4 SrectaL ARTICLE “To John I. Gallin, MD, and Harold Varmus, MD Revitalization of the Warren G. Magnuson Clinical Center at the National Institutes of Health For nearly 45 years the Warren G. Magnuson Clinical Center has been the site of the intramural clinical re- search of the National Institutes of Health. Ir has served as the largest clinical research facility for the nation and the site for training many of the clinical investigators in the nation’s academic medical centers. Research at the Clini- cal Cenrer has focused on study of orphan diseases and phase 1 and 2 clinical trials, and this research emphasis has made it a special national resource. Over the last decade there has been a dramatic decline in che number of patients seen at the Clinical Center, as well as a perceived decrease in the quality of research performed at the center. The decreased activity is related in part to fiscal con- straints and the impact of the changing health care deliv- Fat oe Utes ery system. The trends at the Clinical Center are particu- larly distributing because they parallel what is happening at academic health centers across the country. Because its success is viewed as vital to national clinical research, a tnajor effort has been undertaken to revitalize the center This paper reports on the plans and activities undertaken to reorganize the center's management, revitalize its infra- structure for conducting clinical research, establish vical clinical research waining, and promote parmerships with extramural investigators who will benefic from access co the center. The hope is chat che model established at the NIH Clinical Center will assist in the revitalization of clinical research across che nation. Acad. Med. 1998;73:460-466. he Warren G. Magnuson Clinical Center (Clinical Center) at the National Institutes of Health (NIH) helped spawn the nation’s clinical research enterprise, including the NfH-funded General Clinical Research Centers (GCRCs) in academic medical centers, through its research accomplishments and the train- ing of clinical investigators. For years the Clinical Center was a major force in clinical research, but the growing strength of academic medical centers has challenged its sta- tus. Furthermore, its physical infrastructure is deteriorating, and a perception exists that the Clinical Center has lost its vigor. In addition, the nation’s entire clinical research enter- Dr. Gallin is director, Warren G. Magnuson Clinical Center, National In- stitutes of Health, and Dr. Varmus is director, National Institutes of Health, Bethesda, Maryland. Correspondence should be addressed to Dr. Gallin, Waren G. Magnuson Clinical Center, 9000 Rockville Pike, Building 10, Room 2C146, Bethesda, MD 20892. 460 ACADEMIC MEDICINE, prise, including the Clinical Center, is now under stress, pri- marily because of changes in the health care delivery system.!? In chis article, we oucline recent efforts to revital- ize che NIH Clinical Center in order to secure the future of clinical research across the United States. SCOPE OF CLINICAL CENTER ACTIVITY As the research hospital of the NIH, the Clinical Center supports the intramural clinical research programs sponsored by 15 NIH institutes. The interdependence of the hospital and the institutes provides the framework for laboratory and clinical collaboration characteristic of the Clinical Center. The Clinical Center services nearly 50% of the inpatient days and 25% of the outpatient visits at all NIH—supported GCRCs. It was designed with laboratories adjacent to pa- tient care units so that clinical investigators could move rapidly between the bench and bedside. When the Clinical Center opened in 1953, it had 550 beds and was referred to as a national center for chronic disease research’; today, it is Vot. 73, No.5/May 1998 WARREN G. MAGNUSON CLINICAL CENTER, CONTINUED a 325-bed hospital with a 13-story ambulatory care research facility (added in 1980). Every patient admitted to the Clinical Center is enrolled in a clinical protocol. The center supports approximately 900 active clinical protocols that focus on disease pathogen- esis in cohorts of patients with rare (“orphan”) diseases and include a large number of phase 1 and 2 clinical trials. This emphasis has positioned the Clinical Center to represent an important section of the nation’s clinical research portfolio as well as an important referral center for evaluation and management of orphan diseases. Numerous significant med- ical advances have occurred at the Clinical Center, includ- ing the first implantation of artificial heart valves, use of lithium for bipolar disorders, use of AZT for AIDS, and the use of multiagent chemotherapy for cancer. Despite these medical advances, the patient census has declined in recent years. The number of inpatient days fell from 98,276 in 1990 to 58,404 in 1996, while inpatient ad- missions fell from 9,314 to 6,300 and outpatient visits de- clined from 76,268 to 68,346. (Throughout this article “year” refers to federal fiscal year: October 1—September 30.) This reduction is similar to patterns observed in many US. academic health centers and is a result of numerous fac- tors, including fiscal constraints, the impact of managed care on patient referrals, and a slight decline in length of stay (from ten days in 1990 to nine days in 1996). CLINICAL CENTER REVIEW MANDATED The decline in patient census and the deteriorating physical facility that has outlived its projected life span have raised concern about the future of the Clinical Center.4~® In early 1995, the Department of Health and Human Services (DHHS) Secretary, Donna Shalala, mandated a review of the Clinical Center to identify bureaucratic obstacles to effi- ciency.