ARTICLE | Tools & Techniques

Heartening predictors in diabetes

How the diabetes and CV fields should organize to gain new biomarkers

February 15, 2019 3:03 AM UTC

New biomarkers of cardiovascular risk could relieve a decade-old bottleneck for diabetes drug development, but validating them will require companies to invest in strategic trial designs, and public and private stakeholders to pool thinking.

As diabetes companies await new FDA guidelines that might do away with the blanked requirement for costly post-market cardiovascular outcomes trials (CVOT) that have hampered progress over the last ten years, they also anticipate increased pre-market CV requirements that could negate some of the savings, making it unclear how much new development the change will spur (see “Cashing Out CVOT”)...