Centralized cardiac safety

How to achieve improved science at a lower cost with the most stakeholder convenience.

“A good core lab should perform the data management and cleaning as part of its standard contract.”
-John Blakeley

What are the main advantages of a centralized approach to cardiac safety against those of a more local nature?

John Blakeley. There are many advantages such as improved consistency, cleaner data and a single point of contact for the sponsor. However, when you really boil it down to the fundamental elements you are left with improved science at a lower cost with the most stakeholder convenience. Improved science because all ECGs in a program are centrally read in a repeatable consistent fashion. Cost is lowered because the centralized approach shifts a significant part of the spend from data management and cleaning to the central read process and hence reduces the overall spend considerably.

A good core lab should perform the data management and cleaning as part of its standard contract. It is the most convenient approach because you replace disparate multiple services and people with one single source thereby eliminating a lot of needless overhead. The standardization of equipment and process ensures waste is removed from many critical aspects of the process.

How does your project assurance methodology ensure the success of a client’s clinical study?

JB. Our methodology was developed over more than 6000 clinical trials across all phases of drug development. We discovered that every trial, regardless of phase, has certain elements that are crucial. Our approach allows us to drive a consistent repeatable approach to managing the crucial parts of projects, yet allows us to still recognize the subtle differences between studies and indeed amongst project teams. This overall standardization, allowing for small differences, has driven the consistent achievement of greater than 98 percent customer satisfaction in a business which today manages more than 700 live clinical trials at any point in time.

Why do more clinical trial sponsors not already utilize this centralized approach to cardiac safety?

JB. As an organization, we puzzled over this for a long time before we came to the conclusion that the prevailing attitude amongst sponsors was, “If it’s not broken, don’t fix it”, and this led to the decentralized or investigator-led approach being the accepted standard. However, in the current climate of tighter regulation and of smaller market size for new more targeted drugs, and the continued rise of the average cost of developing a new drug, we strongly believe sponsors are looking for ways to improve science and lower cost at the same time.

The sponsor community’s real need to address the quality issue and still be cognizant of top and bottom line cost pressures will ultimately prevail and sponsors will realize that it is possible to have the best science, which is universally recognized as the result of employing a centralized approach, at a highly competitive price.

What direction do you see centralized cardiac safety heading in the next few years?

JB. I believe there are tremendous parallels that can be drawn between the cardiac safety industry and the central blood lab business. There are different technical reasons why each will go centralized but the overriding issues of better science and cost control are almost identical. We are already seeing an increase in centralization of ECG analysis and over time I feel we will reach 80 percent to 90 percent centralized.

Biography

John Blakeley has been ERT’s Executive Vice President, Sales and Marketing since 2007. He previously served as the company’s Senior Vice President, International Operations and Sales, beginning September 2006.

He also served as Group Vice President, International Business Development from January 2005 to August 2006, and as Director of Business Development from May 2002 to December 2004. Prior to joining ERT, Blakeley was Managing Director of MediServe Medical UK Limited, a medical devices specialist.