nejm.org/doi/10.1056/NE…
1- Establish indep CV outcomes committee for adjudication
2- Enroll high CV risk/existing ASCVD pts in anti-diabetic med trials
3- Neat stats (cont below)
3- Pre-marketing, the upper bound of 95% CI should be <1.8 with a reassuring point estimate.
4- A postmarketing trial is recommended to show that the upper bound 95% CI is < 1.3.
Result -> since 2008, every novel anti-diabetic has undergone dedicated CV outcomes trial
Nice review: ncbi.nlm.nih.gov/pmc/articles/P…
1- Ethics eventually➡️benefit, even if it takes time. Investment in evidence-based med➡️new science, better pt care and bigger ROI
2- Never underestimate the impact of data-driven observations. Report them!
Inspiring story for scientists and clinicians!!!