Academic Research Consortium (ARC)
The purpose of the ARC is to create a dynamic, transparent and collaborative forum for stakeholders to develop consensus definitions and standard nomenclature in pivotal clinical trials of medical devices and to disseminate such definitions and recommended processes into the public domain.
The ARC was founded in 2006 as an informal collaboration between clinical experts and 4 academic research organizations - the Harvard Clinical Research Institute (HCRI), Cardialysis, the Cardiovascular Research Foundation (CRF), and the Duke Clinical Research Institute (DCRI) - with advisory participation of the U.S. Food and Drug Administration (FDA) and other regulatory bodies across continents. Thought leaders from the medical industry are centrally involved as non-voting participants.
The group first focused on key definitions for application in coronary stent trials, conducting a series of "think-tank" meetings and publishing the consensus document in peer review literature in 2007. In the meantime, a number of ARC initiatives have been successfully completed:
- for characterization of bleeding complications in cardiovascular trials (bleeding ARC = BARC)
- for percutaneous valve studies (valve ARC = VARC)
And currently, several other ARC efforts are underway in areas of key definitions:
- for peripheral intervention (peripheral ARC = PARC)
- for atrial fibrillation (AF-ARC)
- for Bioresorbable Vascular Scaffolds (BRS-ARC)
- for antiplatelet therapy: Adherence-Academic Research Consortium (A-ARC) - Program A-ARC