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17 Apr 2013


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.



12 Mar 2013

The CDISC vision is informing patient care and safety through higher quality medical research. This might be viewed as the CDISC contribution to a ‘Learning Health System’. When CDISC was founded in 1997, there was (and still is) a clear desire to streamline the means by which research information can be gleaned from clinical care to ultimately provide increasingly better knowledge to benefit patients. This desire was communicated as two key goals: 1) to make it easier for clinicians to do research, and 2) to improve data quality and patient safety.


You have heard this before, but we are all patients; and, those of us who have been working with CDISC for the past 1.5 decades are that much older and feeling an increased urgency towards accelerating the ‘research-healthcare learning cycle’. The 17 years that it is said to take for research findings to make their way back into clinical care decisions is simply too long, and we all know that healthcare costs continue to skyrocket without the resultant improvement in speed of innovation nor quality of care.

11 Feb 2013

On 23 January, the U.S. Health and Human Services Office of the
National Coordinator held the Standards and Interoperability Framework’s
kickoff webinar for their new Structured Data Capture Initiative. This
initiative seeks to define “necessary requirements that will enable
clinical data captured in an electronic health record during episodes of
care to be combined with additional data to supplement other purposes.”
One of these purposes is to ensure the reporting of serious adverse

11 Feb 2013

On 23 January, the U.S. Department of Health and Human
Services Office of the National Coordinator (ONC) of Health IT launched
a new initiative: Structured Data Capture (SDC). The specific challenge
that the SDC initiative is addressing is that electronic health record
(EHR) data has been of limited use for purposes outside of the direct
care of a particular patient due to “a lack of uniformity in the
terminology and definition of data elements across EHRs.” Thus, the SDC
Scope Statement is: “To define the necessary requirements that will
drive the identification and harmonization of standards to facilitate
the collection of supplemental EHR-derived data.” The initial use cases
are electronic case report forms (eCRFs) for research and safety
reports. The value of this initiative was cited in the slides and the
draft SDC charter:


“The identification and
harmonization of standards for the structured data capture within EHRs
will […] help reduce a) the data collection burden on health care
providers by enabling secure, single-point data entry that populates to
multiple systems and b) the need to make site-specific modifications to
EHR system capabilities in order to enable participation in important
reporting and research activities.”

10 Dec 2012

Large Simple Trials and Knowledge Generation in a Learning Health System


“Large Simple Trials (LST) and Knowledge Generation in a Learning Health System” was the topic for a meeting organized by the Institute of Medicine of the National Academy of Sciences. This meeting took place on 27-28 November, and I was invited to give a presentation with the prescribed title: “Getting to Comparable, Computable Data” in a session on infrastructure needs.



The meeting topic was very specific because there is a perceived need to run more LSTs and the planning committee wanted to explore why there are so few of this type of study actually conducted. Although difficult to find, there were a few examples cited and/or described during the meeting, mostly observational studies conducted by academic universities: Harvard University (VITaminD/OmegA3 – VITAL), Brigham and Women’s Hospital (Post-Myocardial Infarction Free Rx Event and Economic Evaluation (MIFREE), McMaster University (Heart Outcomes Prevention Evaluation -HOPE). There were no regulated research studies recounted.


13 Nov 2012

Session 4 of the CDISC International Interchange conference on 24 October was especially stimulating. It consisted of short, well-delivered and extremely inspiring and promising presentations from various organizations seeking faster and better therapies for patients. A key message: One of the crucial factors to expedite the process of finding new therapies is ensuring the sharing of accurate data through standards.



Everyone is going to be a patient, and we all happen to know someone with a brain disorder, Dr. Magali Haas of One Mind Research opened her presentation. Dr. Haas spoke of the ‘moon shot’ initiative of President John F Kennedy to put a man on the moon; it is based upon this successful challenge that Patrick Kennedy has now launched the One Mind initiative to cure brain disorders in this century. Dr. Magali stated, “We will not accomplish this without common standards for data. We need to integrate solutions and new practices to improve the quality of lives. CDISC is one of the key organizations that will ensure the development of common data elements for traumatic brain injuries.”



Dr. Charles Hugh-Jones of sanofi, DataShare and the CEO Roundtable on Cancer apprised the audience on the ongoing project of implementing data sharing among biopharmaceutical companies within the environment of Oncology.

