ERT , a global provider of technology and services to the pharmaceutical, biotechnology and medical device industries, announced the availability of a new report, conducted by the Tufts Center for the Study of Drug Development, mapping the growing adoption of centralized ECG (electrocardiogram) services. The industry-wide report measures the current and anticipated adoption levels of centralized ECGs in clinical trials. This document, entitled "Mapping Adoption of Centralized Cardiac Safety Assessment," is available to download from the company’s Centralized Cardiac Safety microsite – www.ert.com/ecg.
The new study, supported by an unrestricted grant from ERT, focuses on the use and adoption of digital and electronic ECGs and reports industry perceptions regarding the use of a centralized cardiac safety assessment provider in support of clinical studies. While the study reported only 33% of respondents currently use a centralized ECG approach, 89% of respondents expect the use of centralized ECGs to increase in five years. The significant increase in centralization is anticipated due to regulatory pressures and sponsors’ needs to provide high quality data being highlighted as the key factors to drive significant adoption.
The results confirm that respondents feel that centralized core labs are a valuable way of conducting cardiac safety assessments and most executives that were interviewed believe that 100% of all cardiac safety studies will eventually be handled by centralized providers. Ninety-seven percent of respondents rated central labs as being more accurate, and 90% rated them as being more efficient than a decentralized approach. Despite the reluctance to deviate from using a decentralized approach due to financial concerns, the Tufts report demonstrates that perceptions are changing with 70% of respondents rating the costs of using an ECG core lab to be less than, or equal to, the cost of using paper. The study further highlights integrating data and workflows into a core lab can result in improved patient safety, increased productivity, allow faster database locks, enhanced service, greater satisfaction and potential cost savings, all of which are offered by a centralized approach. The study also examines the challenges of traditional decentralization methods.
Mike McKelvey, CEO at ERT, comments, "The study by the Tufts Center for the Study of Drug Development highlights the growing adoption of centralization as our sponsors are realizing the need for and benefits of a core ECG laboratory. Currently approximately 33% of clinical trials use a centralized core lab for cardiac safety; we anticipate that this will increase in the short- and long-term. Regulatory pressures and the necessity for better data quality and accuracy at a faster and more efficient speed are stimulating more rapid adoption. With more accurate, higher quality and standardized data at a lower cost, the positive benefits of centralization are now much better understood by industry professionals."