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Is the Crisis in Clinical Research Being Effectively Addressed?
  1. Patricia J. Byrns,
  2. Eugene P. Orringer
  1. From the Divisions of General Internal Medicine (P.J.B.) and Hematology/Oncology (E.P.O.), Department of Medicine, University of North Carolina, Chapel Hill, NC. This work was supported in part by the following National Institutes of Health grants: M01 RR00046, K30 HL04127, K12 RR17667, K12 HD01441, and K12HD052191.
  1. Address correspondence to: Eugene P. Orringer, MD, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, 126 MacNider Building, CB# 7000, UNC Campus, Chapel Hill, NC 27599-7000; e-mail: epo{at}medi.unc.edu.

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From 1979 to 1999, we were warned repeatedly by many of American medicine's best known and most respected leaders of an impending “crisis” in clinical research. Data were provided to indicate that both the number of physician-scientists actively involved in the conduct of clinical research and the number of young people choosing to pursue careers as clinical investigators were clearly dwindling. Although that may have been true in the 1980s and 1990s, many of us have become increasingly optimistic about what appears to be occurring in the first decade of the twenty-first century. Data now suggest that many of the efforts designed to develop young physician-scientists are starting to reverse this decline. As indicated in their recent report, Drs. Ley and Rosenberg observed an uptrend in the number of first-time MD applicants for National Institutes of Health (NIH) grants.1From approximately 750 to 800 in the period from 1995 to 1999, they noted a steady increase in first-time MD applicants over the ensuing 4 years, reaching a peak of 995 applicants in 2003. Similar increases were also found for first-time MD-PhD applicants during this same period. They also observed an impressive increase in the number of R01 applications submitted by MDs (an increase from approximately 3,000 in 1998 to 4,409 in 2004), as well as for MD-PhDs (an increase from approximately 2,200 in 1998 to 3,859 in 2004). All of these numbers had not changed or actually declined during the preceding 5-year period (1995-1999). Although Drs. Ley and Rosenberg did not discriminate between clinical and nonclinical applications, the article in this issue of the Journal by Kotchen and colleagues does just that.2Furthermore, their data in Table 2 show that when compared with 1994, the number of clinical research applications in 2004 rose from 4,126 to 5,813, a …

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