13 Nov 2012

Apparently we were so focused on making this the best Interchange ever that we failed to realize it was our 10th CDISC International Interchange. It dawned on some of us mid-week. The first CDISC Interchange was held in 2003, and Dr. Mark McClellan was the keynote speaker. Dr. McClellan was the FDA Commissioner at the time and, in speaking about the benefits of technology during his keynote, he was quoted as saying: “I think that CDISC will be a big part of moving FDA onto an electronic information architecture where we can realize all of these opportunities. I think this will have a profound and positive impact on our drug review process, allowing us to design trials that can be less expensive and still tell us more about the risks and benefits of a new medical product. And I think that the most significant and perhaps enduring legacy to your efforts could be the very immediate and significant impact it has on improving the lives of patients.”



Dr. McClellan also spoke of the FDA being a ‘fire hazard’ with so many boxes of paper in storage. The FDA has now moved to their White Oak Campus with far more space and, interestingly, Dr. Janet Woodcock (Director of FDA/CDER) who gave the keynote this year in Baltimore, said that she was told by their document room that they had to ‘stop’….meaning that there is no more room to bring any more paper into the FDA. Speaking specifically about standards, she raised an analogy of the Baltimore fire of 1904, during which the city burned because fire trucks from nearby fire departments did not have hoses that would fit on the Baltimore fire hydrants – there were no fire hose standards!

9 Nov 2012

FDA Public Meeting on Transport Standards – 5 November 2012 On 5 November, the Food and Drug Administration (FDA) announced a meeting entitled “Regulatory New Drug Review: Solutions for Study Data Exchange Standards” with the purpose of soliciting input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. The meeting was held at the FDA’s White Oak Campus in a large room with ~ 15 round tables, each seating 5-8 individuals (i.e. about 100 attendees). There were at least a dozen FDA representatives present, 5 with speaker/facilitator/presenter roles. This is simply a brief summary with the key points that came across to me, with a goal of reporting this objectively.



Mary Ann Slack (FDA, CDER OPI) opened the meeting reiterating the purpose to get industry input, objectively without debates. She said that they really wanted to have a discussion and that they will provide an e-mail address for thoughts that folks would like to send, even after the event. She cited some scenarios that will be placed on the FDA website to convey the ‘pressing challenges’ that FDA has with respect to receiving and reviewing data. Ms. Slack highlighted a few of the comments that were received in writing, including the need for high quality standards across the spectrum of research, recommendations including an end of Phase II data standards meeting for those developing new treatments and the need for more consistency---governance is key, she said.

29 Oct 2012

CDISC International Interchange 2012 initiated with one of the most interesting educational sessions that I have ever attended in a very long while, Train the Trainer session! The session took place on Sunday, 21 October 2012 at the Renaissance Harborplace Hotel in Baltimore, MD. This course was developed specifically for CDISC authorized instructors so that CDISC training can be delivered in the best possible way to our members and stakeholders.





The session was tailored to train instructors and presenters on global teaching and presentation skills that would motivate and stimulate the profound attention of the attendees in the material delivered. The session started at 9:00 AM and was supposed to end at 5:00 PM, but it did not end until 5:45 PM where active participation and excitement of discovery kept the attendees interested until the last minute. Attendees, who are also CDISC instructors were urged to participate continuously, analyze and discover new ideas and training methods throughout the day. Creative and positive input led to self-discovery of new teaching techniques, this atmosphere of active and analytical participation helped the attendees discover a new variety of interesting and exciting teaching methods even before they received instructions and notes from the instructor.

21 Aug 2012

The FDA recently published their announcement of a public meeting to discuss Solutions for Study Exchange Standards. The notice includes directions for how to register to attend the meeting (the email address, however is incorrect. Please refer to correct address at the end of this entry), and also a list of questions related to the use of standards, including asking for input on comparing HL7 transport standards to CDISC ODM.



This may be our best opportunity to convince FDA that an XML transport standard based on ODM for CDISC SDTM, SEND and ADaM content would be a better solution for submitting data than use of HL7 healthcare standards. We believe this forum will highlight the advantages of using the CDISC Operational Data Model (ODM), which is the basis for define.xml and a current component of the FDA study data standards. ODM has been successfully adopted by many researchers in both industry and academia, as well as technology vendors for transferring clinical data, metadata and terminologies with audit trail in a fully compliant manner.