A Heart-Pounding Development in QT Assessment
January 6,2015 Lorraine Rusch

 

Word cloud heart disease related in shape of heart organIn a recent blog we told you about a new, exciting development in cardiovascular monitoring technology that would allow for earlier assessment of potential drug-induced proarrhthymia, currently evaluated under the 2005 FDA Thorough QT (TQT) Guidance. On Friday, December 12, 2014, the news of a technique for reliably assessing QT/QTc from data captured during routinely conducted Phase I studies was shared during an FDA-hosted Cardiac Safety Research Consortium meeting with attendees from the regulatory, biopharma and medical communities.

As announced in the Wall Street Journal article on December 18th, “iCardiac Technologies, Inc., a provider of cardiac safety assessment services, in the fall completed a study in collaboration with the U.S. Food and Drug Administration that demonstrated cardiac toxicity in drugs can be detected much earlier in the development process than previously thought by medical professionals.”

Over the last decade, QTc studies have been conducted for almost all New Chemical Entities (NCEs) exhibiting systemic exposure. At a cost of approximately $2 to 4 million per study, TQT represents a significant investment and development risk considering a positive finding can result in onerous late-stage or post-approval commitments for safety monitoring. It can also completely end the development of the compound.

The Cardiac Safety Research Consortium-FDA study demonstrated that the new cardiac technology allows this assessment to be conducted as early as during the First-in-Human (FIH) dosing study. These studies are typically administered to healthy normal volunteers in single doses to small cohorts in an ascending manner with the objectives of evaluating safety, tolerability, pharmacokinetics and potential .dosing regimen for further studies in patient populations.

Medical monitor in the operating room.

Newer and more rigorous modeling techniques are being utilized to maximize the power of smaller sized studies with increased data collection and analysis. The methodology includes a significant increase in ECG data evaluation, use of improved algorithms for cardiac assessment and careful analysis of compound systemic exposure to create a powerful combination of maximal data points in a smaller clinical trial performed as part of a required FIH study.

The question of the FDA acceptance of this new paradigm was addressed frankly by Dr. Norman Stockbridge, a director in the Division of Cardiovascular and Renal Products at the FDA's Center for Drug Evaluation and Research. Dr Stockbridge stated to the Wall Street Journal that "if a pharmaceutical company comes to me with results using this type of a methodology, and the study is well conducted with high quality electrocardiogram data collection and analysis, I'm ready to recommend its use in regulatory decision making today."

This clear pathway forward is indeed a revolutionary attitude, freeing pharmaceutical companies to evaluate their potential therapies earlier in development, provide more product valuation for companies looking for further investment or partnering, and most importantly create an early translation of preclinical cardiac safety studies into viable human data and a safety platform for further clinical trials.

logoVince & Associates Clinical Research is proud to announce that we will become the first clinical research unit to be a Certified Site byiCardiac, with joint studies initiating in 2015. This certification process by one of the co-author companies of the CSRC-FDA paper has incorporated documented on-site training in the cardiac monitoring activities of physicians, research nurses and paramedics at Vince & Associates and iCardiac technologists.

Stethoscope Heart ShapeAs a certified partner, Vince & Associates Clinical Research is well positioned to support the needs of clients looking to incorporate TQT assessment into their early clinical studies. The expertise of the technical staff at the clinical pharmacology site often makes the difference between a successful (i.e., negative finding) study and a positive finding during this pivotal assessment phase.

This certification process by iCardiac definitively identifies Vince & Associates as able to execute ECG readings that are interpretable, with all data points, and also clearly demonstrate placebo are crucial to fulfilling the study objectives. The additional parameter of cardiac monitoring requires the technical training to competently acquire clean, quality data that can then be analyzed in tandem with the pharmacokinetic exposure data.

The expertise of the technical staff at Vince & Associates’ state-of-the-art clinical pharmacology campus is key for the successful completion of these complex cardiac safety studies. Our unique focus on early phase clinical development means that our facility and staff are designed to conduct studies that are complex and have additional safety parameters so as to mitigate risk.

cardiac header

Join us at the upcoming Cardiac Safety Symposium to discuss this new paradigm and hear from co-authors of the IQ-CSRC paper discussing this new methodology.

 

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