Expanding the Outreach of Therapeutic Area Standards for T1D and Crohn’s Disease

Expanding the Outreach of Therapeutic Area Standards for T1D and Crohn’s Disease

John Owen

Senior Project Manager, CDISC


With support from The Leona M. and Harry B. Helmsley Charitable Trust, CDISC is developing Therapeutic Area User Guides for Type 1 Diabetes (T1D) and Crohn’s Disease (CD). Treatments for these disease areas are available, however, exact causes of both diseases are still unknown. Helmsley supports global research in many areas of T1D and CD with the aim of improving the lives of people living with these diseases, identifying strategies to prevent onset of T1D, and to prevent as well as find a cure for CD. These CDISC projects align with the Helmsley goals to enable data sharing, cross-study comparisons and meta-analysis by standardizing clinical data, increasing efficiency in research to accelerate development of potential new therapies as well as finding new scientific links within and between disease areas.Support from Helmsley has provided access to a greater spectrum of medical researchers and key opinion leaders from academia and medical research institutions, innovative device and technology organizations, adding to the already strong CDISC community members involved in T1D and CD Research. These initiatives align with key CDISC goals and visions particularly in expanding the use of clinical data standards.

Type 1 Diabetes (T1D)

Building on the already published Diabetes Standards, the T1D project started in April 2018 with the formation of a multi-disciplined, multi-organizational scoping team to identify the key areas for T1D standards development.  Support from Helmsley has enabled CDISC to develop a larger set of concepts. As such, the project is split into three key areas:

  • Pediatrics and Devices
  • Exercise
  • Prevention

The development of the standards was divided into two phases. Pediatrics and Devices was the first phase of the project to enter the standards development stage; we are currently in the final stages of Internal Review. The 60-day Public Review phase of the Pediatrics and Devices standards is due to start in August 2019 and a public review webinar is planned to introduce these standards to the entire review community. We strongly encourage your participation in this review to provide your comments to ensure that the final published standards can be used by the largest implementer base. Publication of the Pediatric and Devices standards is planned for Q1 2020.

The Exercise and Prevention portions of the project are currently in the standards development phase and estimated to be available for Public Review in Q1 2020. Publication of the Exercise and Prevention standards is planned for Q2 2020.

We invite you to keep up to date with the project by visiting the CDISC T1D web page, which also contains the public webinars presenting the scope of all these areas of the T1D project.

Crohn’s Disease (CD)

The CD Project was initiated in January 2019 with the formation of a multi-disciplined, multi-organizational scoping team. This team is in the final stages of the scoping phase and plan to present the results of the scoping in a public webinar in August 2019. This webinar will present a summary of the topics planned for standards development for version 1.0 of the standards. The identified scope will focus on the key biomedical concepts that will provide the most useful information to the broadest implementer base. We encourage you to attend the scoping results webinar to keep informed of the topics under development. Additional information on the CD Project can be found on the CDISC Crohn’s Disease web page.

Information on our other public webinars can be found on the CDISC Webinar Web Page. CDISC implementers and volunteers are the cornerstone of the standards that we develop. I would like to take this opportunity to thank all our T1D and Crohn’s Disease volunteers for their valued participation in both exciting projects. Thank you!