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The Need for Research Training in Orthopaedic Residency Education

Anderson, Robert, W

Clinical Orthopaedics and Related Research: August 2006 - Volume 449 - Issue - p 81-88
doi: 10.1097/01.blo.0000229290.14098.2d
SECTION I: SYMPOSIUM I: C. T. Brighton/ABJS Workshop on Orthopaedic Education

Orthopaedic surgery residents should be exposed during their clinical training to the processes of creativity and innovation that are the basis of research. The definition of a research experience for surgery residents should be broad and include not only traditional bench research in a basic science environment but also translational and clinical research to move innovation from bench to bedside and validate its value in a scientific manner. Additionally, there are enormous opportunities for surgeons to study healthcare delivery and policy and to develop new approaches to educating colleagues, other medical personnel, and patients. The question that must be addressed is how can the knowledge and human resources residing in orthopaedic surgery best be used to meet the challenges future residents will face as healthcare undergoes profound changes? How these issues are managed in a rapidly changing environment is the critical issue and the challenge faced by surgical training programs wishing to remain viable and provide trainees with the opportunity to adapt and be successful in the future. What is state of the art today will not be tomorrow and unless trainees are encouraged and taught to be creative and innovative they risk becoming surgical dinosaurs.

From the Department of Surgery, Duke University School of Medicine, Durham, NC.

The author certifies that he has no commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

Correspondence to: Robert W. Anderson, MD, Box 2636 Medical Sciences Research Building, Duke University Medical Center, Durham, NC 27710. Phone: 919-681-2602; E-mail:

Traditionally, academic departments and divisions of surgery in all specialties have considered it their mission to create an optimal environment for clinical and investigative surgery for students, residents, and faculty. The ability to balance the clinical care role of the department with education, research, and professional service has depended in part on generating clinical funds to support the efforts of the faculty, staff and the academic component of the department. Through the 1970s and 1980s, abundant clinical dollars were generated by most departments of surgery, and they had little problem retaining a portion of the net revenue to support surgical research programs. Many of these research efforts, however, were poorly developed and had little focus. In many instances, the work was conducted by surgeons with little training in the scientific method but who were told by enthusiastic chairpersons and deans they needed to conduct some research for promotion. Residents were delegated to faculty members and assigned a project that in many instances consisted of performing surgical procedures on animals and studying physiology (ie, pulmonary, gastrointestinal, cardiovascular, musculoskeletal). However unproductive this experience might have been scientifically, it served the purpose of exposing the resident to research. Dr. Julius Comroe, the late director of the Cardiovascular Research Institute at the University of California, stated the important thing was to expose the student/resident to research no matter what the project might be, as this may be the only way some will enter a research career in the basic or clinical sciences.2

As patterns of healthcare delivery have changed, with decreasing reimbursement for clinical services and decreasing subsidization by state and federal sources, the commitment to academic and scholarly productivity has diminished at many institutions. The emphasis has been on providing clinical training with less commitment to fostering research endeavors. Important changes in the financing of healthcare have led to a diminishing pool of clinical dollars at virtually every medical center. At the same time, traditional sources of surgical research funding, such as the National Institutes of Health (NIH), foundations developed by specialty societies, and disease-oriented organizations, such as the American Cancer Society, March of Dimes and American Heart Association, have become increasingly more competitive in obtaining research funding. Surgical research has been less well supported than in the past because of its traditional emphasis on intact physiology as opposed to the rapidly developing areas of molecular biology, genetics, and immunology. Although the NIH level of funding has doubled in the past decade, it has effectively dropped over the past 2 years while grant applications have increased 20% to 30% per year. The competitive nature of obtaining grants with an emphasis on basic science and biodefense has made it difficult for surgical investigators with extensive clinical commitments to continue to be competitive in this funding arena. As the number of surgeon-scientists has dropped in recent years, there has been a similar drop in doctor of philosophy scientists in clinical departments.6,8 These core scientists have had to become more focused on basic research to stay funded, sometimes to the exclusion of meaningful involvement with their clinical colleagues. Many institutions began to seriously question the value of surgical research while others have taken the approach that the departments made enough money to support their own research efforts.

