Clinical Trial Spotlight
For over a decade, C5Research has combined scientific and clinical leadership in cardiovascular disease with operational excellence in Phase II-IV multicenter, clinical trial coordination. This strong foundation in cardiovascular trial coordination has expanded to include other therapeutic areas, capitalizing on the academic, scientific and medical expertise of Cleveland Clinic.
The BEACON (Best Expert Agreement for Care of Occult MI Nationally) Registry which aims to improve the process of care and heath outcomes of patients presenting with chest pain of suspected cardiac origin. W. Frank Peacock, MD, Venu Menon, MD, and Deepak L. Bhatt, MD, are national Principal Investigators. C5Research is performing Project Management and Statistical Analysis for the study.
PARTNER (PegylAted interferon Ribavirin and anti-TNfa Enhanced Response) study for the treatment of hepatitis C viral infection. The objective of the study is to investigate whether the addition of anti-TNF therapy with Infliximab (Remicade®) will increase the proportion of subjects attaining a sustained virological response, diminish the progression of fibrosis, and improve the safety profile in subjects receiving their first course of the standard therapy of Pegylated Interferon α-2b (Peg-Intron®) and Ribavirin (Rebetol®) for chronic hepatitis C (genotype 1). Nizar Zein, MD, is the national Principal Investigator and IND holder. Financial support for the project comes from Centocor, Inc. C5Research is performing Project Management.
STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) which compares advanced practice medical management versus advanced practice medical management plus bariatric surgery in type 2 diabetics. Philip Schauer, MD, is the Sponsor and national Principal Investigator of the study. C5Research’s roles include Project Management, Data Management, Carotid Initimal Medial Thickness measurement and Statistical Analysis.
W. Frank Peacock, MD, is a national Principal Investigator of The BEACON (Best Expert Agreement for Care of Occult MI Nationally) Registry which aims to improve the process of care and health outcomes of patients presenting with chest pain of suspected cardiac origin. Dr. Peacock is Vice-Chair in the Department of Emergency Medicine at Cleveland Clinic. Dr. Peacock has served in numerous hospital positions and is the Medical Director of Event Medicine at Cleveland Clinic. This program provides medical care for the major sports teams in Cleveland, including the Cleveland Browns, Indians and Cavaliers. Dr. Peacock received his medical degree from Wayne State University School of Medicine and completed his residency in emergency medicine at William Beaumont Hospital, Royal Oak, MI, where he joined the faculty. He has held faculty positions at the University of Michigan at Ann Arbor, the Ohio State University, MetroHealth Medical Center and joined Cleveland Clinic in 1994. He is the principal investigator for several international and national clinical trials, authored or co-authored more than 150 articles in leading medical journals and published extensively on heart failure and acute coronary syndromes. Dr. Peacock is Co-Editor of the book,
Cardiac Emergencies, and was most recently Editor of the texts,
Short Stay Management of Heart Failure and
Short Stay Management of Acute Coronary Syndromes. He serves on the Editorial Board for the journal
Congestive Heart Failure and is a member of the Board of Directors for the Society of Chest Pain Center
Philip Schauer, MD, is the Sponsor and national Principal Investigator of the STAMPEDE (Surgical Therapy And Medications Potentially Eradicate Diabetes Efficiently) study which compares advanced practice medical management versus advanced practice medical management plus bariatric surgery in type 2 diabetics. Dr. Schauer is Chief of Minimally Invasive General Surgery and Director of the Cleveland Clinic Bariatric and Metabolic Institute. He is also Professor of Surgery at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. After receiving his medical degree from the Baylor College of Medicine in Houston, Dr. Schauer completed his residency and internship in surgery at the University of Texas at San Antonio and a fellowship in laparoscopic surgery at Duke University Medical Center. Prior to joining Cleveland Clinic in 2004, Dr. Schauer served as Director of Endoscopic Surgery, Director of Bariatric Surgery and Director of the Mark Ravitch / Leon Hirsch Center for Minimally Invasive Surgery at the University of Pittsburgh Medical Center. Dr. Schauer's clinical interests include surgery for severe obesity, minimally invasive surgery (laparoscopic) and gastrointestinal surgery. He has performed more than 4,000 operations for severe obesity. His research interests include the pathophysiology of obesity and related diseases, physiologic effects of laparoscopic surgery on postoperative injury and recovery, and outcomes of laparoscopic management of obesity, gastrointestinal diseases and hernias. He is the principal investigator for several clinical trials and has authored or co-authored many articles in leading medical journals. He is the Associate Editor of
Surgery for Obesity and Related Diseases and is on the editorial board of three other surgical journals.
Nizar Zein, MD, is the Sponsor and national Principal Investigator of the PARTNER (PegylAted interferon Ribavirin and anti-TNfa Enhanced Response) study for the treatment of hepatitis C viral infection. Dr. Zein is holder of the Mikati Foundation Endowed Chair in Liver Diseases and Transplantation in the Digestive Disease Institute at Cleveland Clinic. He is also the Chief of Hepatology and the Medical Director of Liver Transplantation at the Cleveland Clinic. Dr. Zein’s specialty and research interests are focused on liver diseases, liver transplantation and viral hepatitis. Dr. Zein holds five patents relating to the treatment of liver diseases. He is the principal investigator for several clinical trials and has authored or co-authored more than 80 articles in leading medical journals. He is the Associate Editor of the
American Journal of Gastroenterology and the author of
Cleveland Clinic Guide in Liver Disorders. Dr. Zein received his medical degree from Tishreen University Medical School in Syria, completed residency training and an internship in internal medicine and pediatrics at the Medical College of Ohio Hospitals, a fellowship in adult and pediatric gastroenterology at Mayo Clinic and served on the medical staff at Mayo Clinic for several years. Dr. Zein joined Cleveland Clinic in 2002.