- November 8, 2019
- Organized By:
This on-demand webinar is FREE.
This webinar provides an overview of the new technical specifications document, Submitting Clinical Trial Datasets for Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential of Drugs, released in June 2019.
FDA discusses how to format datasets to support by-time, concentration-QT, and categorical outlier analyses in accordance with ICH E14 guidelines. Examples will include designs commonly used in thorough QT studies as well as other designs generally used in early phase clinical studies.
The guidance was developed to streamline the review process of clinical QT studies by specifying a set of technical specifications for analysis datasets to facilitate automatic validation and analysis of the study data.
- Data managers preparing analysis datasets from thorough QT (TQT) studies or other clinical studies
- Clinical analysts assessing drug-induced effects in QT interval and other ECG intervals.
- Clinical research organizations and consultants focused on clinical data and analyses used to assess the potential of a drug to prolongation QT and other ECG intervals
- Regulatory affairs professionals who submit study reports and datasets to fulfill ICH E14 requirements in INDs/NDAs
- Researchers and healthcare professionals specializing in drug-induced QT prolongation
- Assessment of the drug effect in QT interval (and other ECG intervals) in dedicated thorough QT and early phase clinical studies and challenges with how data are currently submitted
- Overview of the QT Studies Technical Specifications Document
- Formatting study data for crossover, parallel and other study designs common in QT assessment using the QT Studies Technical Specifications Document
- Standardized analysis using datasets formatted following the QT Studies Technical Specifications Document
- Distinguish the main components of the QT Studies Technical Specifications Document (TSD) for datasets from QT/ECG studies and their relationship with how data are currently submitted
- Create QT Studies TSD compliant datasets from the study raw data sources (e.g., from SDTM to ADSL, ADPC, and ADEG)
- Demonstrate how to use datasets following the QT Studies TSD to perform by-time, concentration-QT and categorical outlier analyses in accordance with the ICH E14 guideline
Jose Vicente, PhD
Division of Cardiovascular and Renal Products| Office of New Drugs | CDER | FDA
- Submitting Clinical Trial Datasets for Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential of Drugs (Technical Specifications Document)
- ICH E14 guidance
- FDA’s QT Interdisciplinary Review Team website
- You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2018-D-1216
For questions concerning the webinar, please contact CDER SBIA at: CDERSBIA@fda.hhs.gov or call (866) 405-5367 | (301) 796-6707
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|Technical Specification for Submitting Data for QT Studies||pdf (804.39 KB)|