CDISC Blog

Notes from Partnerships in Clinical Trials

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.

CDISC Europe Interchange 2013 - Very Pleasant Start

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!

As 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.

A Flavor of the CDISC Europe Interchange

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 abstracts!

The Tenth CDISC European Interchange - An Outstanding Experience

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.

“With 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.

Healthcare and Research: A Venn Situation

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.