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Eulogy for the Clinical Research Center

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Eulogy for the Clinical Research Center Eulogy for the clinical research center David G. Nathan, David M. Nathan J Clin Invest. 2016;126(7):2388-2391. https://doi.org/10.1172/JCI88381. Op-Ed The extramural General Clinical Research Center (GCRC) program has been funded for more than 50 years, first by the National Center for Research Resources, NIH, and more recently as part of the Clinical Translational Science Award (CTSA) program through the newly formed National Center for Advancing Translation Sciences (NCATS). The GCRCs represent the federally funded laboratories that employ a highly trained cadre of research nurses, dietitians, and other support staff and in which generations of clinical investigators trained and performed groundbreaking human studies that advanced medical science and improved clinical care. Without the opportunity for adequate discussion, NCATS has now stopped funding these Research Centers. In this “eulogy,” we review the origins and history of the GCRCs, their contributions to the advancement of medicine, and the recent events that have essentially defunded them. We mourn their loss. Find the latest version: https://jci.me/88381/pdf OP-ED The Journal of Clinical Investigation Eulogy for the clinical research center David G. Nathan1 and David M. Nathan2 1Dana Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA. 2Diabetes Center and Clinical Research Center, Massachusetts General Hospital (MGH), Harvard Medical School, Boston, Massachusetts, USA. icans with a desire to learn the biomedical research technology of the early twentieth The extramural General Clinical Research Center (GCRC) program has been century were forced to travel to England, funded for more than 50 years, first by the National Center for Research France, Austria, or Germany. Resources, NIH, and more recently as part of the Clinical Translational The first American hospital entirely Science Award (CTSA) program through the newly formed National Center devoted to clinical research was created for Advancing Translation Sciences (NCATS). The GCRCs represent the at Rockefeller University in 1910, where federally funded laboratories that employ a highly trained cadre of research a score or so of beds were surrounded by nurses, dietitians, and other support staff and in which generations of basic research laboratories. The hope was clinical investigators trained and performed groundbreaking human studies that basic science would create new tech- that advanced medical science and improved clinical care. Without the nologies that would be explored at the opportunity for adequate discussion, NCATS has now stopped funding these bedside to understand and improve the Research Centers. In this “eulogy,” we review the origins and history of the prognosis of patients. Harvard Medical GCRCs, their contributions to the advancement of medicine, and the recent School copied the Rockefeller model when events that have essentially defunded them. We mourn their loss. the ten–research bed “Ward 4” opened at MGH in 1925 (6). It was in those beds that Fuller Albright, the father of endo- crinology in the US, studied hyperpara- Introduction Working Group report (5), although neither thyroidism and its effective treatment. In The Clinical Research Center (CRC) pro- report included any specific recommen- the same decade, Francis Weld Peabody, a gram, supported by NIH extramural fund- dations regarding the CRC program, and former MGH house officer, was recruited ing, is now dead (1). The CRCs included the several members of the IOM Committee by Harvard Medical School to lead a larger only federally supported beds (~600 nation- whom we contacted have denied any such clinical research enterprise, the Thorndike wide) and outpatient human research “lab- intent. The defunding of the CRCs, the Memorial Laboratory and the Thorndike oratories” in academic medical centers ded- home of federally funded clinical research Research Ward at the then Boston City icated to support all clinical investigators. for more than 50 years, including the space Hospital (7). He in turn recruited two other Until recently, the CRCs provided many that they occupy and their highly trained graduates of the MGH program, George services free of charge to federally funded research staff, has occurred with virtually Richards Minot and William Bosworth investigators. Industry-initiated studies no discussion in the scientific commu- Castle, to join him. Minot and others were charged for services provided. nity. As experienced CRC users and as the received a Nobel Prize for their contribu- Originally funded from the 1960s director of a GCRC/CRC for more than 25 tions to our understanding of the role of as the General Clinical Research Center years (D.M. Nathan), we mourn their loss vitamin B12 deficiency in pernicious ane- (GCRC) program through the National and here present our eulogy. mia. Castle is correctly considered one of Center for Research Resources (NCRR), the founders of modern hematology. support for CRCs became part of the Clin- The role of clinical center ical and Translational Science Awards investigation in Establishment of the (CTSA) program in 2006, which was sub- American medicine intramural and extramural sequently incorporated into the newly The history of research-oriented “beds” clinical research center established National Center for Advancing is actually the history of modern aca- programs by the NIH Translation Sciences (NCATS) in 2011 (2, demic medicine. Less than a century ago, Biomedical research success in the United 3). Funding support for the CRCs began American medical schools were largely States is the product of the interaction of to be restricted by NCATS within several trade schools. Laboratory-based academic three forces: the proper amalgam of basic years of its creation. The eventual total inquiry barely existed within them. Johns and clinical biological research effort, defunding of the CRCs was carried out Hopkins, the University of Michigan, together with advanced clinical care, purportedly on the basis of Institute of and the University of Pennsylvania had within the academic biomedical commu- Medicine (IOM) recommendations (4) and nascent academic programs that were nity; the continued effort of profit-moti- a subsequent NCATS Advisory Council carried out largely by pathologists. Amer- vated pharmaceutical and biotechnical companies; and the overall support of the enterprise by the NIH and other mem- Reference information: J Clin Invest. 2016;126(7):2388–2391. doi:10.1172/JCI88381. bers of the grant-making and donor com- 2388 jci.org Volume 126 Number 7 July 2016 The Journal of Clinical Investigation OP-ED munity. The directors of the NIH have Contributions of the GCRC and the uniform conduct of multicentered had a profound influence on biomedi- program NIH-sponsored studies have depended on cal research in the United States. Lewis The first extramural GCRC grants from the GCRC facilities and their expert staff. Thompson, the fifth director, secured the the NIH were awarded in 1963 to sev- Moreover, young investigators with insuf- present NIH campus and built its first six eral leading teaching hospitals around ficient funds to build facilities and recruit buildings including the National Cancer the country. The grants provided stable and train their own staff to conduct their Institute. Rolla Dyer, the sixth director, support for the necessary research space, early work found a “rent-free” home in planned the Clinical Center, the NIH’s beds, and equipment to carry out exper- the GCRCs, as most of the infrastructure central clinical research facility, and estab- imental measurements and therapeu- for clinical research was supported by the lished the National Heart Institute and tics in volunteer patients. The GCRCs institutional GCRC grants. the National Institute of Mental Health. included a highly trained, specialized staff James Shannon, the eighth director (1955– of research nurses, coordinators, statisti- The death of the CRC 1968), played a transformative role as he cians, research subject advocates, bioin- Increasing concern regarding the decline in presided over the massive growth and formaticians, and bionutritionists, who applications for NIH grants from aspiring influence of both the intra-and extramural reliably carried out complex research pro- research-oriented physicians during Wyn- programs of the NIH, including the initi- tocols from myriad investigators. gaarden’s and Varmus’ tenures led to the ation of the GCRC program. The GCRCs For the next 40 years, the contribu- 1995 formation of a Directors Committee aimed to provide medical scientists “who tions of the GCRCs to medical research on Clinical Research (17). The 1995 com- receive their primary research funding were outstanding. Although endocrinol- mittee (chaired by D.G. Nathan) advanced from the other components of the NIH” ogy, nephrology, and metabolism were a broad definition of clinical research that with “the resources which are necessary the major beneficiaries early on, as those included: (a) laboratory-based studies of for the conduct of clinical research” (3). fields particularly require careful measure- patients and their biosamples and tissues; Shannon’s regime produced the eleventh ments of body fluids that can only be well (b) studies in humans of mechanisms of (Donald Fredrickson), twelfth (James performed in a research environment, the disease, therapeutic interventions, and the Wyngaarden), and fourteenth (Harold GCRCs, and now CRCs, have served every development of new technologies;
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