‘~® Because strong management of operations was deemed crucial to support clinical research, Secretary Sha- lala specified that the review evaluate che operations of the Clinical Center and recommend changes that would assure sustained leadership. In addition, the review team was to consider whether privatization of the Clinical Center (con- tracting all or some services to non-government firms) would save money and improve efficiency. The review was conducted by a team of extramural and intramural reviewers that submitted a report to Secretary Shalala in January 1996.’ As part of che review, 30 acade- mic medical centers were visited in order to set bench- marks for best practices. The report offered four recom- mendations for broad organizational changes related to governance, funding, planning, and flexibility. Secretary Shalala accepred these recommendations, and they are be- ing implemented. ACADEMIC MEDICINE, Governance The reviewers recognized that the governance structure of the Clinical Center is ambiguous, overly complex, and not designed for streamlined decision making. This situation de- tives from the Clinical Center's efforts to provide service to the 15 institutes that use the facility. Each institute has a di- rector, a scientific director, and a clinical director, who over- see the scientific and clinical activities of their institute's in- tramural programs. The institute directors have broad oversight of all extramural and intramural programs, the sci- entific directors are responsible for management of all the intramural programs, and the clinical directors oversee the intramural clinical programs. Governance of the Clinical Center has traditionally depended upon achieving consensus among these groups, a process that the review team deemed cumbersome and inefficient. For example, institute “owner- ship” of the Clinical Center's resources complicates the es- tablishment of new operating efficiencies, since decisions made for hospital-wide improvement occasionally conflict with institute-specific desires. The review team recommended that a “clear, logical gov- ernance structure should be developed ... through a Board of Governors with extramural and intramural mem- bers.” A Board of Governors has been chartered? and con- sists of 15 members appointed by the DHHS Secretary. The board will advise the NIH director and the Clinical Center director. In chis way, for the first time, che extramural com- munity will participate in the governance of the Clinical Center. Extramural representation on the board adds new expertise in hospital management and assures that intra- mural managers are sensitive to extramural concerns. The chair of the Board of Governors is required to be from out- side the NIH, and non-government members— experts in health care governance, management, and clinical re- search——comprise eight of the 15 members. Intramural members are a cross-section representation of the institutes’ clinical and scientific staffs. In view of the importance of nursing to clinical research, at least one registered nurse is included on the board. The Board of Governors is charged to approve the Clinical Center's strategic plan, review the annual budget, advise the NIH director about hiring, perfor- mance, and compensation of the Clinical Center director, and annually review the planning and resource use of each institute’s clinical program. The Board of Governors does not oversee the scientific projects of the institutes; this func- tion continues to be carried out by institute directors and scientific directors with advice from extramural reviewers participating on each institute’s Board of Scientific Coun- selors. To assure continued input from intramural users of the center, a Clinical Center Advisory Council, with repre- sentatives from the institutes, has been established. VoL. 73, No.5/May 1998 461 WARREN G. MAGNUSON CLINICAL CENTER, CONTINUED Funding In recent years, as the NIH budget tightened and health care costs grew, some institutes reduced their levels of clinical re- search in favor of less costly laboratory research. Such efforts to be fiscally responsible contributed to an unstable patient census. Clinical Center clinicians are concerned that this level of use may be approaching the threshold necessary to sustain the center. To stabilize clinical activity, the review team recommended that The Clinical Center should have a clearly defined budget of its own. . . . {and the] budget should be no less inherently predictable than the budget of NIH as a whole. To improve continuity and stability, [the budget should] allow savings in operating expenses to be reinvested within the Clinical Cen- ter from year to year. A new budget process is being developed that will provide fucure fiscal stability for the Clinical Center while assuring that all institutes have fair access to Clinical Center facili- ties. To provide new flexibility in planning, the Clinical Center has been given permission to reinvest savings for use in the following