At the same time, residents training in the surgical specialties began to doubt the value of mandatory time in the research laboratory as they viewed their own precarious financial situation with mounting debts from medical school and declining reimbursements for their clinical effort as they began to practice their specialty. Surgical trainees opted for programs with a clinical orientation and in many cases chose to pursue fellowships in various areas of clinical specialization after their residency training.

My experience in training residents in general and cardiothoracic surgery extends over more than three decades, but I believe research holds relevance for orthopaedic residency education. I am the first to admit my bias, which is based on my own experience in training under Dr. David Sabiston at Duke and serving on the faculty of three institutions, all of which placed a great emphasis in all of the surgical training programs on the value of a research experience for residents. Duke, under Dr. Sabiston's leadership, maintained a firm commitment to providing a minimum of 2 full years of research experience for every resident who entered the categorical general surgery training program. This commitment was maintained during my 9-year tenure as chairman and continues under my successor, Dr. Jacobs. It is obvious that every resident who applies to the program is fully aware of this requirement and we have therefore tended to attract people who are seriously considering a career in academic surgery. In reviewing the results of our training program at Duke, several things are apparent. Since 1964, when Dr. Sabiston arrived, 244 residents have completed the general surgery training program including at least 2 years of fulltime research experience. Approximately 70% then proceeded on to fellowships, with cardiovascular surgery, oncology, and plastic surgery attracting the vast majority. One hundred and thirty six of the 244 (56%) accepted academic appointments and the rest entered private practice, the military services, or full-time research in corporations or at the NIH. At present 25 serve as division chiefs or as the head of a large center, eight have been appointed as department chairpersons, one is the dean of a medical school, and one serves as chief executive officer of a large medical education foundation. With few exceptions, former residents who trained in the Duke program consider the research experience to have been beneficial to their careers by creating opportunities for them professionally.

It is my belief all surgical residents should be exposed to a period in their training that introduces them to the processes of creativity and innovation which form the basis of research. My definition of a research experience for surgery residents is broad and includes traditional bench research in a basic science environment and translational and clinical research to move innovation from bench to bedside and validate its value in a scientific manner. Additionally, there are enormous opportunities for surgeons to study healthcare delivery and policy and to develop new approaches to educating ourselves, other medical personnel, and patients.

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A New Look At Surgical Research

The changes occurring in healthcare led us at Duke University to consider a more entrepreneurial approach toward planning and funding surgical research programs. Our goals were to maintain a strong surgical commitment to research to differentiate ourselves from our competition in the clinical and educational arenas, to generate new sources of revenue because we could no longer rely on traditional sources of funding to sustain successful research and education programs, and to prepare our residents to deal with the rapidly changing healthcare delivery system. Some academic surgery departments will decide to focus on clinical care and clinical research and maintain a limited traditional research effort, but others will decide to continue basic, translational, and clinical research programs as part of their overall mission. Whatever the goals, all successful training programs will need to allocate a portion of their human capital and financial resources toward establishing and building educational and research programs in focused areas. In addition, they will need to develop innovative strategies that can be used to finance these programs over the long term. Those who make careful and well-planned investments can maintain high quality research productivity, and when positioned with the correct intellectual capital, can create innovative business opportunities in addition to seeking support through traditional sources. The most important return on research and development investments that will accrue to a department of surgery will be to differentiate themselves as innovators in healthcare and to prepare their residents for the changing healthcare environment. This positioning advantage in the competitive market of healthcare is difficult to quantify but is real and sustainable in the business of healthcare. This approach will require realistic planning, careful prioritization of goals, careful assessment of financial and intellectual resources, and a commitment to implementing the strategy.

