One of the original goals of the CSRC was the development and scientific use of a large, centralized ECG repository, developed by the FDA with hardware and software support from Mortara Instrument. Data in the so-called ECG warehouse include proprietary digital ECG recordings from thorough QT (TQT) and related studies conducted in the course of drug development and post-market surveillance by industry sponsors.
The FDA’s ECG Warehouse currently holds more than 4 million ECGs that can be linked with descriptive study variables such as age, gender, and drug treatment group. The ECG Warehouse data are owned by the entities, generally pharmaceutical companies, that submit these data to the FDA. Release of the ECG data to the CSRC for public domain access by investigators, equipment manufacturers and algorithm developers was obtained with permission from the data owners as a collaborative effort of scientific goodwill on behalf of the public health.
In conjunction with the release of the ECG datasets to the CSRC, a Scientific Oversight Committee (SOC) within CSRC developed processes supporting the submission and evaluation of proposals for use of the released ECG data, which are also intended to foster collaboration within the scientific research community and across stakeholders. The initial focus of these protocols was to foster efforts to develop better surrogate markers for evaluation of electrophysiological safety, in particular algorithms that could more accurately, efficiently, or automatically detect QT prolongation signals from an active compound (such as moxifloxacin) compared to placebo exposure. To maintain an equitable and scientifically responsible governance of the ECG Warehouse, individual research protocols cleared by the SOC are approved by the CSRC Executive Committee before ECG data are released.
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Thorough QT Datasets