“The results of our evaluation suggest that many patients who are excluded from participation in clinical trials due to an elevated ECG machine-generated QTc measurement may actually have been eligible for study participation,"
October 26, 2015 (PRWEB) October 26, 2015 -- ERT, the leading cloud platform solutions provider delivering clinical and scientific innovation through its patient-centric data collection and intelligence solutions, today announced the findings of a study that may have important implications for subject recruitment and medication dosing in clinical oncology trials. The study was performed to compare machine-generated electrocardiogram (ECG) measurements (which rely on automated algorithms) versus high-precision ECG analysis generated through centralized cardiac safety measurement delivered by ERT.
“There is a general perception that ECG machine measurements of QTc are accurate and precise, but it is less widely known that ECG machine algorithms may significantly undermeasure or overmeasure the QT interval and heart rate, leading to errors in the derived value of QTc,” stated Dr. Robert Kleiman, Vice President, Cardiology and Chief Medical Officer, at ERT.“ Concurrently, many clinical trials of investigational oncologic agents utilize only ECG machine-generated measurements of QTc for inclusion/exclusion and dosing decisions, though their reliability in this setting has not been established.”
Dr. Kleiman is the author of ‘Benefits of Centralized ECG Reading in Clinical Oncology Studies,’ published in Therapeutic Innovation & Regulatory Science (TIRS), August 2015. The study can be found here.
The study was a retrospective, blinded evaluation of more than 270,000 consecutive ECGs collected from 299 clinical oncology trials. It compared decentralized ECG machine-generated QTc measurements collected by various devices and analyzed via automated, device-based algorithms with measurements obtained through ERT’s centralized Cardiac Safety services. The ERT centralized ECG measurements were collected by standardized ECG devices across investigative sites, analyzed via a semi-automated methodology and reviewed by trained cardiologists. The results of the study demonstrated large differences which may impact subject recruitment and retention, suggesting several implications for both investigators and sponsors of oncology clinical trials.
“The results of our evaluation suggest that many patients who are excluded from participation in clinical trials due to an elevated ECG machine-generated QTc measurement may actually have been eligible for study participation. This finding is especially important in oncology clinical trial subject recruitment, since on average only an estimated 3-6% of potential patients volunteer to participate as subjects,” commented Dr. Kleiman. “More important, by unnecessarily excluding potential subjects or withholding doses from patients who are actually still eligible to receive medication, this denies access to potentially lifesaving investigational therapies for patients who may have exhausted all conventional therapies in their battle against cancer.”
Dr. Kleiman will review the study’s findings during a complimentary webinar on December 10, 2015, “Maximize Oncology Trial Subject Recruitment & Help More Patients with Centralized ECG Reading.” Click here for additional information and to register.
For information on ERT’s Cardiac Safety solutions, including centralized ECG evaluation, visit https://www.ert.com/cardiac-safety.
ERT (http://www.ert.com) is a leading provider of high-quality patient safety and efficacy endpoint data collection solutions for use in clinical drug development. ERT delivers a combination of technology, services and clinical consulting that increase the accuracy and reliability of patient data and improve the widely deployed solutions in centralized Cardiac Safety, Respiratory, Suicide Risk Assessment, electronic Clinical Outcome Assessments (eCOA) – which includes patient-, clinician-, observer- and performance-reported outcomes – and cloud-based analytics and performance metrics. By efficiently integrating these solutions through a system built upon a scientific and regulatory foundation, ERT collects, analyzes and delivers safety and efficacy data critical to the approval, labeling and reimbursement of pharmaceutical products.
ERT is a global organization with headquarters in Philadelphia, PA and offices throughout the U.S., and in Germany, Japan, Switzerland and the U.K.
About Dr. Kleiman
Dr. Robert Kleiman is a board certified cardiologist and cardiac electrophysiologist who has performed research in both basic cellular electrophysiology as well as clinical electrophysiology. Dr. Kleiman completed his training at the University of Pennsylvania and was a member of a cardiology practice for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer and Vice President, Global Cardiology. His responsibilities include oversight of ERT’s cardiology services, consulting with external clients and managing overall satisfaction of ERT’s global customers, including all aspects of ERT’s solutions.