The question that must be addressed is how can the knowledge and human resources that reside in orthopaedic surgery best be used to meet the challenges of the future? Regardless of the field of endeavor, only several things are certain: change is essential and inevitable, and change is proceeding at a faster rate than ever before. Whether in industry or healthcare, those that are organized and manage to adapt rapidly to change will prosper in the coming decades. As Michael Hammer has so succinctly stated, “The watchwords of the new decade are innovation, speed, service and quality. Organize around outcomes, not tasks.”5 Success in the future depends on two things- human resources and fiscal resources. How these are managed in a rapidly changing environment is the critical issue and the challenge that must be faced by surgical training programs that wish to remain viable and provide trainees with the opportunity to adapt and be successful in the future. What is state of the art today will not be tomorrow and unless trainees are encouraged and taught to be creative and innovative they risk becoming surgical dinosaurs.

My own field, cardiothoracic surgery, provides an excellent example. As a resident I performed many thoracic surgical procedures for tuberculosis but the development of new drugs has almost eliminated the surgical treatment of that disease. My early career was heavily involved in developing and performing arrhythmia surgery for a wide variety of disorders that could not be managed medically. The introduction of catheter-based ablative techniques and cardiologist-implanted internal cardiac defibrillators has virtually eliminated the role of surgery in the treatment of these disorders. Coronary bypass surgery has decreased dramatically as catheter based interventions and stenting become the preferred method of treatment for the majority of patients with ischemic heart disease. The future in my field will be in innovative methods of restoring or replacing failing myocardium through gene therapy, cellular transplantation, and the perfection of technology to replace the heart. The orthopaedic surgeon will be confronted with similar forms of alternative treatments and we all owe it to our residents to train them to be innovative and adaptive by exposing them to the thought process that forms the basis of all research. Currently, US corporations are investing $300 million annually in orthobiologic research and development, and the author believes that the potential impact on joint replacement, spine surgery and many other orthopedic procedures may exceed that of angioplasty and stenting on cardiac surgery in the next decade.4

To bring about change, there must be stresses that motivate behavioral changes. Although departments of surgery are stressed in a variety of directions, they can and should take pride in their past accomplishments and their special role in society. Surgeons have known success, and while there are ominous signs of discontent and problems on the horizon, the forces to bring about change exist if there is a willingness to plan and execute. Although it is essential that surgical residents receive state-of-the-art clinical training in basic surgical techniques and in the diagnosis and treatment of disease, it is apparent that the introduction of new technologies and procedures has made the practice of clinical surgery a very dynamic field of endeavor. We must assess the surgical environment carefully to prepare our residents for the changes that are inevitable and will greatly influence their professional careers. The system of reimbursement has favored procedurally based specialties, especially surgery, and we are seeing more of these procedures being incorporated in what were once largely considered the cognitive specialties. This trend has rapidly accelerated as the era of minimally invasive therapy has developed and, as the cardiac and general surgeons have discovered to their dismay, no surgical specialty is immune from the changing external environment of healthcare delivery in an open market and highly competitive healthcare system.

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Environmental Assessment

While research dollars continue to grow, society, through its institutions and funding agencies, is saying that we are willing to pay, but we want to direct the areas of research. Hence, we see more rapid growth in research areas such as AIDS, biodefense, cancer, cardiovascular disease, and the chronic and degenerative diseases. Industries now contribute more to university research, but primarily because it benefits their products. Thus, the ability to identify and then respond rapidly to new opportunities becomes critical to the expansion and well-being of the research enterprise. If research and innovation are an important part of the business of a department of surgery, selected individuals must be given responsibility and authority in research, others in undergraduate and graduate education, while still others must direct the clinical effort in meeting patient care expectations and needs. This does not mean that individuals cannot perform in several areas, but it is very difficult, if not impossible, to have the same individuals assuming responsibility for the management of multiple areas with attendant conflicts of interest. A matrix organization is emerging in which functional and divisional lines are combined to take advantage of each. Institutes or centers focused on geriatrics, musculoskeletal disease, molecular medicine, cancer, and cardiovascular disease frequently stimulate research and become a focus for patient care or education. However, they also frequently provide conflicting messages as to where an individual should place his efforts and loyalty, and members of academic faculty usually identify with areas that provide their rewards in terms of space, financing of projects, and compensation.

