Q&A with Barbara Zupancic: How to Retain Patients in Cardiovascular (CV) Clinical Trials

patient retention in cardiovascular clinical trials
By Barbara Zupancic, Director of Global Patient Recruitment and Retention,

  In a January 2017 blog post, we noted that large international cardiovascular (CV) clinical trials are a better way to assess potential new treatments across many countries versus the alternative of separate smaller trials in each region. One of the more pressing challenges for clinical operations professionals who run these large trials is how to ensure patients who initially enroll in the studies continue to participate over the long term. For insights into how to retain patients in large outcome cardiovascular clinical trials, Talking Trials spoke with Worldwide’s Barbara Zupancic, Director, Global Patient Recruitment and Retention.

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Heart Disease and Stroke Research: the Burden of Cardiovascular Disease Today and Projections into 2035

Heart Disease and Stroke Research
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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Cardiovascular Research and Drug Development: What’s Next in Heart Failure Therapy?

Cardiovascular Research, Heart Failure Therapy
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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Heart Failure Clinical Trials and Alternative, Innovative Trial Design, Part 2: Pushing the Boulder Uphill

Heart Failure Clinical Trials
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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Heart Failure Clinical Research and Alternative, Innovative Trial Design, Part 1

Heart Failure Clinical Research

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. These approvals demonstrate that the health authorities are open to alternative, innovative clinical trial designs that don’t circumvent safety and are still able to show efficacy. Novel endpoints are one way to achieve this goal without increasing overall clinical research costs for pharma companies and cardiovascular contract research organizations (CROs).  

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Five Emerging Trends within Cardiovascular Research

Cardiovascular Research
By Michael F Murphy MD, PhD
Toni Bransford, MD, FACC
Eteri Tsetskhladze MD, PhD
William L Slone, PhD
deMauri Mackie PhD,

Over the past 50 years, dramatic changes in the treatment of cardiovascular disease, accompanied by marked declines in morbidity and mortality have occurred. Nonetheless, cardiovascular disease remains the leading cause of death and disability in the world. With increasingly permissive science providing new insights into pathophysiology, innovative drug discovery methods now engage more specific targets of cardiopathophysiology and drug development occurs in a highly internationalized environment.

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