ODM, CDISC's Operational Data Model, version 1.x will be 17 years old in October, making it a mature standard. ODM has come of age, and it's time for ODM to take on a bit more responsibility around here. Toward this end, a new XML Technologies development team has recently started work on ODMv2, a substantially updated version of ODM that breaks backwards compatibility with version 1.3.x to add a number of significant new features. This post highlights some areas of new development for ODMv2. As ODMv2 is still in the early stages of development, the scope of the project and specific features are subject to change. Read the latest entry from Sam Hume, Head of Data Exchange Technologies, CDISC.
Dr. Hans-Georg Eichler, Senior Medical Officer, EMA, provided the closing plenary keynote speech entitled “Data standardization: (how) important for tomorrow's knowledge generation?” The presentation discussed the efficiency of knowledge generation in medical research and the need for augmenting knowledge generated by randomized clinical trials (RCTs) with other sources of knowledge generation. RCTs are geared to provide safety and efficacy assessments, but must be augmented with data on effectiveness of medical products. Data on effectiveness can be harvested from an increasing number of non-traditional sources, such as patient-level data sharing, sharing of comparator data obtained from RCTs, observational data, mixed treatment comparisons. Read the entry from Barrie Nelson, CDISC's VP, Standards, Terminology and Technical Services.
We load the CDISC Controlled Terminology (CT) published by the NCI Enterprise Vocabulary Services (EVS) into the SHARE metadata repository (MDR). When we're through catching up with our backlog we'll have more CT in SHARE than any other type of metadata, and we'll publish the quarterly CT content to the SHARE Exports page on the CDISC web site. One of the main differences in how we load the CT is that we load only the incremental changes. That is, we load the differences by generating diff files that contain only the changes between the packages published in the current quarter and those published in the previous quarter. The diff files are available for download, or they can be generated using the NCI's Diff program. This program is a Java application, and it is simple to set up on most machines. Read the entry from Sam Hume, Head of Data Exchange Technologies, CDISC.
If you're wondering where the XML standards like Define-XML went on the CDISC website, they've moved. They're now located under Standards/Transport. If you go to the transport page you can select from a fairly extensive menu of transport standards. There are a few transport options located elsewhere, such as Lab and the Analysis Results Metadata Define-XML extension. Read the post from Sam Hume, Head of Data Exchange Technologies, CDISC
Keeping your repository up to date with the latest CDISC Controlled Terminology (CT) packages represents a challenge to many organizations. The SHARE API make it easier to retrieve the CT packages and initiate the process of updating your repository. In this post I'll walk through the process of finding and retrieving the CT from SHARE using the API. Continue to read the entry from SHARE Team Member, Sam Hume, Head of Data Exchange Technologies, CDISC
Having completed the SHARE API v1.0 pilot in 2016, CDISC recently announced the SHARE API Early Adopter Program for those interested in beginning to use the API right away. SHARE API access provides a RESTful web services interface to SHARE for retrieving new CDISC standards and terminology. Read more from SHARE Team Member, Sam Hume, Head of Data Exchange Technologies, CDISC
It has been known for some time that the “one size fits all” model for prescribing therapy does not benefit all patients. Some people will respond well to a certain medication, whereas others will have a reduced response, if any, and a portion may even experience adverse reactions.
Researchers have traditionally been rewarded for innovation and being the first to publish unique results. Unfortunately, in a new era promoting collaboration, such a culture presents barriers to sharing information in a timely and useful manner and, in turn, to bringing therapies to patients sooner. Certain organizations such as One Mind are trying to change this culture.
The theme of the 2015 One Mind Summit was “Open Science and Collaboration in Action.” Examples of One Mind collaborations were presented by key opinion leaders, while barriers to further collaboration were identified in a fluid exchange of great ideas mixed with cautious optimism about what changes can actually be achieved.
Impediments to successful collaboration in Traumatic Brain Injury (TBI) discovery in the U.S. were shown on a slide by one of the world’s leading experts in this field during the panel discussion “TBI: A Field Moving from Competition to Collaboration.” These impediments, which are not limited to TBI, include:
- A societal culture that values individual discovery;
- An NIH funding culture that favors individual research and discovery;
- An NIH funding culture that emphasizes innovation and impact, which are not necessarily major components of collaborative research.
It was my privilege to chair the "Standards from the Start" session at the Interchange in Chicago this year. We had a great lineup of presenters who walked us through CDISC standards solutions to support increased efficiency and quality through the use of standardized protocol templates, standardized CRFs and standardized metadata repositories.
I’ve been thinking about what makes face-to-face interaction so valuable. The Interchange hasn’t officially started yet, but I’ve already been here a day and a half, helping to set up, attending a CFAST meeting and a CAC meeting, and meeting people at registration. Part of it, for an old hand like me, is the opportunity to hug people I don’t see often.