The CiPA Work Streams strive to make their projects and data collection processes as inclusive as possible. All additional related resources and data will be made publicly available here once they are completed and published. Check back periodically for new updates!
Myocyte Validation Study Data
Datasets from the Myocyte Valdiation Study Paper, Blinova et al, will be posted here soon!
Recommended Cardiac Ion Channel Protocols Under CiPA
As it is anticipated that nonclinical ion channel data will play an important role for regulatory decision-making in drug development programs, standardized protocols are recommended. This document contains detailed protocol recommendations for hERG, CaV1.2, and NaV1.5 channel studies. These recommendations are based on current knowledge, hence are expected to evolve over time. The document is time-stamped. We encourage you to verify with the Agency prior to initiating the studies to ensure that the document you have is up-to-date and to clarify questions including which protocol(s) to test for a specific drug. Access the protocols here.
In Silico Model Open Source Code
See the latest manuscript from the In Silico Work Stream here. The open source model code is available here:
Two new manuscripts were recently published in PLOS One: “Electrocardiographic Biomarkers for Detection of Drug-Induced Late Sodium Current Block” as well as the companion methods paper “Automated Algorithm for J-Tpeak and Tpeak-Tend Assessment of Drug-Induced Proarrhythmia Risk”. Download the PDFs on our Publications page.
The ECG signals and clinical information of the two clinical studies are available below. The source code of the automatic algorithm described in the methods paper is publicly available at https://github.com/FDA/ecglib
The CiPA initiative began following a workshop in July 2013 at the US FDA. The objective of the CIPA initiative is to engineer an assay for assessment of the proarrhythmic potential of new drugs that has improved specificity compared with the hERG assay plus Thorough QT study.
HESI can provide more details
about CiPA and CiPA workstreams.