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Improvements in data quality and data capture and reduced workload for sponsors and sites are evident.
Cardiac safety is cited as the most frequent reason for drug withdrawals from the market, labeling changes, delay or refusal of regulatory approval. This places great importance on the accurate collection, analysis, and interpretation of ECG data during clinical trials.
The FDA implemented the ICH E14 guidance document to provide recommendations to sponsors on the design, conduct, analysis, and interpretation of clinical studies that assess the cardiac effects of new drugs. The guidelines recommend that a Thorough ECG Trial (TET) should be utilized and if any cardiac concerns are raised, Phase III trials will then require more robust or intense ECG collection.
Traditional ECG data gathering methods use a decentralized model. A decentralized system is typically carried out across multiple investigator sites using local ECG machines with paper print-out assessments. Using different model machines at different sites means that data is often inconsistent as not all machines use the same methods for calculating the resultant data. Also, different site investigators' interpretation of the results and transcription errors can create further inconsistencies in ECG results.
A centralized approach uses digital ECGs and a core laboratory, handling the work carried out by sponsors, CROs, and individual monitoring sites. The core lab typically provides all ECG equipment to sites ensuring complete consistency throughout the trial, a faster reading process, and elimination of transcription and misinterpretation errors. Each ECG is evaluated by a qualified cardiologist to ensure data quality and integrity.
Key costs associated with centralized ECG trials are the rental, storage, and shipping of ECG machines to investigator sites. A typical ECG machine can weigh between seven to 10 lbs and be of substantial size, with average rental costs varying between $100 and $150 per month. Reducing the acquisition fee, which includes the rental of ECG instrumentation, is one way of reducing costs. Using centralized equipment is an integral feature of a core laboratory and, therefore, the sponsor should not pay extra for machine rentals.
The majority of ECGs performed in trials worldwide are still using a decentralized system. A common misconception is that centralized systems carry substantially more cost than the traditional decentralized approach. However, the increased usability, reliability, accuracy, and reduced investigator burden of a centralized ECG system are often overlooked.
As demand for improved accuracy and reliability increases, new highly compact instrumentation is being explored that will substantially reduce transport and storage costs yet provide full ECG functionality in a hand-held unit.
Integration of ECG instrumentation into existing computer systems allows key data to be automatically downloaded before a trial, saving staff time and costs associated with set-up and with programming correct algorithms and patient demographics before readings are taken.
It remains a challenge for core labs to fully demonstrate to sponsors the added value brought about by centralization as well as the cost-savings realized through the complete study management process.
However, innovative new instrumentation will help clinical trial sponsors ensure future patient safety and regulatory compliance by reducing site burden, increasing accuracy, reliability, usability, and accessibility to quality results.
Amy Furlong Executive Vice President Cardiac Safety Operations, ERT www.ert.com