year. Planning The third recommendation by the secretary's review team was that “a strategic plan be developed for the Clinical Cen- ter with clear and measurable objectives.” Although a draft plan was prepared in 1990, the Clinical Center had never implemented a formal strategic plan. The review team felt that such a plan could serve as a blueprint for creating a stronger infrastructure for supporting clinical research. A new plan has been drafted that includes long-range goals of excellence in clinical research and training, quality patient cate, cost—effectiveness, and efficiencies. One of the first actions of the Board of Governors was to approve this new strategic plan (available on the World Wide Web at ). Flexibility The review group identified numerous bureaucratic obstacles to efficiency and recommended that “to achieve greater flex- ibility and operating efficiency, the Clinical Center should be designated . . . a Reinvention Laboratory.” Vice Presi- dent Albert Gore defined reinvention laboratories as places where we can immediately unshackle our workers to re-engineer their work processes, and fully accomplish their missions. These will be offices where we can fully delegate authority and responsibility, replace regulations with incen- tives, and measure our success by customer satisfaction. '° 462 ACADEMIC MEDICINE, Asa “reinvention laboratory,” the Clinical Center would be- come a federal demonstration site in which reduced regulation, enhanced local autonomy, and improved federal personnel and procurement practices are tested. Such a designation would free the center to try novel ways to procure goods and services, manage personnel, and use operating savings creatively with- out compromising the quality of clinical research. Although the Clinical Center has not been formally designated a rein- vention laboratory, new authorities granted by Secretary Shalala to the NIH and the Clinical Center and pending leg- islative initiatives will achieve many of the objectives of rein- vention status even without the formal designation. The review team concluded that implementation of these recommendations would be more beneficial than privatiza- tion because removing bureaucratic obstacles would result in major savings that would have been largely lost as overhead for a private contractor. In addition, the review concluded that privatization would impinge on the delicate relation- ship between the institutes and the Clinical Center and thereby endanger the clinical research mission of the NIH. RECOVERY OF FUNDS FROM THIRD-PARTY PAYERS Ever since the Clinical Center opened, incidental care has been free to the patients participating in its research proto- cols. For more than 20 years the NIH opposed collection of third-party payments for care associated with research at the center. Reluctance to pursue recovery of funds from third- party payers was based on the difficulty of distinguishing stan- dard care from clinical research, the impact that third-party collection would be likely to have on patient recruitment to protocols, the expense attached to traditional billing, and the potential disruption to clinical research associated with the bureaucracy needed for third-party collection. President Biil Clinton’s NIH budget request for 1997 called for the Clinical Center to collect $18 million from third-party payers, and the Congress granted the NIH per- mission to collect third-party payments at the Clinical Cen- ter. In response, the center began discussions with third- party payers about how funds might be recovered, considered ways to identify and track costs for care provided, and col- lected insurance information from patients. Our dialogue with business representatives revealed their concern that se- lective acceptance of patients to NIH protocols would create a perception of unfair access of certain patients to the Clini- cal Center. Third-party payers were concerned that payment for care associated with research at the Clinical Center would establish a precedent for third-party payment for all care associated with clinical research nationally. A six- month survey of patients revealed that the Clinical Center could not collece insurance from about 60% of them because they had no insurance or had federal insurance. (By policy, federal health insurance can not be collected by the Clinical Vout. 73, No.5/May 1998 WARREN G. MAGNUSON CLINICAL CENTER, CONTINUED Center.) The survey also revealed that more than 1,000 third-party payers represented the insured patients, creating bureaucratic difficulties for collection. The Board of Gover- nors concluded that the risk to the mission of the Clinical Center did not justify che high cost of developing a collec- tion process, and the board recommended against recovery of third-party payment. A final decision on third-party col- lection will be made after review by the administration. ENHANCING INFRASTRUCTURE TO SUPPORT CLINICAL INVESTIGATORS AT THE NIH Many activities and facilities are essential to a strong clinical research environment. These include training programs, ad- ministrative support, and scientific infrastructure. All of these areas, which are of interest to all medical centers con- ducting clinical research, are targeted for improvement in the Clinical Center's strategic plan. Training Programs Despite general acceptance of Flexner's 1925 