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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.

21 Aug 2012

CDISC would like to thank all those who followed the metadata patent issue. Late last week the US Patent Office officially issued a “Final Rejection” notice to the patent applicant. According to the US Patent Office: “A final Office action," in this case a final rejection, “issues when the applicant's response to the prior Office action fails to address or overcome all issues. An applicant’s only response to a final Office action is either compliance with the requirements or appeal to the Trademark Trial and Appeal Board.”


8 Aug 2012

In January 2012, CDISC was contacted by Nanping (Lisa) Li, Healthcare
Strategy & Business Development Executive, IBM, who informed us
that CDISC would be an important focus for IT standards in China, in
particular, with respect to a new program that has been launched between
China and the US through AmCham. Ms. Li sits on the Steering Committee
of the Healthcare Cooperation Program (HCP).




to a Press Release from 26 June: “AmCham China's Healthcare
Cooperation Program (HCP) today signed a memorandum of understanding
(MOU) with the Health Human Resources Development Center of the Chinese
Ministry of Health, opening a path to increased cooperation. The MOU
will help foster multi-level exchange between China and the US in the
healthcare sector and provide a platform for high-level US-China
dialogue on healthcare reform, medical personnel training and technology
exchange.” See this link for the full press release.


According to Jun Zhou, Executive Director, AmCham is
working to make it easier for companies to do business in China; his key
project is the Healthcare Cooperation Program. The two workshops that
AmCham and IBM planned, with CDISC as a core theme, took place in
Beijing on 16 July and Guangzhou on 19 July. AmCham and IBM sponsored
the workshops, along with support from CDISC, especially Sheila Leaman,
CDISC Manager of Global Relations.



7 Aug 2012

Winner gets the CDISC Innovation Award with Recognition from HHS-ONC, DIA, FDA and CDISC!



At this year’s DIA meeting in Philadelphia on 26 June, CDISC, HHS/ONC and FDA issued a ‘challenge’ to use EHRs for regulated research. Specifically, research study sponsors were challenged to use at least two different electronic health record systems at different sites to conduct a multi-site, multi-visit, standards-based regulated research study. The panelists at DIA spoke on the feasibility of this challenge, based upon technology and data standards and processes that have been developed over the past decade. In addition, a case study was presented during this session about a research study being conducted currently at Florida Hospital using the Cerner EHR system. Despite the potential and demonstrated benefits of this approach, the clinical research industry has not yet embraced these new methods and standards to conduct research studies.


This challenge will provide FDA, HHS/ONC and CDISC a means to assess the remaining barriers as well as the opportunities to streamline regulated research and increase its capacity throughout the US and the world as EHR adoption is being encouraged and increasing rapidly. Wayne Kubick, Chief Technology Officer (CDISC), spoke first at the DIA session: “CDISC has been doing demonstrations of its Healthcare Link methodology for years now, at HIMSS and at DIA. By adopting the CDISC-IHE profiles used in the CDISC Healthcare Link solution, EHRs can readily implement the standards and profiles to enable the collection of a high quality research dataset that is needed for any regulated research study.”


6 Aug 2012

The CDISC China Coordinating Committee (C3C) was initiated in 2008 when Sandy Lei of J&J came to China and initiated a CDISC group. President, Rebecca Kush, also visited that year and a half-day workshop was held with Lei and Kush as speakers. The first Chair, Simon Wang of Parexel, was elected and a Charter was written. The C3C has since sponsored two Interchanges at Fudan University and more recently initiated a great group that has been validating translations (provided by Absolute Systems Clinical Data Co., Ltd.) and performing translations of the CDISC standards into Chinese. This group is known as CSTAR (CDISC Standards Translation and Review).