New therapeutic area standards for diabetes will make clinical research with diabetic patients more efficient and enhance diabetic treatments. The Clinical Data Interchange Standards Consortium (CDISC) and TransCelerate BioPharma, Inc. released the standards from the Coalition for Accelerating Standards and Therapies (CFAST), which is a joint initiative of CDISC and the Critical Path Institute (C-Path).
These standards follow the release of ten guiding principles for the provision of healthcare in diabetic treatment from the National Institutes of Health. Similar to the NIH’s intention for the guiding principles, CDISC and TransCelerate hope to improve the quality of life of patients living with diabetes.
“I see the need for these guidelines on a daily basis,” said Rachael Zirkle, project manager of diabetes therapeutic area standards at CFAST, in a news release. “Establishing universal guidelines can help to both facilitate higher quality diabetes research, and to help effectively and safely treat people with diabetes.”
Overall, the goal is to provide metadata vital to interpreting data from clinical trials in order to draw the best conclusions for the best treatments. The standards describe data most commonly needed in the context of diabetes research and give examples of data use in clinical situations.
CDISC provides a wide selection of standards for various disease conditions. In addition to diabetes, multiple sclerosis and cardiovascular disease are among the conditions for which standards exist. “The CFAST project continues to develop an ever-increasing number of therapeutic area standards,” said Rhonda Facile, senior director of Standards Development at CDISC. “This body of work, coupled with work done on CDISC foundational teams and prior therapeutic area standards, is making it possible to reuse common standards domains and information developed across therapeutic areas. This is an anticipated and exciting development that will, over time, speed up therapeutic area standards development.”
