In February 2010, Tufts Center for the Study of Drug Development published an analysis regarding the industry adoption of Centralized Cardiac Safety and perceptions from stakeholders.
What did Tufts find?
97% rated central labs as being accurate
90% rate central labs as being efficient
Yet only 33% of all ECGs are collected centrally using a Core Lab
Furthermore, the findings showed it could cost up to $245 for a single “decentralized” ECG. The perception of sponsors and CROs is that collecting ECG’s locally is cheaper than the Centralized approach, yet the ‘hidden costs’ of data capture at site and associated data cleansing result in higher costs than using a Core Lab. The full report is available publicly in the ERT Knowledge Series section or by request to the Tufts Center for the Study of Drug Development.
