Healthcare Link was well-represented at this year's CDISC International Interchange meeting in Chicago. On Day One, the eSource Stakeholders Group Informational Meeting took place. This was an open meeting to help get the word out about the recent FDA Federal Register Notice encouraging "Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data." The meeting attendance reflected the wide mix of stakeholders involved in this effort, including biopharma, academic medical centers, EDC vendors, and CROs. After introductions, Alana St. Clair of CDISC took the group through a general review of the FR Notice to ensure everyone started with the same understanding, then the group engaged in an open discussion about questions, challenges, and progress already made in pursuing an "eSource" project. Trisha Simpson of UCB and Amy Nordo of Duke discussed their respective work on eSource projects for the group, and several challenges awaiting projects in this area were discussed. The attendees agreed that establishing a formal eSource Stakeholders Group was in everyone's best interest, and there is more to come on that front.
The well-attended CFAST Therapeutic Area session was filled with presentations from several different perspectives. The goal for the session was to expose attendees to some of the projects and topics that TA teams are working on and provide as much information as possible about new approaches, tools and available standards.
The session began with Rhonda Facile, CDISC, describing the governance and current status of CFAST TA projects. To date, the CFAST program has published 16 TA User Guides (TAUG) and there are 18 ongoing projects with 6 targeted for completion in 4Q15/1Q16. 7 more projects have been approved by the Steering Committee (TAPSC).
Dr. Mayumi Shikano from the Pharmaceuticals and Medical Devices Agency informed attendees about the PMDA’s plan to create a J-CFAST organization to develop TA standards in Japan and provide input into published and emerging CFAST standards in the US and EU.
Jerry Salyers from Accenture presented on “Data Standards, Considerations & Conventions within TA User Guides” in a style that was both informative and entertaining. Jerry concluded by stating that CFAST has “accelerated standards development and this has resulted in a number of new SDTMIG domains, variables and modeling strategies.” He expected this to remain the trend.
The 2015 International Interchange in Chicago, IL included a talk by the Chief Patient Advocate of Medidata Solutions, Stephen Smith, about modernizing clinical trials and providing new incentives for the development of drugs for rare diseases. This is great news to hear, but is a bit saddening to hear that it took persistent ‘lobbying’ by Mr. Smith to get this on Congress’ agenda. The amount of time and effort Mr. Smith put into getting this on Congress’ plate should be appreciated very much. However, the reminder that the clinical research community lags behind while other industries such as IT, banking, and even transportation strive to make improvements for their respective communities makes me wonder how many lives could have been saved with more proactive measures.
For the last few months, I’ve worked with CDISC’s Communications Department, honing our messages, reaching out to the media, working on speeches, writing stories, assisting with video work, among several other duties. I was also fortunate enough to participate in the creation of CDISC’s new marketing campaign “Smarter Research to Unlock Cures,” an initiative spearheaded by the Communications Department and developed by the marketing, advertising, and branding agency, Door Number 3.
I had never been to an International Interchange. Being involved with communicating all that CDISC is, I felt it was important for me to be in Chicago so I could learn as much as possible. It was certainly a crash course, and a very important one. In so many ways, I experienced the passion CDISC, and those involved with the organization, have for finding cures, and developing streamlined, harmonized methods to make sure everyone in the industry is aligned in order to find life-saving solutions.
(Koketsu ni irazunba koji wo ezu).
“If you do not enter the tiger’s cave, you will not catch its cub.”
Hydrangeas in Kamakura, one hour south of Tokyo
Every summer for the last four years, I have had the opportunity to visit Japan to assist the Japan CDISC Coordinating Committee (J3C) with our annual CDISC Japan Interchange. This year, those visiting Japan for the Interchange from around the world could enjoy temperatures far more pleasant than they were for the July 2014 Interchange, on average around 10°F/6°C lower. June is also the month for which Japan is famous for its 紫陽花 (ajisai), or hydrangeas, which were in full bloom, and can sometimes be as large as hedges. All around Tokyo and beyond, visitors can enjoy these brilliant shocks of luminous blues and purples. I always enjoy the Japanese seasons, as they are truly experienced in their fullest here. Celebration of the four seasons is actually an important part of Japanese culture, with festivals, poetry, music, art and more--all created to express appreciation for the changing of the time of year.
