Talking Trials

Our leadership team’s perspective on the latest in CRO and clinical research breakthroughs.

By By Tomislav Babic, MD, PhD, Vice President, Neuroscience Franchise, Worldwide Clinical Trials,

The FDA approved Newron Pharmaceuticals, Zambon and US WorldMeds’ Xadago (safinamide) as an add-on therapy to levodopa/carbidopa for patients with Parkinson’s disease, the companies announced Tuesday, March 21, 2017.

The new drug received European marketing authorization in February 2015 for the treatment of Parkinson’s disease (PD). The approval covers the indication “safinamide as add-on therapy to levodopa alone or in combination with other Parkinson’s disease treatments” in mid-to late stage Parkinson’s disease patients.

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By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials,

While CVD has been the leading killer of Americans for decades, advances in biomedical research, improved emergency response systems and treatment and prevention efforts helped improve morbidity and mortality in recent years, although without eradicating the disease or the downstream morbidity and mortality. Between 2000 and 2011, the national heart-related mortality rate declined at an average of 3.7 percent per year, while stroke mortality declined at 4.5 percent per year. The bad news is that since then, further progress has stalled.

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By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials,

The rate of disease progression is dependent both on the primary pathology and the activity of the compensatory processes, the most important of these being neural, endocrine, renal and morphological. Most of these chronic compensatory processes, such as activation of the renin-angiotensin-aldosterone system (RAAS) and sympathetic nervous system, are believed to be harmful, although the increase in natriuretic peptides is believed to be a beneficial compensatory response.

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By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials,

In the 1990s the unmet medical need related to heart failure treatment was quite substantial. This unmet medical need was inversely proportional to the clinical trial size in previous years, using the conventional cardiovascular outcomes trial design. With the advent of the Angiotensin-Converting Enzyme Inhibitors (ACE-I) and aspirin (ASA) regimens as standard of care therapy, combined with the development of new diagnostic techniques, modern-day cardiac care units and cardiac catheterization/ revascularization techniques and strategies, there has been a reduction in this unmet medical need.

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By Jeff Zucker, M.S. Vice President, Feasibility, Recruitment Optimization, and Clinical Assessment Technologies,

The relationships between sponsors, clinical research organizations (CROs) and study sites present many challenges to a clinical trial. Indeed, the way in which these parties interact with each other can have a significant impact on the overall success of the study. With the increasing trend towards patient-centric trials, it is my opinion that sites and investigators are being somewhat forgotten in the process.

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By Toni Bransford, M.D., FACC Senior Medical Director, Medical & Scientific Affairs, Cardiovascular Disease, Worldwide Clinical Trials

 

Heart failure is a complex syndrome that had not seen new drugs receive approval for decades, which may be due in part to the cost and complexity of large cardiovascular outcome studies. However, in the last few years, the drug ivabradine was approved to reduce heart failure hospitalizations and sacubitril/valsartan was approved to reduce death and heart failure hospitalizations, and is currently recommended to replace angiotensin converting enzyme inhibitors as first line therapy in patients that tolerate it to reduce events.

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