Regardless of the organizational structure used, it is essential to assign responsibility and authority to manage the activity of each area to assure that defined goals are met. The performance of individuals must be evaluated by predetermined parameters that are used to evaluate productivity in the areas in which they participate and contribute. The percentage of effort in each area must be controlled to assure that the multiple institutional or departmental goals can be met. Faculty are rewarded financially and by the distribution of scarce resources such as OR time, space and equipment on the basis of how well they perform in the areas assigned. This change in structure is altering the role of the department chairmen who must now be leaders and facilitators rather than managers of the departmental efforts in clinical care, research, and education.

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Developing The Financial Plan

For an academic department of surgery to develop an overall plan for research and make sound business decisions, a financial planning process is necessary because investment and financing decisions interact. It must be recognized that the whole may be more or less than the sum of the parts and synergy rather than division must be created through financial planning.

This financial planning process must analyze what makes projects work and what could go wrong with them. It must attempt to trace out the possible impact of today's decisions on tomorrow's opportunities. Financial planning must help establish concrete goals to motivate and provide standards for measuring performance. All investments involve risk, whether they an individual's portfolio or the research portfolio of a department of surgery. The level of financial risk a department should undertake to build its portfolio must be determined by a thoughtful process of planning based on an assessment of the strengths and weaknesses that exist. A careful appraisal of opportunities that are available and threats presented by the internal and external environment is helpful. The department's balance sheet of intellectual, financial, and space resources, and the culture and commitment of all of the involved stake-holders such as the faculty, trainees, and staff must be assessed.

Research planning should never be the exclusive preserve of dedicated planners. Unless clinicians, educators, management, and key members of the research and innovation team are involved in the process, there will be lack of faith in the output. The financial plan put forth by a department must also be closely tied in with the academic medical center business plan for research and development. Financial planning in not an easy topic to consider and it often attracts empty generalities or ponderous detail. Financial planning is a process of analyzing the financing and investment choices available. It is important to project the future consequences of present decisions to avoid surprises and understand the link between present and future decisions. Finally, careful decisions must be made as to which alternatives to undertake and the measurement of subsequent performance against the goals set in the financial plan must be established. Departments of surgery making investments in research must leverage this investment in clinical areas, which will differentiate themselves from competitors. Dabbling in research because it has been considered part of being academic is no longer justifiable simply because it is no longer affordable or a productive use of resources and time.

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Developing The Research Portfolio

As clinical resources have become an ever-diminishing pool of funding for academic endeavors, it is now imperative to develop a more business-minded approach to the funding of research programs. We have found it useful to model research program funding in a manner similar to traditional financial portfolios used in personal and corporate finance. The funding portfolio for a surgical research program may include dollars derived from funding agencies, such as the NIH, or specialty societies. These dollars are competitive and entail the risk of being lost for under-performance at future grant cycles. They are carefully budgeted and require oversight and compliance, which also requires that the appropriate infrastructure be in place. A second source of funding should be corporate. In this regard, surgeons can exploit their intellectual capital by partnering with business to help in the innovative development and testing of products and devices for the surgical arena. Finally, sources of funding through institutional and departmental support and philanthropic donations should be pursued aggressively to allow for the development of startup programs and the maintenance of successful and promising research irrespective of changes in political landscape or corporate interests. If one develops a broad based portfolio of funding, this can withstand shortfalls that may arise from granting cycles, changes in research agendas, or a fallout of corporate support for research. This can allow an investigator to be secure in their funding of employees, which is important for the success of projects, and allow for a broad-based financial position to endure the ever-changing scientific landscape.

