Streamlining data

By Amy Furlong, ERT

“Not only does centralization reduce inconsistencies that may occur from site to site, it alleviates sponsor/CRO and site burden”
-Amy Furlong

Increasing cardiac safety concerns have resulted in heightened regulatory scrutiny and the requirement for quality electrocardiogram (ECG) data to be provided in the early stages of drug development. Currently, a decentralized ECG study model is used in many clinical trials to monitor a new drug's effect on the electrical functions of the heart. A decentralized system involves ECG studies being carried out across multiple investigator sites using local ECG machines. However, this approach has a number of limitations including poor accuracy, consistency and efficiency of ECG data. A centralized approach has been found to overcome these shortcomings.

Centralizing the collection of quality ECG data, using digital ECG systems at a core laboratory, accelerates the analysis process. Using high resolution digital methodology allows for more dependable data to be generated as transcription and misinterpretation errors associated with a decentralized approach are eliminated. The improved reliability of data collected using this approach leads to significant cost reduction and reduces the need for retesting.

Some digital ECG systems offer the additional benefit of automatically checking for missing visits or changes in demography. A qualified cardiologist at the core laboratory evaluates each ECG, which ensures maximum data quality and consistency. Not only does centralization reduce inconsistencies that may occur from site to site, it alleviates laboratory and site workloads. Additionally, the centralization of ECG analysis eliminates unnecessary over read fees and reduces site technical fee payments. Using centralized equipment is an integral feature of a core laboratory, requiring no extra expenditure for machine rental.

To enable trial sponsors to take full advantage of these centralized ECG model benefits, innovative new instruments are necessary to provide improved accuracy, reliability, space efficiency and cost effectiveness. Conventional ECG machines can weigh between seven to 10lbs and be of substantial size, making them expensive to transport and store, as well as time consuming and difficult to prepare for use. Average rental costs of such machines generally vary between $100 and $150 per month.

Recent technological advancements will see the introduction of highly compact ECG instrumentation, providing full ECG functionality at a fraction of the size of traditional systems. Revolutionary new instruments that will substantially reduce the costs of centralization are being developed. These small hand-held devices are easier to maneuver and significantly less expensive to ship and store, making it easier for companies to adopt a centralized system. Integration of these new instruments into computer systems will enable information to be automatically downloaded before a trial, saving staff time and costs associated with programming correct algorithms and patient demographics. Utilization of this advanced instrumentation, with the process enhancements and reduced site and sponsor burden, will result in measurable cost savings.

Conventional ECG systems produce paper print-outs of key ECG data, which are transcribed in order for results to be analyzed. Transcription errors often occur, leading to inaccurate results and impacting the overall validity of trials. These new modern instruments work by directly uploading data onto the core laboratory computer system, eliminating transcription errors and increasing data accuracy.

Although not officially mandated in current legislation, regulators often request that digital ECG data are submitted to a central digital system, known as a data warehouse. All data stored on the system can then be accessed by regulators, facilitating and accelerating inspections. The latest centralized digital ECG systems enable clinical trial sponsors to easily comply with this requirement as they store all data centrally and simply transfer them to the data warehouse.

Advanced software platforms have also been developed to enable seamless integration of new instruments into existing computer systems. This is particularly beneficial in terms of both staff time and cost, especially to sponsors and CROs where the investigator site is not familiar with ECG systems. New centralized digital ECG solutions, which will feature the new instrumentation, demonstrate clear benefits over traditional decentralized methods, ensuring patient safety and regulatory compliance while reducing site burden and increasing accuracy, reliability and usability.    

For more information please visit www.ert.com.

For further press information please contact Fiona Robinson, The Scott Partnership, 1 Whiteside, Station Road, Holmes Chapel, Cheshire CW4 8AA, United Kingdom.

Amy Furlong is Executive Vice President of Cardiac Safety Operations. Amy holds a Bachelor of Science degree in Biology and a Master of Science degree in Quality Assurance and Regulatory Affairs from Temple University's School of Pharmacy. Amy has more than 10 years of clinical research experience specializing in regulatory compliance and computer system validation.