dictum that training, research, and care are intertwined,'! formal train- ing in clinical research has not been emphasized at most aca- demic medical centers or the NJH.!? The Clinical Center, with its large number of studies and physicians from many specialty areas, is in a strong position to help correct this lack of training in clinical investigation. Last year, the Clini- cal Center introduced a new curriculum in clinical research for physicians, physician assistants, nurses, and PhD scien- tists, open to both intramural and extramural investigators. The centerpiece of the curriculum is the Clinical Center's introductory core course, with additional courses on biosta- tistics and epidemiology offered by the NIH Foundation for the Advancement of Education in the Sciences. The core course on clinical research includes lectures and practical experiences with protocol reviews through mock institu- tional review boards. The course has four modules that ad- dress epidemiologic methods, ethical and regulatory issues, oversight of patient-oriented research, and strategies for or- ganizing and funding a clinical research study {List 1). The syllabus for the course has been placed on the World Wide Web at , and a textbook is under development. In addition, the Clinical Center is pursuing collaboration with other medical schools thac offer advanced master’s and PhD degrees (one has al- ready been initiated with Johns Hopkins University and an- other is under development with Duke University). In addi- tion, the Clinical Center will be experimenting with collaborative teaching at remote medical centers using state- of-the-art telecommunications. The need to train medical students to conduct clinical re- search has been highlighted recently by the NIH Director's List 1 Introductory Couren an Clinteal famuarch, Watienet Institutes of Health Module Epidemiologic methods Content Study design and development; ctinicat trials design; measurement; analyz- Ing and presenting data; biostatistics in clinical trials; meta-analysis, sur- vival analysis, and quality-of-life analysis Ethical principles; legal Issues; reguta- tion of human subjects research; the institutional review board (IRB); gen- der and race diversity in study popu- lations; and scientific conduct Data management in clinical trials; monitoring clinical trials; quality assurance in the hospital setting: relations with the Food and Drug Administration; alternative and com- plementary therapies; data- and safety-monitoring boards; dissemi- nation of information; and technol- ogy transfer Infrastructure for clinicat research; analysis of resources required for clinical research; how to succeed in the NIH peer-review process for grants; and writing a clinical re- search protocal Ethical and regulatory issues Oversight of patient- oriented research Preparing and funding actinical research study Clinical Research Panel under the leadership of Dr. David Nathan from the Dana-Farber Cancer Institute. At the sug- gestion of this panel, a program to bring medical students to the NIH for intensive training in clinical research at the Clinical Center has begun with nine students, enrolled from nearly 80 applicants in 1997. The plan is for this program to grow to 30 students per year. If successful, the program will be replicated at medical schools throughout the country. Administrative Support Specific areas of administrative support are targeted for im- provement in the strategic plan—patient recruitment, pro- tocol services, and information systems. Patient recruitment. The growing managed care industry has made attracting patients a competitive business for many health care providers. At the same time the source of patient referrals to research protocols has shifted from primary care physicians co managed care organizations. This has pre- sented a unique challenge to the Clinical Center. To main- tain a steady. stream of participants to protocols, a patient re- ACADEMIC MEDICINE, Vot. 73, No.5/May 1998 463 WARREN G. MAGNUSON CLINICAL CENTER, CONTINUED cruitment service center has been established co help iden- tify patients for specific protocols and to coordinate the in- teraction of NIH investigators with referring physicians and with managed care organizations. Educating the public about clinical research is also impor- tant. The Clinical Center is developing materials for the public about its role, the importance of clinical research, and what it means to be a patient volunteer in clinical research. Patients and referring physicians may have difficulty identi- fying active protocols for their specific clinical problems. To address this issue, NIH intramural clinical protocols have been placed on the World Wide Web at . The protocol! database can be searched easily by symptoms or diagnosis and is designed for both lay and professional commu- nities. An abstract of each protocol is provided, along with a guide to e-mail correspondence with the Clinical Center. The Clinical Center is also trying to combine all NIH—sponsored intramural and extramural protocols into a common database available through the World Wide Web. The national proto- col database will guide patients and referring physicians to all active protocols and will assist all NIH—sponsored intramural and extramural investigators with patient recruitment. Protocol services. Local coordination of all