Home / CDISC Blog


24 Jul 2013

During my time abroad I was able to combine my most recent
coursework—Western European Politics—with everything I learned about
medical research standards on the trip. Specifically, in meetings with
CDISC in both France and the U.K., I noticed similarities and
differences between approaches to standards and markets. Regardless, as
the majority of populations in countries become older, it is
increasingly more difficult to maintain a prosperous welfare state. A
welfare state is generally described as a country that provides
assistance for citizens in need to buffer them from the negative
consequences of age, unemployment, poverty and illness. In order to
preserve the welfare state to which many citizens have become
accustomed, it is imperative that European countries use information
more efficiently; standards can play a key role, in this respect, in the
area of medical research information.


As the populations in European countries age and
governments must become increasingly sensitive to this, the need for
standards in the European market will be imperative. Standards not only
provide a way to get an accurate representation of the make-up of some
of the most historically homogenized cultures, but they open up a broad
market for researching and developing data and metadata to more
appropriately serve the aging demographic of people in these countries.
They can also help to address increasing diversity; in other words, to
add complexity to the situation, the movement of individuals from
country to country also affects the demographics of the population
within and across European countries.

19 Jun 2013


The Bay Area CDISC User Network met on 23 May, thanks to
Formedix for sponsoring a venue and John Brega (founder and leader of
this User Network) for organizing the excellent turnout of CDISC
supporters and interested parties from northern California. There were
nearly 100 attendees in person and over 50 on the teleconference at this
event, which followed a Formedix breakfast meeting targeted to
management. The venue was the South San Francisco Conference Center,
which is an award-winning building (for being green) that is
conveniently located within a few miles of the San Francisco airport and
numerous biotechnology companies that have sprung up over the years
near Genentech.


The morning program was quite interesting to me. I
heard Mark Wheeldon speak about his 13-year history and experience with
CDISC standards, and David Borbas of Jazz Pharmaceuticals gave a
business case for management on the use of CDISC and Define tools such
as those that Formedix offers. (I spoke about the CDISC strategy and
technical roadmap). We (CDISC Communications) featured a Formedix
success story a few months ago and will be featuring the Jazz story from
Mr. Borbas in the near future. The slides from all of these
presentations are in the CDISC User Network portal, posted by John
Brega. These are examples of how CDISC User Networks can share relevant
interesting information among anyone interested and make it available
around the globe.

19 Jun 2013

The CDISC User Networks are volunteer-initiated and volunteer-led. The CDISC Bay Area User Network was the first among the current ~ 20 of such networks, having been formed over a decade ago by John Brega. I had the privilege of attending their most recent meeting, which attracted close to 100 attendees in person and another 50+ via phone. I will write separately with a report on additional details from this meeting, which was kindly sponsored by Formedix.


Now, for this blog, I want to focus on the CDISC User Networks in general, since there has been much interest and discussion on the topic this year among CDISC stakeholders, Operations staff and, in particular, the European CDISC Coordinating Committee (E3C). It seems there are opportunities with respect to the User Networks that we could better capture for the benefit of all our CDISC supporters, and there is related interest from our stakeholders in reaping the fruits of these opportunities. For this reason, CDISC has committed to reach out to the leadership of each of the User Networks to see how we could further support their efforts and how we can do a better job of listening to the valuable input that they offer to CDISC.

14 May 2013

Attending the CDISC European Interchange this year was a unique and
very successful experience. Many attendees declared that this event was
one of the best CDISC European Interchanges that they have attended
throughout the past 10 years. CDISC celebrated the anniversary of the
10th European Interchange this year in Bad Nauheim, Germany.


We had a great exhibition area in which our
exhibitors, presenters and attendees met and communicated about recent
accomplishments, including tools and service providers that support
CDISC standards.



the power of our volunteers, CDISC has developed additional standards
in the past 4 years including therapeutic area standards. We have been
listening to your input on how we can provide additional value to CDISC
stakeholders. We enhanced collaboration and education and are providing a
Protocol Representation Tool and others are coming. Patients are
waiting for therapies and their time is precious! We need to make sure
that they understand the value of data standards”, Dr. Kush, President
and CEO of CDISC stated at the opening session of the CDISC European
Interchange in April in Germany. Dr. Kush also mentioned that CDISC
standards are cited in the Structured Data Capture (SDC) Initiative of
the U.S. Health and Human Services Office of the National Coordinator of
Health IT, which offers incentives for meaningful use of electronic
health records. And, CDISC has endorsed the movement of the Learning
Health System (LHS) and is now leading the Essential Standards to Enable
Learning (ESTEL) Initiative while participating in Europe in the IMI
EHR4CR project. Communication is key, she stated at the end of her
State of the CDISC Union presentation.


14 May 2013


Each year for the past 10 years, the European CDISC
Coordinating Committee (E3C) has organized a CDISC Interchange. This
year’s was touted as the best Interchange held in the last 5 years by
many long-time attendees, and was highly regarded by those who have not
had the opportunity to attend the earlier Interchanges. The success can
be attributed to a program of interest to everyone, excellent keynote
speakers and panel discussions that allowed the opportunity for all to
participate. The venue should also be noted – many thanks to Dominik
Ruisinger, who selected a comfortable hotel with a large conference area
in an absolutely lovely area in Bad Nauheim, Germany, near Frankfurt.
Spring was in the air and the trees and flowers were blooming in the
park that surrounded this hotel. When I arrived in Frankfurt and was en
route to the hotel, I was told by one of the locals that “Bad” in front
of a town name in Germany means you should go there to relax. I
commented that perhaps I could relax after our meetings with the E3C,
the CDISC Advisory Council and the Interchange, and how I wish I had
taken a day of vacation at the end of the week to do just that!


