St. Louis – Timothy Callahan, Ph.D., chief medical officer of Biomedical Systems, a premier, global provider of centralized diagnostic services, spoke on “Cardiac Safety in the Post E14 Era” at a recent seminar in Suzhou, China.
That information and his recent article in Applied Clinical Trials shed light on the future of QT in clinical trials in response to the FDA’s indication that the thorough QT trial (TQT) will need to be replaced. The ICH guidance document E14, originally endorsed in 2005, covers the TQT trial.
“Regulatory agencies now expect a more broad-based cardiac safety dossier for new chemical entities,” Callahan said, speaking at the 12th Annual Congress of International Drug Discovery Science & Technology (IDDST). “This will include both preclinical and clinical data to include variables such as blood pressure, heart rate and other ECG parameters beyond the QT interval.”
An expert in diagnostic testing, Callahan suggests that shifting the burden of proof from a TQT trial to a combination of preclinical data and early phase human data might be beneficial. Callahan has more than 25 years of clinical research experience and has co-authored two patents in QT interval analysis and one in dynamical systems modeling of ECG data.
For more information about ensuring cardiac safety and other diagnostic testing, email Biomedical Systems at [email protected] or call 800.877.6334 or +32.2.661.2070.