clinical proto- col activities has become an increasingly important service to provide to clinical investigators. Over the past few years, ever-increasing numbers of committees have been estab- lished to approve protocols, adding time and complexity to the protocol-approval process. Therefore, a protocol coordi- nation service center has been established at the Clinical Center co assist principal investigators with all aspects of protocol development, review, implementation, and moni- toring. A new feature is the use of protocol maps for individ- ual protocols. These protocol maps provide details of all tests and procedures for each admission, enable accurate projec- tions and monitoring of protocol costs, address the expecta- tions of patients and referring physicians, and establish a database for coordination of all aspects of protocol imple- mentation. Information systems. Clinical research requires the best information systems for coordination of clinical research and fiscal data. Over che last two years, the commitment of re- sources to information systems at the Clinical Center has in- creased from about 2% to over 4% of the budget. Recent ad- ditions include an improved medical information system containing all clinical information and a new, very popular “standard clinical desktop” available at all computer stations in patient care areas. This standard clinical desktop includes electronic searching of leading textbooks of medicine and pharmacology, expanded access to the World Wide Web, lit- erature searches using the National Library of Medicine’s Pub Med, a graphics package to design, organize, and present data for papers or presentations, a powerful word processor, a 464 ACADEMIC MEDICINE, spreadsheet, summaries of all NIH intramural protocols, and protocol consent forms for all intramural protocols. In addi- tion, an executive information package to help institute ex- ecutives manage Clinical Center resources should be com- pleted this year. This new package will provide managers with current information about personnel use and budget status and will help them monitor their use of Clinical Cen- ter resources and project their fucure requirements. Scientific Infrastructure Service centers. The Clinical Center's strategic plan calls for strengthening several scientific services to support clini- cal investigation. Clinical epidemiology and biostatistics and stem-cell harvesting will receive special emphasis. Although some of the largest institutes at NIH have strong clinical epidemiology and biostatistics facilities, many of the smaller ones have little or no access co these services. A new clinical epidemiology and_ biostatistics service center will assist investigators in the smaller institutes in protoco! design and in establishing data and safety monitoring boards. A new stem-cell facility within the Clinical Center's Department of Transfusion Medicine has been opened. It will coordinate the har- vesting and processing of stem cells to be used as targets for gene therapy and for bone marrow trans- plancs. Protocol review. There are over 900 active protocols at the Clinical Center, with approximately a 25% curnover each year. To assure top-quality clinical research within the intraroural programs, protocols are reviewed prospectively by sponsoring institutes for cost and scientific potential, and annually by the Clinical Center for patient accrual (includ- ing meeting demographic objectives) and cost. In addition, all intramural clinical research programs are reviewed retro- spectively every four years by a team of extramural reviewers called Boards of Scientific Counselors. The boards review all intramural clinical investigators for the quality and cost of their clinical research. In addition, the network of institute- based incramural institutional review boards (IRBs) is under evaluation by the NIH Deputy Director for Intramural Re- search to be certain that the IRBs function efficiently and are of uniformly high quality. EXTRAMURAL OUTREACH To help alleviate the national crisis of increasingly scarce re- sources for clinical research, the Clinical Center has created a number of outreach activities to extend its services to ex- tramural investigators. The new stem-cell facility (described above) is exploring ways to assist extramural colleagues with their cellular and gene-transfer protocols. The Clinical Cen- VoL. 73, No.5/May 1998 WARREN G. MAGNUSON CLINICAL CENTER, CONTINUED ter will encourage extramural investigators to collaborate with intramural investigators in projects that use its high- technology resources, such as the positron emission tomogra- phy (PET) scanner, and to study the unique cohorts of pa- tients with orphan diseases. New sabbatical programs for extramural investigators to come to the Clinical Center have been developed to allow extramural investigators to spend time with a Clinical Center investigator and then continue projects long term with regular visits to che center. An additional objective is stronger relationships with the NIH-funded GCRCs. One academic medical center has suggested that the Clinical Center assist in coordinating multicenter clinical trials carried out at GCRCs and at the center. Telecommunications and telemedicine technology are being puc in place at the Clinical Center to support such interactive projects. To improve intellectual exchange