CDISC Blog  filter by date: June 2011

EHRs for Research---What do Representatives from FDA and HHS/ONC Think?

There was a whole new area in the DIA 2011 Exhibit Hall this year. CDISC announced, in a Press Release on 15 June, a partnership with IHE, HIMSS and DIA to bring the HIMSS Interoperability Showcase™ to DIA 2011 in Chicago. Not only were there a number of regulators who visited the demonstrations, but Terrie Reed of FDA CDRH participated in the showcase by demonstrating device safety reporting with EHRs as the source. Others demonstrated a process for using EHRs for clinical research. A Town Hall was held Tuesday afternoon to allow the regulators to express their reactions to the use of EHRs for research, particularly in light of the recent FDA draft guidance on eSource Documentation, and to allow the audience to ask them questions.

The Town Hall opened with each panelist providing brief remarks. I found these to be incredibly valuable, so I will do my best to recount the essence of at least some of what they said as accurately as possible (and will welcome their additional comments):

Dr. Leslie Ball, Director of the Office of Scientific Investigation (OSI), opened by asking the audience how many of them had navigated the DIA 2011 with the paper program? And, how many used the new DIA ‘Ap’ to navigate? And, how many had used both? She stated that this is an example of many of us who are caught struggling now between the two worlds – our paper past and the technology of the future. She commented that she now believes in EHRs, particularly since the site of her medical fellowship had converted to EHRs while she was there; this dramatically improved the availability of medical charts and x-ray images---suddenly they were all there, in the EHR system. No such seamless interface currently exists to get EHRs to communicate to the research world and Dr. Ball believes that we can get there. She stated that she would like to say we/FDA OSI support this effort, and she thanked CDISC folks for moving it forward. She feels it is a technical problem to be solved and closed by saying that it is only through the collective efforts of all in the room that we will solve it. Dr. Ball responded to questions from the audience about concerns on data quality in an EHR by asking back: “How do you assure the quality of the data in a paper medical record today?” She also commented that it would have been essentially impossible to falsify patient data in her experience with EHRs.

CDISC Global Relations - Europe and Japan

In Europe, CDISC was invited to attend and present at the Knowledge Management Workgroup meeting of the Innovative Medicines Initiative (IMI) at the eHealth Week in Budapest (10-12 May).  There is an MOU in progress between IMI and CDISC that will relate to the use of CDISC standards, when available, for IMI Knowledge Management and partnering on new standards development as needed.

Further CDISC Activities for 2011

More CDISC activities are already taking place in June…launching the CDISC summer in good form as we try to stay out of the Austin heat!   I hope that you don’t miss the DIA Annual meeting and, in particular the Interoperability Town Hall and demonstrations of EHRs as eSource for Clinical Research.  At the end of that, I will be heading for Washington, DC…. I am honored to have been invited by the Secretary of HHS and the new leader of the HHS/ONC to “represent research” as a new member on the U.S. HIT Standards Committee.   

CDISC Global Relations - Global Standards Development

The Joint Initiative Council (JIC) and ISO TC-215 for Health Informatics met the week of 22 May in Kuopio, Finland. JIC is a collaborative initiative between 6 SDO organizations (CEN, CDISC, GS-1, HL7, IHTSDO and ISO), and is focused on Health Informatics Standardization. These organizations and their communities are bound together by a common purpose...Standardization across the healthcare spectrum that leads to interoperability between independent systems, enabling compatibility and consistency for health information and data while reducing redundancies and duplication of effort. Leading up to the meeting in Finland, there were 6 JIC projects approved for joint work and balloting:

CDISC Spring 2011 – A Focus on Standards Progress

While the springtime was physically hot and dry in the southwest U.S. ---so much so that our normal Austin wildflowers were very sparse---there was a noticeable contrast in the CDISC spring activities!  There was so much going on for CDISC in April and May that it is difficult to know where to begin.  It makes sense to write several separate blogs that address the different areas of work CDISC staff and volunteers have been progressing for the past couple of months…since I wrote about the European Interchange.  I will begin with the standards development progress, then brief you all on the CDISC global relations and the activities within the global standards community that relate to medical research.

Progress continues within CDISC on the development of standards to support research in a number of therapeutic areas:   Pain/Analgesics (with the University of Rochester), Polycystic Kidney Disease (with Tufts University), Alzheimer’s Disease (with the Critical Path Institute), Oncology (with FDA and NCI), Cardiovascular Diseases (with ACC and Duke), Parkinson’s Disease (with C-Path and NINDS) and Tuberculosis (with the Gates Foundation and TB Alliance).   CDISC also responded to an FDA RFP for funds to continue Therapeutic Area Standards development. [Watch for the first TA “Package” on Alzheimer’s Disease coming soon.]   A presentation was made on the C-Path and Gates Foundation collaborations with CDISC (including progress on PKD, TB and Alzheimer’s standards and therapy development) at the Annual ACRP meeting in Seattle on 30 April.

CDISC Global Relations - China

CDISC Global Relations in May included a very productive collaboration with the Drug Information Association (DIA) during their 3^rd Annual Meeting in China in May.  The DIA kindly hosted a meeting of the CDISC China Advisory Committee (CCAC), which was launched by CDISC in Beijing in 2010 and is now chaired by Claire Tan of Quintlies (absent from the photo below as she is addressing the group at the front of the room).  Present were a number of experts in clinical research in China along with the DIA President of the DIA Board, the DIA Executive Director and representatives of the US National Cancer Institute (NCI) Julie Schneider (based in Beijing) and John Speakman (based in Rockville, MD).