Yet another tenant of Japanese culture and values is the fundamental belief in collaboration and cooperation, working together toward a mutual goal. This comes from an idea that harmony results in benefits for the group as a whole. Concepts that are more challenging in the West, like consensus, are almost innate in Japanese society. Almost 10 years ago, when I lived and worked in Japan, one of my favorite things about the Japanese office environment was the work ethic of true collaborative effort, where no one person is any more essential than another, where each individual contributes to the greater whole (hierarchy in the office environment definitely exists in Japan, but I can honestly say that my former boss showed up at work long before I arrived, and was sure to leave after me, no matter how late I needed to work).
The 2015 CDISC Europe Interchange was by far the most successful event in the history of the CDISC Europe Interchanges. The Interchange was held in Basel, Switzerland, a beautiful city situated on the border of Switzerland, with sides touching both France and Germany. Basel is well known for its Romanesque, Renaissance and contemporary architecture, dotted with amazing small shops offering Swiss chocolate! 322 people attended this event, marking the highest attendance number compared to all prior CDISC Europe Interchanges. The conference was full of engaging presentations, including those from representatives from healthcare and regulatory entities that came to attend this event from around the world including the Japan PMDA, U.S. FDA, and EMA. Our Education courses were a great success, and attendance for the FDA Workshop that was offered on 04 May exceeded the maximum limit for registration! The networking event on 05 May was held on a boat that traveled the Rhine between the borders of Germany, France and Switzerland! Attendees were indulged with a fine Swiss dinner, amazing drinks and delicious desserts. An excellent time was had by all, and I am certain that this Interchange will not soon be forgotten.
What’s next on the way to 2020?
At the closing session of the CDISC European Interchange in Basel, Switzerland, the panelists from the FDA, EMA, PMDA, and CDISC were asked by facilitator Peter van Reusel for their vision and goals for CDISC as we approach 2020. What will CDISC look like in 2020?
Below is a list of goals and visions discussed:.
- How can CDISC better help patients? Communicate to patients and their families how CDISC standards can improve medical care for patients. Increase the level of data sharing. Patients will have access to their data as well as information from other patients to help them make informed decisions about their medical care.
- CDISC SHARE will help us develop, maintain and increase accessibility to harmonized standards starting with the protocol and carrying all the way through tabulation, analysis, reporting/submission and post marketing surveillance.
The CDISC Therapeutic Area User Guide (TAUG) for Asthma was the first standard developed under the collaborative CFAST (Coalition for Accelerating Standards and Therapies) Initiative. The CFAST process has incorporated new approaches to streamline the CDISC standards development, especially for specific Therapeutic Areas (TAs). The TA standards augment the CDISC Foundational Standards that are common across all TAs. Since the publication of the Asthma TAUG in 2013, CFAST teams have published 9 CDISC TA standards, and there are 11 projects currently ongoing through the CFAST process.
After 2 years of developing TA standards under the CFAST program, it was indeed welcome to hear of AstraZeneca’s positive experience in implementing this CDISC Asthma standard into their systems.
CDISC held the second face-to-face Standards Development Workshop on 7 May 2015 after the European Interchange in Basel, Switzerland. The goal of this workshop was to help projects, started in response to urgent global health needs, move forward in the development process. Teams had the opportunity to come together and have their work reviewed by CDISC standards experts. The five Specialty Area teams that participated in the workshop were Ebola, Malaria, Vaccines, Nutritional Research and Traditional Chinese Medicine (TCM). These teams are at different stages in the standards development process and have various goals and deliverables. Members of these teams live in different countries; in common, however, is their enthusiasm and dedication to creating global standards. This workshop provided a unique opportunity to meet in person and take advantage of the expertise available in Basel for the Interchange.
After a brief status presentation by each team, the focus shifted to a hands-on working session. Experts in Controlled Terminology, Metadata Development, Project Management and Standards Development, from the Critical Path Institute and the National Cancer Institute, attended the workshop to resolve issues, provide guidance and answer questions that arose during team discussions. A number of CDISC staff were also available to provide additional resources to assist the teams.
During the 2015 CDISC European Interchange I participated (among other things) on the discussion panel for Session 10: Metadata Repositories from the Pharma Perspective.The session was extremely well attended, indicating a lot of interest in the topic area.Speakers from three pharmaceutical sponsors presented on the status of their MDR implementations, followed by a session on SHARE and Research Concepts by Julie Evans of CDISC.Some of the takeaways from the presentations and subsequent panel discussion for this session included:
- The consensus legacy MDR for most companies to manage their standard metadata still seems to be that old standby, Microsoft Excel.
- There’s a great deal of interest in MDRs, but many companies are still trying to figure out what they do, why they’re necessary and how to prioritize an MDR versus other investments.