West Virginia’s Marshall University MCRC Getting on the Global Clinical Trials Map

West Virginia’s Marshall University MCRC Getting on the Global Clinical Trials Map

Investigators from West Virginia’s Marshall Clinical Research Center (MCRC) have received some national attention thanks to their participation in the multi-national, large-scale HEALTH clinical trial, via the Marshall University Joan C. Edwards School of Medicine. The global clinical trial seeks to establish a standard of care for surgical handling of hip fracture surgeries.

The Study

The School’s department of orthopedic surgery received recognition for its participation in a multi-national, multi-year, and multi-site study called, “Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults with Displaced Hip Fractures (HEALTH)

The study deals with hip fracture, an injury that can impair independence and quality of life and which occurs in about 280,000 Americans and 36,000 Canadians per year. By 2040 alone, hip fracture-related health care costs will total $9.8 billion in the U.S. and $650 million in Canada. The research was established in part to help establish optimal guidelines for the surgical handling of this injury. In one type of hip fracture, known as displaced femoral neck fracture, the standard of care has been to replace the hip. Patients undergoing this hip replacement may receive either A) total hip replacement (the head of the femur and the hip joint socket are replaced) or B) partial hip replacement (only the head of the femur is replaced). The HEALTH study compares the two different hip replacement procedures to determine which one results in superior outcomes after surgery in adults aged 50 and older.

The study started in 2009 and was completed in May 2009.  Sponsored by McMaster University in Canada, sponsor collaborators included the Canadian Institutes of Health Research (CHIR)National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Hamilton Health Sciences Corporation, ZonMw: The Netherlands Organization for Health Research and Development and Sophies Minde Ortopedi AS. The final results were published in the

Marshall University Tops Sites in North America

MCRC was one of 80 sites in 10 countries. According to a recent news release from Marshall University, MCRC topped the list of sites with the highest rate of patient recruitment in North America. A total of 1,495 patients were actually enrolled in the study (1,501 were initially targeted in the protocol).

Study Results

Published in the prestigious New England Journal of Medicine, the investigators and sponsors concluded that no functional outcome differences were present in the two groups.

Franklin D. Shuler, MD, PhD, professor and vice chair of research at Marshall University’s department of orthopedic surgery reported “Participation in the Level I HEALTH clinical trial with publication in the prestigious New England Journal of Medicine is a landmark project for our department and the Marshall School of Medicine.” Dr. Franklin continued, “The published results helped clarify the standard of care for hip fracture management.”

Marshall University MCRC Participating in other Major Clinical Research

Marshall University School of Medicine’s MCRC has been quite active in other major clinical trials, such as the Phase III AURORA study through Allergan for non-alcoholic steatohepatitis (NASH); a Premia Spine study evaluating the TOPS™ System for spinal surgery; meningococcal vaccine and maternal RSV vaccine studies through Pfizer, a chronic migraine study through Amgen and a Parkinson’s study through Enterin.

Marshall University, through its proactive and growing clinical trial participation, first and foremost contributes the ongoing introduction of cutting-edge treatment options to West Virginia patients but also contributes to published knowledge ultimately serving to improve overall standard of care for patients, reports Uma Sundaram, MD, vice dean of research and graduate education at the school of medicine.

Research at Marshall: More Translational & More Interdisciplinary

Marshall University School of Medicine Research recently reorganized the Office of Research and Graduate Education.  Not only including the PhD, MD/PhD, Research MS and Medical Sciences MS, the new MS in Clinical and Translational Science degree is housed in the office. Moreover, they are redesigning the curriculum to better prepare students to be more competitive in research that has become more translational and interdisciplinary.

Research as a Care Option for Tristate Metro Community

The MCRC promotes clinical and translational research in order to provide advance care that is currently unavailable for the residents of the Tristate Metro Community (West Virginia, Southern Ohio and Eastern Kentucky). All of their clinical trials adhere to their vision as well as guiding principles

MCRC has been organized as a centralized unit within the Office of Research and Graduate Education at Joan C. Edwards School of Medicine (JCESOM). The centralized CRC better coordinates and promotes all clinical research at JCESOM. The primary office consists of the Vice Dean for Research and Graduate Education, Medical Director of the CRC, Director of Clinical Informatics and support staff (all listed below). The CRC is located in the Charles H. McKown Translational Genomic Research Institute at Marshall University Medical Center in Cabell Huntington Hospital.

Call to Action: Interested in partnering with Marshall University School of Medicine Marshall Clinical Research Center? See link to staff.