2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials

“We developed a standardized vocabulary for documenting and reporting critical cardiovascular adverse events, along with specifications for the exchange of that information between computer systems. The key use will be in reporting findings to the FDA, whether in the context of clinical trials, pharmacovigilance, or device surveillance. Ultimately, we anticipate widespread adoption of this vocabulary throughout healthcare (including routine clinical care) as a catalyst for accelerating improvements in patient management and treatment.”

“It's not like these are small trials of rare disorders where you might say, 'OK, this is what we looked at.' These are very planned out studies.”

“How you define something, whether it's rehospitalization or need for revascularization, for example, these are the sorts of things that have some discretion to them and could potentially lead to bias.”