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The Biomedical Research Environment in the ~ 980s Throughout the 1980s and 1990s many investigators continued sounding the alarm about the state of translational research. Like Wyngaarden, Gill (1984), Arias (1989), Hartwell (1992), Bunn and Casey (1995), Goldstein and Brown (1997), Shine (1998), and Nathan (1998), among others, expressed marked concern that a shortage of clini- cal researchers was endangering our nation's leading role in today's bio- medical revolution. A shortage of clinical researchers was clearly contrib- uting to a widening gap between those discoveries made in He basic science laboratories and the application of discoveries to conquer human diseases. Physician-scientists are key to bridging the gap since they relate to both human patients and laboratory research (Rosenberg and Ley, 2003~. In 1988 the National Institutes of Health (NIH) commissioned the Institute of Medicine (IOM) to assess the availability of resources for per- forming clinical research. That study committee found that the number of highly talented young medical school graduates pursuing careers as clinical investigators was declining. As many as 20 percent of clinical traineeships and fellowships were filled by individuals with the Ph.D. degree rather than the M.D. degree (Institute of Medicine, 1988~. Follow- ing the release of the committee's report, Resources for Clinical Investiga- tion (Institute of Medicine, 1988), the IOM convened a planning meeting to develop a strategy for exploring problems associated with clinical re- search training. 22
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THE BIOMEDICAL RESEARCH ENVIRONMENT IN THE 1980s 23 In the second half of the twentieth century the production of Ph.D.s in the life sciences increased substantially. In 1960 there were 1,160 doctor- ates awarded in the biological sciences (National Research Council, 1969~; by 1999 that number had increased to 5,600 (Sanderson et al., 2000~. In the past 20 years the advance of Ph.D.s into disease-oriented research has increased dramatically. In 1997 "the majority of principal investigators for clinical research projects supported by the NIH and me Agency for Healthcare Research and Quality held Ph.D.s (1,449) rather than M.D.s or M.D.-Ph.D.s (1,061~" (National Research Council, 2000, p. 42~. Despite the impressive numbers of Ph.D. scientists available to per- form clinical research, the development of training programs that specifi- cally prepare basic scientists for clinical research has been sporadic. Be- fore 1980 there was practically no systematic instruction of basic scientists in disease-oriented research. In 1980 Harvard Medical School began offer- ing a one-semester course in organismal physiology and disease mecha- nism to basic science students (Arias, 2003~. During the 15 years between 1984 and 1998, 214 predoctoral students, and postdoctoral fellows, and faculty participated in the one-semester course. In 1984 Irwin Arias began training basic scientists at Tufts University in pathobiology as part of an effort to bridge the gap between basic science and its application to medi- cine (Arias, 1989~.