among medical centers, selected NIH Clinical Center Grand Rounds and a new Clinical Center Roundtable are now televised live to more than 1,000 medical centers nationwide through GE Tip-TV Healthcare Network and CenterNet. Remote participants may phone in during the question-and-answer sessions. In addition, the Clinical Center has begun using telemedicine for patient recruitment, patient follow-up, and new collabo- rations with primary-care investigators in remote locations. Telemedicine technology is expected to enable primary-care physicians and physician assistants to participate in clinical research protocols. Two telemedicine suites are being devel- oped at the center. The Clinical Center is not a full-purpose hospital; there is no emergency room, and certain specialties, such as orthope- dic surgery, are not available. This limits the scope of clini- cal research that can be pursued and is an obstacle for ideal training of young clinical investigators. To broaden the available programs, the Clinical Center has pursued venues to broaden the scope of clinical research. For example, a partnership was recently formed between the NIH Clinical Center, Suburban Hospital in Bethesda, Maryland, and The Johns Hopkins University in Baltimore. This alliance will broaden the clinical training of young investigators and sup- port new studies of emergency conditions, such as trauma, acute stroke, and myocardial infarction. Partnerships with other hospitals in the Washington, D.C., area and through- out the country are under development and will be made possible with telemedicine technology. New NIH CLINICAL RESEARCH CENTER The 43-year-old Clinical Center is now functionally obso- lete, inefficient to operate, and expensive to maintain, a conclusion supported by an in-house study done in 1988, a separate review by the U.S. Army Corps of Engineers in ACADEMIC MEDICINE, 1991, a review of the NIH intramural programs mandated by Congress in 1994, and the 1996 review of the Clinical Cen- ter by Secretary Shalala’s committee.’ Each of these reviews concluded that failure to act soon would result in hundreds of millions of dollars in repairs, operating-cost increases, un- acceptable risks of systems failure, disruption of services and research programs, and, most important, threats to the safety of patients and employees. In 1997 Congress approved construction of a new clinical research center, in recognition that it was a necessary part of NIH’s responsibilicy to improve the quality of clinical research. Congress named the new facility che Mark O. Hatfield Clinical Research Center. The initial plans describe a building with 850,000 square feet, including 250,000 square feet of contiguous laboratory space.’ A design com- petition selected the Zimmer, Gunsul and Frasca Partner- ship, located in Portland, Oregon, to serve as architects. The firm was selected on the basis of its experience, assembled team of consultants, and proposed highly flexible design, which was deemed least obtrusive to the existing campus and surrounding community. The new clinical research center will be smaller than the existing one, with 250 inpatient beds, compared with 325 open beds in the existing facility. In addition, the new clini- cal research center will have expanded day-hospital re- sources for patients who require longer observation times than are possible in traditional outpatient clinics. The day- hospital resources will increase from the current 60-“chair” capacity co 100-hospital “chairs.” Routine clinic space, the clinical pathology and radiology departments, and the surgery suites will remain in the current facilicy but will be connected to the new building. The long-range plan is to convert the present inpatient units and old laboratories to modern laboratories. To make a smaller, more efficient clinical research center possible, a major change must occur in the assignment of clinical resources to user institutes. Agreement about this new process highlights the spirit of collaboration and cooper- ation that the research institutes and the Clinical Center have formed. Currently, specific wards are assigned to partici- pating insticutes, but the new center will have generic space shared by the institutes. Shared space and better manage- ment will save money. Major advances in information trans- fer are anticipated. Telemedicine rooms will connect elec- tronically to extramural sites, and television monitors throughout patient-care areas will facilitate the transfer of radiologic, anatomic, and pathologic images to patient-care providers. The new clinical research center, which is ex- pected to be completed in 2002, will provide an inviting en- vironment for extramural investigators and, most important, a healing environment in which to provide the best care to patients participating in clinical studies. Vor. 73, No.5/May 1998 465 WaRREN G. MAGNUSON CLINICAL CENTER, CONTINUED CONCLUSION The foregoing efforts to revitalize the NIH Clinical Center will provide a strong foundation to help invigorate the na- tion’s clinical research enterprise. Among other things, the renewed Clinical Center will encourage new collaborations with extramural investigators through study of the rich vari- ety of patient populations, unique technology, and special services available act the NIH. 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