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ISSUE 2: TRaINING OF THE YOUNG ~ CAL INVESTIGATOR IN qua UNTPED ACES There is increasing evidence that the number of highly talented individuals f ~ medical school and postgraduate residency training, and subsequently entering a career in clinical investigation is decreasing (1, 16-18). Simultaneously' there has been a relative decline ~ the proportion of the NIH budget devoted to training con pared with that committed to research projects (19). As many as 20 per Dent of clinical traineeship6 and fellowships have been filled by individuals with the ID. degree rather that the M.D. den (17). This is occurring at a Bone men ~;~1 enrollments are higher than a decade ago, and~en the exci~nt and challenge Fiats with clinical research has never been greater. ] ~ e Is legitimate con Bern that failure of young physicians to enter Into careers In clinical investigation will seriously impair our ability to translate what has been discovered in the preclinira1 setting into medical advances that can benefit mankind. There are a number of reasons why clinical research has lost a great dean of its appeal for physicians-~n-training. These include the large debt borne by recent M.D. Graduates, the discrepancy between the incomes of clinical investigators and their colleagues who have chosen to enter the practice of medicine, the increasing difficulty clinical investigators experience in getting funds for their research from NIH and other sources, and uncertainties about advancement in the academic community where accomplishments In laboratory research come sooner, and consequently, are often held in higher regard than those in clinics] investigation (17, 18, 20, 21~. In addition, one must add to this list the increasing length of time an individual must remain in tralnin9 to become an effective clinical investigator (20, 21~. This will also add to the financial burden felt by both the trainees and their families, and may very well cause an otherwise cutstanding candidate for a successful career In clinical res arch to enter the full t;~- practice of clinical medicine. Finally, it should be reccgnized that training programs in clinical investigation must enroll more individuals than may ultimat=1y continue Ln that career (22~. Prior to entering a rigorous training pro gram in clinical investigation, few individuals will truly know if they have the ability, interest, and temperament to survey as a clinical investigator. Good programs will give them the opportunity to make an honest effort to sur - con in The highly competitive and, at temper extremely frustrating world of the clinical investigator. 3See Appendix B: Rdrigan, p. 51; Nathan, p. 54; Peck, p. 57; Rose, p. 59; Sherman, p. 61; Stolley, p. 63; Wells, p. 65; and Halley, p. 70. 9

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Pccc~endations 1. The Program a) A national training program that annually produces app ~ truly 1,000 new, well-trained, clinic investigators ~ est;~at^~ to be ~ecP=c~ry to replace U.S. medical school fa4culty members who leave their investigative careers (21, 22). Each M.D. trainee should receive up to five years of experience (which follows the standard clinical residency training), p q from closely supervised training experience and moving toward increasing independence (20). This five-yea' period should include at Blat one year of clinical subspecial~y training since it is infusible to develop clinical investigators to lack ~wle~ge of the particular discipline involved. The pcetgraduate training period for the M.D./~.D. fellow may rewire a Shorter prior than 5 years (e.g., perhaps 3), one of ~ h dhomd include clinical specials training. b) National training programs are essential for clinical investigators In other heath professions such as rn~rsina. clinical psychology or dentistry. _, these programs Should prepare them to maRe scientific contributions to held care within their fields and behold include those ads of training described in rations 2-4 belay. 2. Methods of Training we ~craining programs behold include, in addition ~ ~ ortunities to mas ~ the P ~ a ~ t=1 biomedical science, design and responsible conduct of clinical trials, including a solid foundation in areas such as clinical trials methodology, biostatistics, clinical epidemiology and ~ reoemmendation refers to clinical investigation broadly defined on page 2 of this report, because these are the only data available to this Committee. We Institute of Medicines sty entitled Pensor~ Nets arx] Training for Bic~i~1 and Behavioral Arch (21) Animates that We Ate ~ of positions to bane available anally on clinical faculties of n~ira1 schools Art 1990 urger variants conditions ranges foxy a I~ estimate of 1,380 to a high estimate of 4,860 (this Aver includes only new hits or those So rejoin faculties freon temporary tours in government or industry and does not include i~rfaallty transfers. ~ . . 10

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clinical pharnac~ology. ~ additional, efforts mast be ~ to eriha.~e an aware of tee ethical, social and epic factors relay to clinical iTnrestigatic~n. 3. Financing a) NIH insti~ti~al clinical Beards training gray Ed combine arx] be ~ to be Be major fuming same for Off fires 3 years of this pr~3rmn. b) In saw Iowan, individual fellc~hipe may be unsized to sport the first 3 year';. c) In mist ~c, Be final 2 years; dhalld be competitively furx3ed tar a Mania similar to the NIH car develc~:s awards. d) Medicare Ed include, ~ its payment for hospital services, graduate maims education Arcs for Be tine that persons in fonn~1 clinical investigation training prawns Mend In direct straw patient care beyond the Reid residency year;. e) Pharmacautic~1 and med;~1 devices companies should continue and expand funding for training of clinical investigators. 4. Career Path Stabilization me clinical investigational trainee should be On a national s ~ that provides career stabilization an] secures ultimate entry into a Lruck toward tenure. me academic institutions and the Draining pray- dir ecUors should encourage and follow the trainees. Furthermore, they must be held accountable for this process at the time of peer reviewed renewal of the Fesearch Training Awards. 5. Data Collection there shawls be a national prawn to collect awe - riate data on clinics investigator training arm curs such as: a) Em of clinical irnrestigators in training as defined in Allis stupor; b) historic finding activity; c) pro~ctivity/publication crack Cords; d) demographics. 11