good citizens' working with the other three, particularly in
areas that relate to clinical research. Two more SDOs were then
included-GS 1 and IHTSDO. After leadership from HL7 and CEN, CDISC was
asked to Chair the JIC, and Bron has filled this role for over a year