Late breaking clinical trials (LBCT) at ACC are always very very interesting, but today we apparently learned two new ways how NOT to make a light bulb and HOW we might design trials (adaptive study design) to quickly find out if a new medicine works or not.
I just attended an LBCT which had two negative trials. LATITUDE-TIMI 60 and the CARIN trial were interesting approaches to promising medicines in Acute Coronary Syndrome (ACS) and sudden kidney injury. The two medicines didn't work, yet there is hope for the new adaptive study design that was used.
Some colleagues frown at a negative trial, but let's make lemonade from those lemmons. LATITUDE should be given some lattitude because the patients who did have a STEMI trended toward benefit AND the dose used in the study may not be the best dose. Contrast Induced Kidney Injury is a prevalent challenge which may be modified if not prevented by a 12 hour hydration. The study was designed to show the benefits of CMX-2043, but is also showed that hydration as a preventative approach was only used in half of the patients.
WHY ??? It takes 12 hours of IV and the realities of our healthcare system according to Dr. Bhatt (the presenter) are that the increased length of stay and the flow of admission and pressures to discharge may have precluded that approach. From my perspective, there is clearly something wrong with this picture. Why not protocoiize the requirement for hydration prior to high osmolality contrast AND vet that increased length of stay through the insurance carriers.
The clear star of this morning is the adaptive study design that was used in the two studies I mentioned. If you visit www.clinicaltrials.gov and look at the design, you will see a new, efficient, effective an economically sound approach that is something I think you will see in many many upcoming studies.