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Federal Funding

The NIH has expanded its research funding for many areas of basic and translational science in the past few years. The recently announce NIH Roadmap Initiative has resulted in increasing numbers of requests for applications announced by the NIH to support specific areas of funding.7 To identify these specific programs for which large sums of money are dedicated for research programs, it is essential that a university and/or specific investigator establish mechanisms to identify these novel requests for applications when they arise. It was once possible for the surgeon-scientist to successfully compete for grants that would address scientific problems for unique clinical situations. However, the rate of scientific innovation has increased in the past 10 years with the molecular and genetic revolutions. Thus, for the surgeon to be competitive for peer-reviewed funding from federal sources, it now requires a high level of scientific training or partnerships with successful basic scientists as coinvestigators on these grants. Partnerships with other investigators on the faculty should be sought out so that strategic alliances between a basic science mission and its translation to a clinically relevant problem can be clearly established and articulated in these competitive NIH grants. If these partnerships can be established, with clear evidence of collaboration and a joint scientific goal, the extremely competitive grant review process can become a much more attainable source of funding because of the ability to take basic science innovation and apply it directly to a clinically relevant problem. Examples of this include the area of cardiovascular medicine where innovative therapies in angiogenesis, cell replacement, or thrombosis developed by the molecular biologist can be directly applied using the skills of the cardiovascular surgeon. This appears to be a particularly attractive approach in musculoskeletal disease and opens a myriad of opportunities for orthopaedic surgery. Relationships of this type allow the surgeon-scientist to bridge the gap between basic science and clinical problems and provide the strongest position possible for the success of grants reviewed in study sections, which can all too often criticize the pure clinician for his inability to complete the scientifically relevant work necessary to move a grant forward while maintaining certain clinical responsibilities.

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Corporate and Business Funding

Relationships with business or corporate entities were once scorned among academic investigators as being in violation of the sanctity of the pure nature of the academic mission. However, as medical economics have changed and biotechnology has blossomed, this source of research funding has now become an attractive and potentially important source of support. Academic surgeons and scientists hold a high level of intellectual capital, which is valued by industry. In the past, this intellectual property has often been undervalued and given to industry to support shortsighted goals and to fund some limited research project. However, the rapid pace of innovative technologies now entering the surgical arena demands the need for a high-quality interface with universities during the invention, development, and clinical trial phases of projects. It has been suggested that a majority of innovative devices developed by industry and intended for surgical markets fail to make it to market because of poor insight and input from clinical experts in surgery.3 Identifying key areas of need adds value to the products being developed by industry and can result in important funding opportunities for a department of surgery. Furthermore, these relationships, as they mature, can often lead to important contributions to the research goals of industry. The development of new technologies can be dramatically influenced by the academic partner and result in new products that support the needs of both parties. Once established, these partnerships may also lead to patents and other postdiscovery products that may yield returns to the investigator and/or university in the form of royalties. Partnerships with industry that directly impact the research programs should be encouraged to help develop innovative products and technologies to better patient care. These partnerships can often form a win-win scenario where the investigator and corporation benefit. It is imperative in these relationships that academic researchers maintain the highest level of integrity while realizing the important goals of their industrial partners.

Relationships with companies can be formed in two ways; the first is directly related to innovative product development as discussed above. Secondly, after a long and trusted relationship is established, many corporations can be encouraged to target specific funds strictly for educational and research grants that have no direct ties to product development, but may simply support the academic mission of an investigator or department. An excellent example of this type of relationship is illustrated at Duke University where a corporate partnership with US Surgical Corporation established a large educational grant to fund the development of a laparoscopic surgery center. This laparoscopic surgery center has had long-lasting benefits to the University and its investigators. Furthermore, this relationship has provided direct funding for educational programs and fellowships that otherwise would have to be eliminated or extracted from the shrinking pool of clinical dollars. Such arrangements must be structured carefully to avoid conflicts of interest and to respect the proprietary and financial interests of both parties. The importance of well-defined guidelines supported by an effective office of science and technology within the university structure cannot be overemphasized.

