On 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.
Over the last decade, QT 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, QT studies represent 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.
The question of the FDA acceptance of this new paradigm was addressed by Dr. Norman Stockbridge, a director in the Division of Cardiovascular and Renal Products at the FDA. Stockbridge told The Wall Street Journal that “if a pharmaceutical company comes to [him] with results using this type of a methodology, and the study is well conducted with high-quality electrocardiogram data collection and analysis, [he is] ready to recommend its use in regulatory decision making today.”
This clear pathway forward is 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.
Written by Guest Writer Lorraine Rusch. Dr. Rusch is the Vice President of Business Development at Vince & Associates Clinical Research, providing a consultative service tailored to the needs of biotechnology and pharma clients. She focuses on the incorporation of cutting edge approaches and technologies in clinical pharmacology research and has been responsible for the creation of viable strategies for clients interested in achieving early clinical assessment of cardiac safety of their new chemical entities.
This article was reprinted from Volume 22, Issue 08, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact email@example.com. Subscribe >>