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25 Nov 2015

I’ve been thinking about what makes face-to-face interaction so valuable. The Interchange hasn’t officially started yet, but I’ve already been here a day and a half, helping to set up, attending a CFAST meeting and a CAC meeting, and meeting people at registration. Part of it, for an old hand like me, is the opportunity to hug people I don’t see often.

24 Nov 2015

The patient was the main character in the 2015 CDISC International Interchange.  Whether it is our friends, family, neighbors, or ourselves, we are all patients.This year’s Interchange focused on the patient and how quality data ensures that the patient is receiving the best possible care and treatment and how quality data can unlock cures.Patients and families now have access to much more information and truly do want to share their data to improve healthcare, but without standards, this data is often very difficult to share. 

24 Nov 2015

“Is SHARE available now?”
“How do I access eSHARE?”
“What kind of metadata is available in SHARE now?”
“What can I do with SHARE metadata?”
“What is new in SHARE for 2016?”

 

 

This is a sample of frequently asked questions at the SHARE booth during the Interchange; the SHARE and eSource demonstration booths were conveniently situated outside the conference break room, where attendees enjoyed their meals and refreshments. With guaranteed foot traffic, the location maximized our opportunity to socialize SHARE’s values and benefits. We set up a TV monitor at the SHARE booth, looping a presentation slide deck that details what the team accomplished in 2015 and planned for 2016. To the right was the SHARE poster set on an easel. The CDISC model on the poster facilitated many conversations. It diagrams the lay of the land of all CDISC products in a simple way. It depicts product relationships and identifies SHARE deliverables in a single bird’s-eye view.

23 Nov 2015

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.

23 Nov 2015

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."[1] 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.

22 Nov 2015

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.

22 Nov 2015

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. 

28 Jul 2015

虎穴に入らずんば虎子を得ず。

(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).

22 Jun 2015

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.

22 May 2015

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.