ERT Demonstrates Patient Safety Expertise in Clinical Trials with New Knowledge Series of Papers
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The papers are now available to download from the company’s website - www.ERT.com.
This new Knowledge Series of papers focuses on two of ERT’s patient safety solutions, the centralized collection and analysis of ECG data to ensure cardiac safety in clinical trials and the use of electronic patient reported outcomes (ePRO) for suicidality monitoring in clinical trials.
ERT’s cardiac safety solutions offer a centralized method of accurate ECG data collection and analysis. Its centralized core laboratory enables the real-time collection of consistent and reliable ECG data - a critical element in the accurate assessment of the cardiac effect of new drugs. Centralization not only minimizes inconsistencies that may occur from site to site but also reduces clients’ workloads. ERT simplifies ECG data management and analysis to provide on-demand, real-time access to ECG study data.
Clinical trials can be delayed due to slow enrollment, problems with paper documentation and the inability to monitor sensitive patient data, costing sponsors millions of dollars. ERT’s ePRO solutions enable clients to capture sensitive findings directly from their patients, a process that is critical to proving the efficacy of their compound and its effects on patient safety. ERT offers a quick and easy, phone-based, voice-response solution, which is designed and optimized to help its clients collect clinically valid and sensitive data directly from participating patients.
John Blakeley, Executive Vice President of ERT, comments, “We are pleased to be able to offer these informative papers to the scientific community as part of the new ERT Knowledge Series. We intend to expand upon these in the future, adding more innovative papers to the series on hot industry topics and sharing our expert knowledge on products and services for clinical trials.”
Jeffrey Litwin’s paper on ECG centralization examines how central core laboratories are playing an increasingly important role in cardiac safety during clinical trials. In recent years, cardiac safety concerns have been cited as the most frequent reason for many new drugs and compounds being withdrawn from the market or receiving a refusal of regulatory approval. This paper demonstrates the importance of rigorous and accurate ECG data collection and analysis during clinical trials, discussing the benefits of a centralized approach to ECG collection.
A second paper, entitled, “Is Centralization the Future for Cardiac Safety in Clinical Trials?”, authored by Amy Furlong, looks at the importance of accurate and reliable ECG data collection and analysis. This paper expands on Jeffrey Litwin’s paper to look at the future of cardiac safety in clinical trials. It covers the difficulty of estimating the true costs of cardiac safety, arguing the improved accuracy of digitally generated ECG data makes the centralized approach a more cost-effective option by reducing the need for retesting. It also discusses the need for innovative new instruments and the benefits gained by the introduction of highly compact ECG systems.
The third paper in the series, written by Michael Federico, investigates the increased risk of suicidal behaviors in patients as a result of medications. The paper examines how ePRO plays an increasingly important role in suicidality monitoring in clinical trials. It contrasts traditional face-to-face and paper-based methods of suicidality monitoring with electronic initiatives.