Breaking the Cardiac Safety Paradigm

John Blakely, Executive Vice President, Sales and Marketing for ERT, believes that approximately 33% of clinical trials requiring a cardiac safety component use a centralized core lab. As one of the companies that provides centralized cardiac safety assessment services, he’d like to see that number at around 100%—and all of it for ERT.

Arguably, the centralized rate at 33% is significant and the adoption rate as a whole is comparable with the problem that EDC faced a couple years ago. Paper. Couple that with other industry perceptions about the use of a centralized cardiac safety assessment provider, and there are some bridges to cross toward Blakely’s goal of 100% vision.

Paper paradigm
According to a study by the Tufts Center for the Study of Drug Development (CSDD), which provided an independent market analysis supported via an unrestricted grant by ERT, most investigative sites use paper for capturing ECG data. The “Mapping Adoption of Centralized Cardiac Safety Assessment” can be accessed here from the ERT Web site after registering.

In this report, the investigative sites that use paper only comprise 39%, paper with electronic transfer 24%, and electronic only 28%. However, there are two parallels at play in the centralized lab space: technology and actual use of a centralized vs. local lab model. Interviewees for the Tufts report believe that both the technology adoption rate will tip, like EDC recently did. And the use of a central service provider will also tip, a la what occurred with the centralization of blood and lab work used in clinical trials a few years ago.

Centralized vs. local
For sites responding to the study report, there was not a lot of disparity between satisfaction levels of working with a local or centralized cardiac safety assessment provider. Sites across the board believe that capturing ECG in any form and with any provider is moderately time consuming. Differences in accuracy and clarity favor the centralized provider. Cost is relatively equal and completion time favors the local lab.

In the end, however, it appears the sites feel they have little say in the matter of the provider and believe it is in the sponsors’ hands. But sites are reporting that sponsors are requesting central labs more, and over half of the respondents would prefer to work with a central ECG provider on their next trial.

Sponsors say
Blakely believes that sponsors are still under the notion that a centralized ECG provider is more expensive than the localized or internal process, primarily because of the hardware distribution involved. This perception was also reflected in the Tufts study, where sponsors said: “centralized ECG providers to be more expensive, yet they find that the accuracy and ease of use of central providers justify the costs.” Blakely disputes that the cost is more than a decentralized lab. He puts the cost per ECG at a centralized lab at $155 and a decentralized at $245, which for the sponsor using the centralized lab “is a fairly considerable savings.”

The drivers of using the digitally-optimized centralized lab are regulations…specifically, the ICH E14 guidance for thorough QT/QTc studies issued by FDA five years ago. The sponsors also like having a single project manager who is aware of the study, as well as a cardiologist who leads the central lab. But in the case of needing instant information on subject cardiac safety, the sponsor believes the investigator or local lab is the better point person.

Centralized Cardiac Safety 2.0
ERT released the Tufts CSDD report around the same time it introduced Centralized Cardiac Safety 2.0, a newly developed software technology within its best in class EXPERT operating platform. The goal was to use its Web portal technology to improve data quality, reduce investigator workload, improve the overall user experience at the investigative site, and give sponsors a Web window on the cardiac progress of their study, as well as the overall therapeutic program portfolios.

The technology allows for prepopulation of subject data so there are no errors, reducing downstream queries. With the solution, ERT also introduced the Mortara ELI PC under exclusive license. This will substantially reduce the ECG equipment and systems interface costs associated with a centralized approach. This small hand-held ECG collection device can make it easier for companies to adopt a centralized system as it interacts seamlessly and automatically with the central database, dramatically reducing both site workload and the volume of queries generated.

With its new solution, a major investment in its EXPERT operating platform, an armful of data from Tufts to backup its centralized cardiac safety gospel, and a new acquisition just announced last week, Blakely is certain that sponsors will embrace not only the centralized cardiac safety assessment model, but ERT as well.