The Collaborative Spine Research Foundation was created in November of 2011 by a partnership between the American Association of Neurosurgeons/Neurosurgery Research and Education Foundation and the Orthopaedic Research and Education Foundation to promote clinical research and unity among all spine surgeons. The CSRF board of directors includes an equal number of orthopedic surgeons and neurosurgeons, as well as one unaffiliated voting physician.
The organization's mission is to advance the science and practice of the highest quality spine care through collaborative funding and support of clinical research. Here, chairman of the board of directors James D. Heckman, MD, and secretary and treasurer of the organization Charles L. Branch, Jr., MD, discuss the organization's purpose and vision for the future.
Q: Why was it important for you to develop the Collaborative Spine Research Foundation?
Dr. James Heckman: The impetus was, and is funding more clinical research — more meaningful clinical research. In the past, most research was funded by industry, and in those studies the research requests have been generated by investigators. Investigators have an idea and they create a research proposal and then find a way to get it funded. In our organization, we are going to work with different stakeholders — physicians, specialty societies, patients, insurance companies — to figure out what important questions need to be addressed.
We want to create a research agenda to define the five to 10 really important clinical questions that need answers. We will incorporate those questions into our research agenda and then ask investigators to submit grant requests to specifically address these questions with the hope of finding answers.
Q: How does CSRF fit into the spine research field as a whole?
Dr. Charles Branch: Right now, federal funding of spine-related initiatives isn't very robust. Of the major spine-related initiatives in the past decade, the Spine Patient Outcome Research Trials study was funded by federal dollars, but no other significant, multispecialty, multi-institutional study was added to our evidence base. Industry also contributes research dollars, but these studies are often for product development or investigational device exemption under FDA supervision. They are generally focused on a specific product, device or technology.
We looked at the field and there are areas of spine care where high quality evidence is lacking. In essence, this is the space where Collaborative Spine hopes to add value. More multi-center research and clinical outcomes trials are needed that are structured to avoid the perception of being tainted — seen as industry-specific research initiatives. We see our Collaborative Spine approach as being an opportunity for developing a research agenda and for funding prospective research with a methodology that is missing in the current platform.
JH: Once the grants are funded, we hope to provide ongoing support, funding and supervision that will ensure successful completion of each project. Some endeavors start out well, but suffer from lack of clinical follow-up, oftentimes because they aren't funded adequately. This means the research falters after a year or two. Most of the questions we are addressing are going to be important clinical questions that need follow up for five to 10 years. We are going to put monitoring systems and support systems in place to make sure the follow-up data is robust and reliable.
Q: In general, what types of questions do you expect researchers to take on with this funding?
JH: The research will focus on common clinical conditions that have a substantial impact on the healthcare arena today. These questions will center around the frequency of disease and dollars spent.
CB: These projects should help us to identify which treatments and therapies offer the greatest value for patients, industry, payors, government and society in general. I think we are going to have studies that are structured for high level of evidence, which will allow for a great deal of confidence in the results.
Q: What impact will these studies have on the spine care industry?
JH: We hope the studies will provide guidance for physicians and insurers both. We crave guidelines that are based on evidence. Our dream would be that we would have guidance that everyone would accept as valid, and enable patients to be part of the decision-making process as well.
CB: Patients, payors and physicians want to do the best they can with their patients based on the research available. Right now, they don't have clear guidance for all conditions. When insurance companies aren't sure whether a certain procedure is effective, they create guidelines constraining physicians. There is an opportunity here to really provide clarity for appropriate spine care. If we can do that for a few major clinical conditions, we will have served society well.
Q: Where will the funding for research come from?
CB: We will be looking to industry to fund some of the investigation, but we are taking the money without any strings attached. When we receive funding commitments, we'll look at the research agenda and through a peer review process that is independent of the source of funding select which projects to fund. We will decide which proposals get the funding to deliver a good result. Regardless of the outcome, favorable or unfavorable, we'll support the researcher's findings.
I think the industry representatives are interested in this process because they know research needs to be more independent, well-designed and vetted through the peer-review process.
JH: We are hoping the insurance industry will provide support as well. We are also looking for foundations and other funding sources to step up. That is part of our solicitation process and hopefully we will have broader funding than just from industry.
Q: What will the vetting process look like for research proposals?
CB: The development of the research agenda will be a collaborative process among stakeholders, including surgeons and device-, pharmaceutical- and payor-industry representatives. We would like to have the broadest possible input so there is a sense that all groups have comparable needs. That's the research we aspire to develop.
JH: Vetting of the research proposals would occur through a peer-review process based primarily on scientific merit.
Q: What is your goal for the future of CSRF?
CB: Our goal is to enhance the quality of spine care. One of the perceived challenges we have is that we are competing with ongoing initiatives from spine societies. Our goal is not to compete with an individual spine society for industry support, but to accomplish something that an individual society or institution cannot accomplish and provide a path for societies or group investigators to accomplish their goals. Using Collaborative Spine as a funding vehicle that takes industry or other types of support and separates it from any kind of perceived influence allows investigators to generate quality research.
If we can add value to the evidence base, I think we will have done our job.
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Funding the Future of Spine Research: Q&A With Dr. Charles Branch & Dr. James Heckman of Collaborative Spine Research Foundation FeaturedWritten by Laura Miller | May 21, 2012
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