December 15, 2011 at 3:28 PM by cdisc
The Oncology Colloquia was one of six Colloquia sessions held during the CDISC International Interchange 2011 on 6 therapeutic areas: Oncology, Virology, Pain, Diabetes, TB and Imaging. Bron Kisler, VP of Strategic Alliances at CDISC, initiated the session introducing himself, Bron’s background with CDISC is on Terminology. He was one of the first people with CDISC to work on Therapeutic projects beginning with the TB and Acute Coronary Syndrome projects back in 2006. “We have seen growing interest in disease specific standards from the CDISC community and FDA as well as communities new to CDISC including NIH institutes, foundations and professional societies”, Bron mentioned. He also stated that one of the nice things about Oncology is that we don’t have to start from scratch due to the great work already done across the National Cancer Institute (NCI) community. During the meeting, Dianne Reeves from NCI provided an in-depth orientation of this work, which was followed by a working session.
The attendees, who were also active CDISC team members, represented a good cross-section of organizations: Astrazeneca, Celgene Corporation, Critical Path Institute , eClinical Solutions, Eli Lilly, FDA, GlaxoSmithKline, Genentech, NCI, Otsuka Pharmaceutical and Pharmastat. CDISC and C-Path are partnering on numerous disease projects with 9 therapeutic areas in the works and at various stages of development. CDISC is so pleased to be partnering with the C-Path team out of Tucson, AZ on this new work as they bring incredible value including their project management expertise. It was also exciting to hear that FDA was very pleased with the growing CDISC C-Path relationship.
Bron then identified the key areas that are currently going on in Oncology: 1. the work being done by NCI to develop common CRF data elements (aka CDEs) across all cancers presented by Diane Reeves from NCI; 2. an update was given by the SDS Oncology team regarding the current status of the new SDTM Oncology domains; 3. as well as the update by Chuck Cooper from FDA on the regulatory perspective and FDA’s interest in Oncology. The colloquia attendees then dived a little deeper into the SDTM Oncology domains as well as the NCI CDEs. Diane Reeves from NCI kicked-off the session by talking about the Cancer Biomedical Informatics program at NCI that was launched in 2003 and the great work that has been done across the full NCI community. There is an impressive body of work totaling nearly 400 CDEs and definitions for cancer. This work became the cornerstone of discussions during the oncology colloquia.
CDISC was pleased to hear the update from Chuck Cooper of FDA who provided an overview and background on Oncology from FDA perspective, mentioning that one of the main projects for FDA reviewers is to embed-in some statistical programming with actual reviews. Chuck then talked about an Oncology review that was conducted due to the availability of the SDTM Oncology domains and mentioned that FDA is interested to know how these domains would support the review activity and how the standards could help facilitate the review process. He also indicated working with experts from the CDISC SDS team to identify gaps between the review data and the oncology domains, which will help determine future work needed to address oncology data. Chuck continued by mentioning that they are putting a mechanism in place to allow reviewers to start conducting the analysis upon receiving the data. FDA was interested in the Oncology Colloquia to learn more about additional activities in oncology and how these activities would match some of the requirements that their reviewers are identifying.
The Therapeutic Area Standards represent a very inspiring new area of standards which is of utmost importance within this digital era! Therefore, utilizing the correct and accurate data from the beginning as well as ensuring the shortest time possible for patient remedy cannot be achieved without Therapeutic Area Standards!
Please stay tuned to our website for any updates regarding the Therapeutic Area Standards. New updates are coming very soon!
Diana Harakeh, CDISC, Manager of Communications