June 15, 2011 at 10:48 PM by cdisc
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.
Another area of standards progress is the FDA “Issues” list, which was announced in the last CDISC eNewsletter. This is a document that provides more specification in terms of exactly how the CDISC standards, specifically Study Data Tabulation Model (SDTM) and Analysis Dataset Model (ADaM) should be implemented in eSubmissions. Concurrently, an Amendment to SDTM 3.1.2 has been posted for public comment. It is felt that the “issues resolutions” provided in this documentation will help ensure that regulatory submissions will receive higher quality reviews since they will enable the use of review tools and reduce the time FDA reviewers spend preparing data for reviews.
It goes without saying that, if there is any chance that research studies may become part of a regulatory submission, it makes sense to collect the data in CDASH format. This will streamline the flow of much of the data (at least the core data) downstream since it will be in a format (with controlled terminology) that is compatible with and supports the requested eSubmission data formats (SDTM and ADaM). This not only helps the regulatory reviewers but saves time and costs for the study sponsor as well. The enhanced development of therapeutic area standards will complement the existing core standards and augment the value of the standards.
CDISC SHARE and BRIDG continue to progress; see a separate update of SHARE by Rhonda Facile and Frank Newby.
In another area of the clinical research process-- the ‘front end’ I call it, the CDISC XML team has developed an extension of the Operational Data Model (which provides a transport standard to support eCRFs and the transport of case report form data). This extension supports the Study Design Model (SDM) and is called ODM-SDM. This is an exciting opportunity that will enable the transport of information on a protocol design, which can be used in study start-up, study tracking and also reporting so that those reviewing the data from a study can comprehend the plan that was in the protocol in the first place. This is posted for open public review.
The SDM is also being used as the basis for research that CDISC is doing with Mayo Clinic and other collaborators on the HHS/ONC awarded Strategic Health and Research IT Projects (SHARP) in the area of Secondary Use of EHRs. What a savings in time and resources we could achieve if an EHR could be programmed to schedule patients for a study and even launch the cue for an eCRF to pop into an EHR window with part of the fields populated. The latter capability is part of the CDISC Healthcare Link Initiative and will be demonstrated at the Annual DIA meeting 19-23 June in Chicago!
Many thanks to all of the CDISC volunteers who have contributed to this progress!