CDISC Blog

The Learning Health System Summit took place on 17-18 May at the National Press Club in Washington, DC. It was the culmination of intense planning that occurred via phone several times monthly from the time of the CDISC Interchange in October 2011 (and even before, but that is when CDISC learned about this initiative). Dr. Charles Friedman gave a keynote address on his vision of the Learning Health System (LHS) at the CDISC International Interchange in Baltimore in October 2011 and spoke afterwards with then Board Chair, Dr. Frank Rockhold and myself about his plans to take this concept forward. [He had recently left his position as chief scientist in the Office of the National Coordinator to assume a position at the University of Michigan.] Chuck has published about the LHS in Science Translational Medicine (10 November 2010); directly aligned with the CDISC Vision, the LHS focuses on the fact that research data comes from healthcare and, in turn, should inform clinical care decisions. This cycle is said to take 17 years currently (for research results to end up in clinical decision support). As Chuck would say, we would like to see this go to 17 months, weeks or minutes!

The opportunity that took place last month was afforded by Mr. Joe Kanter of the Kanter Family Foundation and Kanter Health. He funded the LHS Summit; the Summit Planning Committee (including Frank Rockhold and myself) and was led by Dr. Friedman, assisted by Josh Rubin (Executive Director of Kanter Family Foundation) and students from the University of Michigan.

Joe Kanter encouraged the Planning Committee, when it was formed, with his story about having been diagnosed with prostate cancer 20 years ago and finding no available information on how to make an informed decision in terms of his treatment. He is now 88 years old and plays tennis daily – don’t we all hope for that?! He also opened the Summit: “We needed to put together a group that could create the Learning Health System. The Planning Committee deliberated for hours to determine who should be involved, and you are ‘the winners’. My frustrating experience with prostate cancer made me realize that I had to be an activist. We need to transform healthcare for our children. We pay more for less in this country. Fifteen members of the Planning Committee were brought together as an independent group to make a decision on who should be here and where we should go. Later today we will have the former ONC (Office of the National Coordinator of Health Information Technology) named by a Republican President and the former ONC Director named by a Democratic President. [Note that Harry Cayton also spoke from the UK perspective.] The time to act is now, and we need to act urgently. We are bringing our civilized nation into the cutting edge and should ask ‘What can an LHS do for us?’ AND ‘What can I do for an LHS?’ Together we will, in 2012, start the LHS.”

Dr. Friedman likened this event to the one at Dumbarton Oaks in 1944, which launched the United Nations. Chuck stated, in his opening remarks, that we cannot afford to go to 3rd base and not take this home (after which Harry Cayton made a comparison to cricket). Dr. Kolodner and Dr. Blumenthal mentioned the Moon Shot and the Manhattan Project and the World Wide Web as analogies. Needless to say, the expectations were high, as was motivation.

The Planning Committee had been working on a draft set of Principles and Core Values for several months. The LHS Summit invitees then spent an afternoon and the following morning in breakout groups reviewing the draft and providing comments, suggested revisions, concerns and positive input. At the end of the Summit, we had all “word-smithed” these substantially, and actually proposed adding one value, bringing the Core Values from 8 to 9. A show of hands confirmed that everyone was feeling that we were very close to agreement and that those present could sign onto these (or take them back to our organizations) with another iteration addressing the remaining ‘showstoppers’.

To ensure that this moves forward, following are the agreed next steps (as sent out by Dr. Friedman shortly after the Summit).

• Form a national “Learning Health Community” with the Summit attendees as the initial members
• Move very quickly to full consensus the fundamental “LHS Principles/Core Values” that were the focal point of the Summit discussions, with anticipation that CEOs of the organizations belonging to the Community will endorse
• Identify the minimum standards necessary for a national LHS---CDISC has volunteered to take the lead with this
• Stimulate an interest group to begin developing a governance for the LHS

There was also a very thorough press release about the Summit. See LINK to this and to the attendee list.

This is admittedly a US-centric activity at the moment (perhaps because we have one of the most problematic healthcare systems), but there was keen interest in a global view, especially for research. In the end, it all comes down to ‘data sharing’, which is certainly of keen interest to CDISC. As this is getting to be a long blog, I will address data sharing in another blog in the near future. Suffice it to say that this has become an increasingly ‘hot topic’, having been the theme of a recent NIH Workshop organized by NINDS, the topic of the chapter that Dr. Rachel Richesson requested I write in her newly published book on Clinical Research Informatics and the basis for CAMD and a new project with the CEO Roundtable on Cancer.

I will close this blog with a quote from Joe Kanter: “We are here for our families; that is why we are here. This is too big for any one person, and at the core of the LHS is one of the most underutilized resources --- the patients.” Having spent all day last Friday hearing testimony to the HIT Standards and Policy Committees on the theme of Patient Generated Data, there is every reason to agree with Mr. Kanter.

Dr. Rebecca Kush

President and CEO of CDISC