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Applied Clinical Trials
In January, the Center for Business Intelligence (CBI) held its 4th Annual Cardiac Safety Assessment Summit in Washington, DC. Attendees to the event included Executive Directors and VPs (43%), Director level (51%), and 6% Managers/Associates largely from bio/pharmaceutical companies, with the balance from CROs, technology/service providers, and government or other.
Krista Martinko, Senior CRA at Otsuka Pharmaceutical attended the event and told Applied Clinical Trials that the event certainly provided a lot of information. “There were good speakers, and a good mix of different sides and angles toward cardiac safety.” Lawrence Satin, MD, FACC, Chief Medical Officer and Founder of Cardiocore, and co-chairman of the event, told Applied Clinical Trials the three topics that seemed to generate the most audience interest were:
• Cardiac Safety Testing in Oncology Drug Studies, Colette Strnadova, PhD, Senior Scientific Advisor, Therapeutic Products Directorate, Health Canada
• Assessment of Drugs that Affect Heart Rate, Gary Gintant, PhD, Senior Group Leader, Department Integrative Pharmacology, Abbott
• Clinical Validation of Automated ECG Readings a panel moderated by Philip Sager, MD, Vice President, Clinical Research, Gilead Sciences, Inc., and panelists: Ihor Gussak, MD, PhD, FACC, Vice President and Chief Medical Officer, NewCardio, Inc; Börje Darpö, MD, PhD, Pharmaceutical Consultant, Sweden; Sasha Latypova, Executive Vice President, iCardiac Technologies, Inc; Nenad Sarapa, MD, FCP, Head of Clinical Pharmacology-Oncology, Hoffmann-La Roche, and J. Rick Turner, PhD, Senior Director, Cardiovascular Safety, Quintiles ECG Services.
In particular, Martinko was interested in hearing what others were saying about FDA, and to learn where the FDA is going in regard to cardiac safety. “It’s important to know where FDA is going in regard to markers, which go toward getting the protocol design right.”
Satin compared the industry’s interest in cardiac safety four years ago—when the conference first convened—versus the industry’s current focus. “Four years ago the assessment of cardiac safety was centered on implementation of the ICH E14 Guidance (Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs, U.S. Department of Health and Human Services Food and Drug Administration, October 2005),” said Satin. “I would not classify the trends in cardiac safety today as changing rapidly since they all have their roots within the now venerable E14 Guidance. Today, we are applying the knowledge gained through the conduct and submission of numerous thorough QT trials to refine critical areas in protocol design and study implementation. Current discussions are also stimulated by varied interpretations of the Questions and Answers document the FDA published in late 2008 regarding E14, and by the continuous exploration of novel approaches.”
In the coming decade, Satin believes that cardiac safety will continue to expand beyond QT (electrical function), with cardiotoxicity assessment honing in on changes in cardiac physiology (mechanical function). “A key tool in the assessment of cardiac function is the echocardiogram. Centralized ECHO analysis is beginning to play a much greater role in the evaluation of type II anti-diabetic drugs and oncology therapies. Ambulatory blood pressure monitoring, which was once considered valuable only in assessment of anti-hypertensive treatments, is also playing a larger role in clinical trials across many therapeutic areas where the drug may cause increases in systolic and diastolic pressure. Although the biomarker of choice for cardiac ischemia and toxicity remains cardiac troponin, I believe that Pro-BNP will soon take on added importance as a predictor of congestive heart failure.”
In addition, Satin predicts a resurrgence in use of the Holter Bin methodology to evaluate drugs that alter heart rate. He bases this view on the fact that Holter Bin remains the only method that has successfully eliminated the misleading affect of significant heart rate changes, enabling drugs to achieve regulatory approval.
Editor’s Note: The Center for Business Intelligence (CBI) and Applied Clinical Trials are both owned by Advanstar Communications.