SpineMark CRO Management a SpineMark (San Diego) subsidiary reported collaborating with Los Angeles and Denver-area physicians to create the nation's first multidisciplinary, multisite Spine Research Organizations (SRO), to unite the regions' leading spine experts under one organization.
"It's a one-stop shopping center of spinal clinical research, if you will," Marcy Rogers, president/CEO of SpineMark told Medical Device Daily.
The SpineMark SROs will provide patients in their respective communities with access to the most advanced spine care therapies under research today, while offering the participating physicians and hospitals an opportunity to be involved in a network to conduct their research.
SpineMark will provide the necessary tech and help to navigate setting up researchers seeking FDA approval for innovations.
The SpineMark SROs, which include surgical specialists, interventional pain specialists and conservative care physicians, will provide a seamless, integrated path of care for patients needing spine treatment. SpineMark will work with medical device and pharmaceutical companies to recruit for FDA trials, coordinate with the SRO and provide quality assurance, as well as appropriate staff infrastructure for trial protocols, policies and procedures.
"Many of us have wanted to offer our patients greater treatment options, but we've been limited by the amount of infrastructure necessary to participate in large, national trials," said Robert Bess, MD, an orthopedic spine surgeon and co-founder of the SpineMark SRO of Denver. "By partnering with SpineMark, we are able to provide patients with the best of all worlds — access to community practices that can provide quality, personalized care coupled with the clinical trial opportunities of larger facilities."
Los Angeles and Denver are the first of several cities nationwide that are working with SpineMark to create regional organizations.
The first sites for care in the SpineMark SRO of Denver are the Littleton Adventist Hospital (Littleton, Colorado) and the Lone Tree Ambulatory Surgery Center (LoneTree, Colorado).
"We're going to have 35 sites [in all]," Rogers told MDD. "We have eight sites already operational and will have 15 [more] by the end of the year." She said that plans call for the network to eventually expand outside the U.S.
Rogers said that it should be noted that SpineMark doesn't have any stock options in this.
"There has been so much scrutiny between doctors and med-tech companies as of late," she said referring to a string of The New York Times articles chronicling the eroding trust between doctors and patients. "But this [initiative] removes all that ... it is purely for research. "This is a new model in spine care research that allows us to bring the best clinicians in spine care under one umbrella organization so that patients have the benefit of receiving cutting-edge treatments from recognized physician and healthcare provider leaders who may want to expand their capacity to participate in more FDA trials."
"Specialized treatments for spine are being developed and launched at a rapid pace, and research and physician specialization in the field of spinal medicine have dramatically accelerated in the last 10 years," Rogers added. "We expect the value of our SRO model to hasten the availability of new therapies and provide infrastructure to spine specialists to support the establishment of SpineMark SROs across the United States and even globally."
In conjunction with the launch of the organizations, Dr. Bess and Dr. John Prall, a neurosurgeon, have launched the organization's first clinical trial evaluating StabiliMax, a device from Applied Spine Technologies (New Haven, Connecticut).
StabiliMax is designed to provide dynamic stabilization of the spine without fusion in patients undergoing decompression surgery for the treatment of spinal stenosis.
Nearly 80% of Americans will experience back pain during their lifetime, making it one of the most common reasons for missed work and the second most common reason for visits to the doctor's office, outnumbered only by upper-respiratory infections.
Established in 2006, SpineMark CRO Management has a network of seven spine research sites, including the SpineMark CRO at TBI, and is currently working with more than 15 sponsors on FDA clinical trial support.
In another new venture: The National Kidney Foundation (New York) and Amgen (Thousand Oaks, California) reported a new initiative, the Kidney Early Evaluation Program (KEEP), to provide important data to help communities address the growing prevalence of chronic kidney disease (CKD).
The initiative introduces a participant follow-up or "longitudinal" component to the National Kidney Foundation's KEEP effort, strengthening the comprehensive, free kidney disease screening program.
The program is made possible by an educational grant from Amgen, KEEP's primary sponsor.
Offered at community-based locations across the country, KEEP provides health risk appraisals to assess individuals' kidney function and key risk factors for the disease, including high blood pressure and diabetes. The appraisals are based on blood and urine testing as well as on-site physician consultations.
The program is expected to screen about 40,000 people in 2008 and recently screened its 100,000th participant since its inception in 2000.