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Philanthropic Support

Philanthropic support for research programs remains an important potential source of funding for research-driven programs with potential clinical impact. Many investigators struggle to obtain competitive funding from granting agencies for innovative ideas that do not appeal to peer-reviewers who have their own priorities. Private donors should be sought who may be willing to direct their funding to meaningful areas of scientific exploration based on their own personal experiences or those of their family. Philanthropic donations can serve as an important core source of support for endowing important scientific chairs, establishing start-up research packages for innovative young investigators, or supporting ongoing projects. Unfortunately, the solicitation of philanthropic donations is often left in the hands of university fund raisers who are unable to articulate the important needs of developing research programs. To maximize the potential for philanthropic donations, lead investigators should be identified and given a high level of visibility to prospective donors so the essential nature of the research mission can be persuasively expressed. An excellent example of this has been illustrated by our prostate cancer and melanoma research programs. These programs hold annual updates in which successfully treated patients for these diseases attend. In this setting, the key investigators present their important findings to the lay public and stress the need for additional research funding. These activities have generated important donations that have allowed these programs to direct research funding to key laboratories in innovative areas. Our orthopaedic surgery group has been highly successful in raising funds through philanthropic efforts and has funded five chairs which support research and education and which have been crucial to their success in these endeavors. Although many surgeons have been uncomfortable with the notion of lobbying patients for money, there should be no shame in asking financially solvent patients and/or charitable organizations for money that can benefit their care and advance new treatments. The time and effort expended by successful investigators who are themselves active clinicians and scientists are appreciated by donors at the individual and foundation level. Surgeons enjoy a unique advantage in this regard but frequently are reluctant to take advantage of it.

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Research As A Business

Research programs have all too often been viewed as a financial drain on clinical departments of surgery. However, as the pool of clinical dollars has continued to shrink, one of the untapped areas of revenue is the department of surgery's ability to do innovative translational research at a premium. These funds can be used to pay for research activities, and extra dollars can be generated to feed back to the department for funding the educational mission. With the rise of biotechnology and innovative surgical devices, the need for these novel therapies to be tested both preclinically and clinically is imperative. If this need is considered a business and educational opportunity, a university that can evaluate the scientific side of a novel technology and has access to patients in whom these technologies may undergo safe clinical trials will have an extremely strong position for leveraging resources to secure competitive industrial contracts. These types of revenue can be separated into three broad categories that are not mutually exclusive: (1) providing expertise and facilities that allow corporate partners to outsource areas of basic research of mutual interest; (2) evaluating translational device development; and (3) providing patients and clinical data management skills for clinical research trials.

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Surgical Science Research Outsourcing Potential

As companies have moved forward in the development of innovative technologies that may be used in the surgical environment, many of them have lacked the expertise to evaluate basic components of these new therapies. Academic basic research laboratories with a high level of expertise in areas such as musculoskeletal disease, materials, and biomechanics can provide research expertise to companies that can neither hire nor afford the expertise in-house. Although few academic scientists have the time or desire to do research for hire, many laboratories have room for corporate partnerships that can generate revenue by providing outsourced research with little drain on their own research program. In the past, when these relationships have been established with universities, the research expertise of an investigator has often not been adequately compensated. However, if one considers the ability to provide meaningful input and high-quality services to corporations, the value of these services is actually very high. If one also considers what it costs these companies to develop the required expertise in-house, it is apparent that a reasonable contract can be developed for research to be performed in concert with a corporate partner. A certain percentage of revenue in the form of direct compensation, royalties, etc can actually be used by the investigator and/or department to pay for innovative programs. It is important to stress the intellectual capital that clinician-scientists represent in these relationships. Obvious problems in new technology development, which may be unnoticed by industrial scientists, may be easily identified and corrected by the high-level of expertise often sequestered in the university laboratory. If these relationships are to be pursued, it is important that an investigator, who previously only thought about the basic needs of their research program, work with more business-minded consultants within the university.

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Translational Device Development

Universities with large animal facilities and underused capacity represent an opportunity for translational device development. Most corporate partners recognize the necessary animal facilities require substantial expenditure to develop and maintain. These resources often exist at major universities and have a strong association with the interventional nature of many surgical research programs. These resources can actually form a strategic area for business development so the margins obtained from a company outsourcing its translational device studies can be used to fund research programs and facilities directly related to the investigator and the department. The value of animal research capabilities as a business opportunity to recruit funding from corporate sources cannot be underestimated. If one samples the industrial leaders in innovative device development, the majority of these companies are in need of skilled personnel and facilities to test and analyze their new devices. This represents an important business opportunity for the entrepreneurial-minded investigator to maintain their own research infrastructure for animal trials and to do complimentary studies for corporations which can yield important financial resources. In this setting, investigators must be careful not to spend valuable time supporting bad ideas, but innovative devices and concepts for development should be tested in appropriate animal models with the perceived benefit of the program having value to the investigator and the corporate sponsor. As highlighted above, the true value of this type of research can not be underestimated and should not be sold short when one considers the inherent cost of the company doing the research themselves. These relationships also allow the academic partner to be linked to the device as it passes from its preclinical evaluation to the clinical trials should a successful intervention be identified. These relationships can be used to offset the infrastructural costs of a vivarium and the technical staff required to maintain resources at a university. A reasonable margin or premium can be determined so these research relationships can actually form a small business enterprise to generate revenue that can feed back into the department and university. Some have expressed concern that this will compromise the mission of an academic department, but one study has suggested that research productivity of investigators is improved by such arrangements.1

