On 16-17 September 2013, the Duke Center for Health Informatics (DCHI)
hosted a two-day meeting for high-level strategy discussions pertaining
to the Essential Standards to Enable Learning (ESTEL) initiative of the
Learning Health Community. This was the third face-to-face meeting
focused on the ESTEL initiative, led by the Clinical Data Interchange
Standards Consortium (CDISC). Participants from universities, clinical
research organizations, biopharmaceutical companies, technology
companies, service providers, standards-developing organizations and
related healthcare entities travelled from as far away as the United
Kingdom and California and also included a number of prominent
organizations from Duke's backyard such as North Carolina Health
Information and Communications Alliance, Inc. (NCHICA), SAS,
GlaxoSmithKline and Quintiles. The multi-stakeholder participants, who
share a dedication to collaboratively realizing a national-scale
Learning Health System (LHS), worked together over the two days to build
consensus on a framework for identifying and developing an essential
set of standards to empower stakeholders across the healthcare and
health IT spectra to realize the LHS vision. Collaborative work
included reviewing current learning projects and identifying
standards-related lessons learnable from them; identifying potential
barriers to success and corresponding ways to surmount them; further
developing a scope for the ESTEL initiative; and strategizing around
next steps culminating in concrete actions promising to make meaningful
Stay tuned for our latest blog entries!
On 16-17 September 2013, the Duke Center for Health Informatics (DCHI)
In July 2004, FDA Commissioner Lester M. Crawford, FDA Commissioner
announced the desire of the FDA to receive data in a standard format,
the CDISC SDTM. "The importance of a standard for the exchange of
clinical trial data cannot be overstated," said Dr. Crawford, "FDA
reviewers spend far too much valuable time simply reorganizing large
amounts of data submitted in varying formats. Having the data presented
in a standard structure will improve FDA's ability to evaluate the data
and help speed new discoveries to the public.”
While this was a very welcome message and encouraged many companies to
begin to become more interested in CDISC standards, it hardly produced a
sudden groundswell in the adoption of CDISC data standards among
What Did the CDISC Teams Accomplish during the Recent CDISC INTRAchange in Silver Spring, MD?
The CDISC INTRAchange is an opportunity for CDISC team members to meet and discuss their CDISC-related work, including current and future tasks, and it provides a special opportunity for cross-team meetings to ensure an understanding of how one team’s activities relate to others. Team members are volunteers who dedicate time from their busy schedules to develop CDISC standards for the purpose of achieving the CDISC mission to develop and support global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare. The CDISC teams are essential to the progress of CDISC and to the process of developing consensus-based global standards. All of the CDISC teams met at the INTRAchange during this 3-day period at the end of July and 1 August. To find out more about the specific CDISC Teams and deliverables, please see the CDISC Annual Report 2012.
The event started on the morning of 30 July with the opening plenary by Wayne Kubick, CDISC CTO, who expressed his deep appreciation to the CDISC volunteers for their hard work and essential role in achieving the CDISC mission. He also presented the CDISC Technical Roadmap and updated all attendees. Dr. Ron Fitzmartin of FDA then presented the FDA Standards Strategy. The slides from these presentations can be made available upon request.
I did not attend many sessions at the DIA meeting because, as many attendees, I was busy meeting new people interested in CDISC and reconnecting with many old friends. I did, however, chair one session – on CFAST: Coalition For Accelerating Standards and Therapies and I attended the subsequent session chaired by Dr. Steve Wilson on the FDA Data Standards Strategy. This was a very informative session with three speakers and a ‘commenter’: Dr. Ron Fitzmartin (FDA), Bron Kisler (CDISC), Mitra Rocca (FDA) and Michael Brennan (J&J).
Dr. Fitzmartin spoke of FDASIA, the FDA Safety and Innovation Act. Specifically, Section 1136 allows FDA to require standardized eSubmissions. Also, it reauthorizes the fifth instance of the Prescription Drug User Fee Act (PDUFA V). The schedule for phasing in these eSubmission requirements is specified as 24 or 36 months after publication of the final guidance (time frame depending on the type of submission). Section XII under the PDUFA Goals states the following:
- Clinical Terminology Standards: Using a public process that allows for stakeholder input, FDA shall develop standardized clinical data terminology through open standards organizations (i.e., CDISC)…
Also, FDA is to publish a proposed project plan for stakeholder review and comment by 30 June 2013. Dr. Fitzmartin stated that this TA Standards Project Plan is in Clearance at FDA, along with the eStudy Data Guidance and an eSource Guidance. He provided further specifics around the FDA Path to Required Study Data Standards.
We had the pleasure of meeting with a number of wonderful individuals in Europe in June. The theme from our perspective was CDISC, of course, but there were many threads of conversation that wove together a lovely tapestry of memory from this particular trip and, in turn, we feel was extremely helpful to CDISC.
The trip began in Paris, meeting with Dr. Michel Goldman and Dr. Olivier Arnaud. The topic was around the Juvenile Diabetes Research Foundation, for which Dr. Arnaud is providing scientific expertise in Europe. Dr. Goldman is an amazing individual who leads the Innovative Medicines Initiative. He had expert advice to lend during this meeting for the JDRF in Europe. CDISC has just launched a diabetes therapeutic area standards project and IMI has projects in diabetes, so a relationship is attractive to all of the organizations and the value of having standards for diabetes research is clear. On a recent call of the CFAST Scientific Advisory Committee, one attendee remarked of the data sharing initiative we were discussing: “The data are so much more valuable when they are in a common standard format”.
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.
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
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.
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.
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
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.
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