eResearch Technology (eRT), the US-based provider of centralised electrocardiographic, eClinical technology and electronic patient-reported outcomes services, has hit a milestone with the completion of its 100th Thorough QT (TQT) study.

Usually conducted in the earlier phases of drug development, TQT studies are cardiac safety trials that look at a drug’s impact on cardiac repolarisation by identifying and quantifying any prolongation of the QT/QTc interval. As eRT points out, QT has been identified as a crucial cardiac safety marker and QTc prolongation is a known surrogate for assessing the cardiac safety risk of a new drug.

According to the most recent regulatory guidance, from the US Food and Drug Administration and, at global level, the International Conference on Harmonisation’s October 2005 E14 guideline on the clinical evaluation of QT/QTc interval prolongation (Step 5), the development of most drug candidates should include a QT study conducted with standardised and validated digital equipment, designated cardiologists, consistent measurement methodology, and digital data collection, storage and submission in XML format, the company notes.

eRT began performing Thorough QT/QTc trials in line with the E14 guidance as early as in 2002. “Since then, the pharma industry has grown to understand the necessity of this type of study to preserve cardiac safety and mitigate the repolarisation effects of new drugs,” commented Dr Jeffrey Litwin, the company’s chief medical officer. “We have now completed 100 such trials, working with sponsors of all sizes to construct and conduct these studies in a scientifically valid manner, providing the scientific and operational expertise they need for this important aspect of drug development.”

Another recent indicator of this trend was the cardiac safety collaboration announced last month by Quintiles Transnational and Bio-Kinetic Clinical Applications, the early-phase clinical research unit acquired in February by US-based contract research organisation QPS. The new partners will provide a full-service, single-point solution for TQT studies, from the first regulatory strategy through to generation of the final clinical study report.

Dr Michael McKelvey, president and chief executive officer of eRT, said lack of robust, high-quality cardiac safety data “remains the most significant barrier to final drug approval”.