CDISC is known for its ‘strength through collaboration’ and for convening teams in ‘productive collaboration’. Our relationships with other organizations are extremely important and meaningful for CDISC and we would certainly not have made the same progress without them. We would like to highlight key relationships in this area of the website, acknowledging that there is no way we can mention all of the important ones that come into play daily for CDISC.
1. Innovative Medicines Initiative (IMI)
a. In 2012, CDISC continued an extremely valuable partnership with IMI and provided a second educational session at the IMI central offices in Brussels. All IMI consortia were encouraged to send participants. CDISC is currently a partner on three major project consortia.
i. The EHR4CR project (Electronic Health Records for Clinical Research http://www.ehr4cr.eu) is in its third year and CDISC is contributing to the semantic interoperability and pilot work packages. EHRCR is, to date, one of the largest public-private partnerships aiming at providing adaptable, reusable and scalable solutions (tools and services) for reusing data from Electronic Health Record systems for Clinical Research.
ii. The BioVacSafe project (Biomarkers for Enhanced Vaccine ImmunoSafety http://www.biovacsafe.eu) kicked off March 2012 with the first annual meeting. The goal of BioVacSafe is to develop cutting edge tools to speed up and improve the testing and monitoring of vaccine safety, both before and after release to the market. CDISC is working with Charité University in Berlin on the data collection and management system to ensure conformance with CDASH, SDTM and Controlled Terminology standards.
iii. The eTRIKS project (European Translational Information & Knowledge Management Services http://www.etriks.org) was launched in November. CDISC is leading the data standards work package with Roche and IDBS. Building upon the open source tranSMART system, eTRIKS will provide 1) a sustainable Knowledge Management Platform and Service to support Private/Public Translational Research (TR) across IMI and 2) a single access point to standardized curated TR study information. eTRIKS will bring data together from key IMI projects, many focused on Therapeutic Areas such as severe asthma, rheumatoid arthritis, depression and schizophrenia, tuberculosis, as well as breast, colon, prostate and lung cancer.
2. The Translational Research Informatics (TRI) Center
a. In 2012, TRI, which is funded by the government of Japan, trained a CDISC expert education instructor (the first in Asia) and continues to encourage all of its academic partners to use CDISC standards. Additionally, TRI published CDISC as the Global Standards, a publication featuring all articles discussing CDISC that had originally been printed in the Japanese medical journal Rinsho Hyoka (Clinical Evaluation) in 2012.
3. The Critical Path Institute (C-Path)
a. C-Path remains a strong partner with CDISC. C-Path makes the CDISC standards tangible by testing them through development of valuable research databases that are aggregated using CDISC standards to ensure scientific integrity of the content. In 2012, CDISC and C-Path launched a new initiative called Coalition For Accelerating Standards and Therapies (CFAST), described under our 2012 Milestones. Through the CFAST initiative, a new process for accelerating the development of therapeutic area standards was created (based upon lessons learned from previous therapeutic area projects where CDISC and C-Path collaborated). This is now being tested in a new area, Asthma.
4. TransCelerate BioPharma (TCB)
a. Formed in 2012, TCB is a non-profit organization formed by 10 global healthcare and pharmaceutical companies with the goal of improving the quality of clinical studies and enabling new medicines to reach patients faster by facilitating the collaboration required to solve common challenges encountered during the clinical trial process. There are five projects, one of which is standards development and is an incentive for the CFAST partnership between CDISC and C-Path – to speed TA standards development. TransCelerate will provide greater access to resources from the pharmaceutical industry that will contribute to standards development projects.
5. National Cancer Institute Enterprise Vocabulary Services (NCI EVS)
a. NCI EVS has been providing CDISC with expert services to develop and maintain its controlled terminology since 2005. This invaluable and essential partnership continues to expand with NCI EVS providing critical terminology support and resources for CFAST therapeutic area projects. Additionally, NCI EVS provides terminology services to other key partners such as US FDA and many NIH Institutes (e.g. National Institute of Child Health & Human Development). NCI is also a key stakeholder organization for the BRIDG model.
6. The Learning Health Community
a. CDISC was involved in the planning of the first Learning Health System Summit in May 2012. Sponsored by the Joseph H. Kanter Family Foundation and working with Dr. Charles Friedman of the University of Michigan, the outcome of this Summit has been a set of Core Values for a Learning Health System and a growing Community. During the Summit, CDISC agreed to lead one of the critical initiatives of an LHS – identifying a core set of standards to enable learning, i.e. an important link between healthcare and research. CDISC has endorsed the LHS Core Values and the Essential Standards to Enable Learning (ESTEL) initiative was christened in November 2012. Dr. Rebecca Kush, CDISC President and CEO, also represents Research on the U.S. Health Information Technology (HIT) Standards Committee.