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Clinical Research Trials

Clinical research trials in the area of surgery represent a potentially important area of clinical research dollars. If one evaluates for-profit clinical research organizations, less than 10% of their business is related to device or surgical trials. This is primarily driven by a lack of expertise in the clinical research organization industry because clinical research trials in surgery have been hard to maintain and difficult to manage. However, if an appropriate infrastructure can be developed to run surgical and/or device-based trials efficiently, this represents a unique opportunity for an academic clinical research organization- type business to develop. An excellent example of the success of an academic clinical research organization has been illustrated by the Duke Clinical Research Institute (DCRI), which has found a unique niche in running large-scale high-quality clinical trials for corporations. To date, the majority of these trials have focused on drug therapies, but success in cardiology device development indicate the ability to extend into device development and surgical clinical trials. Departments of surgery with high clinical volumes represent an ideal business opportunity to develop an academic clinical research organization-based infrastructure that can position themselves for competitive clinical trials in the evaluation of novel surgical technologies.

The majority of surgical trials to date have been fraught with problems related to inconsistent site management under the direction of misguided and non-conforming surgeon investigators. This has led many studies to fail, not because the device or technology does not work or have a clinical benefit, but rather because clinical protocols and Federal Drug Administration-quality data are simply overlooked or bypassed. The cost of developing a small clinical research infrastructure at each unique surgical center is also logistically difficult and often cost prohibitive. This provides a unique business opportunity for a surgically based academic clinical research organization to establish linked sites with aligned partners to run efficient clinical trials. This can provide cost savings for industry and provide a high level of revenue to fund clinical trial infrastructure and the associated support personnel. This also allows the academic researcher direct access to early clinical information in the development and success of a new technique and provides a unique academic opportunity for publication in the advancement of new knowledge.

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It is reasonable to envision a future where highly qualified members of an academic orthopaedic department, with an aptitude for basic, translational, and clinical research, generate substantial revenue that can support the infrastructure of their own research operation. Moreover, such a successful research enterprise could likely generate excess revenue to fund the greater academic mission, providing educational opportunities for residents to be better prepared to deal with innovation and change driven by science and research.

Such an approach requires an innovative mind-set that no longer looks at research as a financial liability, but rather a business opportunity that can positively impact surgical training programs. This perspective deviates somewhat from the traditional arguments in favor of mandating a research experience within the context of clinical surgical training programs. Whereas others have suggested that the value of surgical research training lies in its role as a farm system for developing funded surgeon scientists, purists have rebutted this notion by offering that such a research exposure is too short and superficial to produce a surgeon scientist who can successfully compete for extra- mural funding. Likewise, the notion that a research experience teaches residents how to think critically and analyze the literature might be an impractically expensive approach, wasteful of scarce resources, to achieve a critically-thinking clinician. Rather, at a time when the value of clinical surgical expertise related to patient care has diminished in the eyes of third-party payors and the federal government, the university research enterprise may represent the financial future of surgical departments, which can exploit the value of their own faculty and housestaff to invent, develop, and test novel therapies and improve patient care. This may be the most pragmatic and sustainable rationale for academic surgical departments to pursue research endeavors, while concurrently providing a secondary benefit to residents in training in the form of exposure to the processes of research that will prepare them to deal with the ever-changing landscape of clinical healthcare as they pursue their own professional careers.

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© 2006 Lippincott Williams & Wilkins, Inc.