Rethinking Clinical Trials

JANUARY 26, 2023

Discussion Themes – Is the trial being done under an IND or is it under label? The treatment is on-label because anyone with an acute coronary has at risk cardiovascular disease so technically it is on-label. The recruitment rate is higher than what you would expect in a normal ACS trial. Can it be done under an IND.

Trials 130

Trials Clinical Trials Clinical Trials Medicine 130

Rethinking Clinical Trials

FEBRUARY 13, 2023

This was not a dose finding trial and no nitrosothiol compounds were measured; the perfusionists in the study were not blinded; we allowed open label iNO; the choice of ventilator-free days as a primary endpoint can be criticized. There were a number of limitations.

Trials 130

Trials Clinical Trials Clinical Trials Research 130

Rethinking Clinical Trials

JUNE 7, 2023

The drugs were administered open label and all patients were given a low dose of aspirin. The primary endpoint was composite of valve thrombosis or valve-related thromboembolism, and the primary safety endpoint was major bleeding. The trial took place at 64 sites, and randomized 863 patients.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Cardiology 130