The atmosphere at the Interchange was anything but what I would call
relaxing. It was stimulating, enjoyable, educational, informative and
very productive. The attendees and exhibitors had great ideas for CDISC,
from how to better engage the User Networks and additional projects
that the E3C would like to achieve this year, to excellent suggestions
from the CDISC Advisory Council members or their alternates in Europe
on how they could be more effective in assisting and advising CDISC. ,
to the Interchange itself. This blog merely seeks to give one a flavor
of the Interchange – one really had to be there to experience it
appropriately! Mark your calendars for next year: 7-11 April 2014 in
Paris, and don’t forget that we have one in Bethesda, MD on 4-8 November
2013, for which we are currently inviting speakers and calling for

14 May 2013

CDISC Europe Interchange 2013 started with very pleasant weather in
Germany--- the beginning of the spring season! Our attendees enjoyed
the beautiful location in the heart of Bad Nauheim (a lovely small town
north of Frankfurt where Elvis Presley spent two years of his life), and
the special event of the 10th CDISC European Interchange this year!




for previous CDISC Interchanges, the CDISC team spent the prior weekend
on final preparations, making sure to keep the conference running
smoothly and efficiently while providing the best possible support to
our attendees.

14 May 2013


While most of the CDISC staff were in Europe supporting the 2013 Europe Interchange, Sheila Leaman (CDISC Director of Global Relations) and I went to Orlando for the 2013 Partnerships in Clinical Trials conference. At the conference, we met with current CDISC members, handing out “Proud to be a CDISC Member” signs for their booths and engaging with them to gain information on their experiences with CDISC. We also had the opportunity to liaise with potential members to convey the benefits of membership and answer any questions they might have. In all, this was a fantastic experience, and personally having the occasion to meet face to face with those that utilize and support CDISC standards development was tremendously rewarding.


In addition to meeting with current and potential members, we took the time to sit in on one of the discussions, “The Evolution of Clinical Trial Partnerships – Initiative to Forge Innovative Collaborations across the Entire Healthcare Chain.” Speakers during this session were Kathleen Ford of Merck Serono, Ed Pezalla of Aetna, Christine Dingivan of PPD, Kelly Davis of Express Scripts and Dalvir Gill of TransCelerate Biopharma. Sheila and I had had the opportunity to have a very successful discussion with Dr. Gill earlier in the day about the collaboration between CDISC and TransCelerate Biopharma in the area of Therapeutic Area Standards development, and were excited to hear him speak on the panel during this session.

17 Apr 2013


Recent discussions concerning the Learning Health System (LHS), and particularly Essential Standards to Enable Learning (ESTEL), have exposed varying perspectives on the relative overlap standards should have between healthcare and research. There are those who feel research and healthcare have quite different standards requirements while, on the other end of the spectrum, there are those who believe that standards for both research and healthcare should be exactly the same. Of course, there are still others who will indicate that it depends on the type of standards being referenced. Sixteen years after Bron Kisler and I developed a slide with two intersecting circles – one for healthcare and one for research – I am even more convinced that this is a Venn situation.


From Wikipedia: A Venn diagram or set diagram is a diagram that shows all possible logical relations between a finite collection of sets (aggregation of things). Venn diagrams were conceived around 1880 by John Venn. They are used to teach elementary set theory, as well as illustrate simple set relationships in probability, logic, statistics, linguistics and computer science (see logical connectives).


Below is the slide I am referencing, which was our vision in 1997 as to how to streamline research.



12 Mar 2013

The CDISC vision is informing patient care and safety through higher quality medical research. This might be viewed as the CDISC contribution to a ‘Learning Health System’. When CDISC was founded in 1997, there was (and still is) a clear desire to streamline the means by which research information can be gleaned from clinical care to ultimately provide increasingly better knowledge to benefit patients. This desire was communicated as two key goals: 1) to make it easier for clinicians to do research, and 2) to improve data quality and patient safety.


You have heard this before, but we are all patients; and, those of us who have been working with CDISC for the past 1.5 decades are that much older and feeling an increased urgency towards accelerating the ‘research-healthcare learning cycle’. The 17 years that it is said to take for research findings to make their way back into clinical care decisions is simply too long, and we all know that healthcare costs continue to skyrocket without the resultant improvement in speed of innovation nor quality of care.

11 Mar 2013

Great Moments at the CDISC Asia-Pacific Interchange The Inaugural CDISC Asia-Pacific Interchange (CAPI), held in Singapore 18-22 February, was an incredibly successful event, drawing over 100 leaders from Thailand, India, Japan, Singapore, South Korea, China, and Australia, as well as the USA, France, the UK and Belgium. While conference content included traditional subjects, such as presentations on case studies using and implementing the CDISC standards, there were also heavily attended and engaging subjects specialized for the Asia-Pacific region. Specifically, there were updates on the status of clinical research and usage of CDISC standards around the Asia-Pacific region, region-specific presentations on the use of EHRs for research and a highly interesting session on therapeutic area standards, which included a presentation on the development of standards for traditional Chinese medicine (TCM).


There were many encouraging moments at CAPI, but one of the greatest highlights, to me, was the number of CDISC Board members that not only attended the bi-annual face-to-face Board of Directors meeting (held in Asia for the first time), but spent the rest of the week thoroughly engaged in the Interchange presentations and associated discussions. Eight CDISC Board members even took time out of their very hectic schedules to participate in a panel discussion and Q&A session for Interchange attendees.