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~ # 2: _~ Ce ~ ~ ~ ~ ~ s e e e e ~ ~ e s e e e e e e e e e ~ e s e ^- e 51 G. ~ , . e ~ e e e e e e e e e e e e e e e ~e e e e e e54 Ce ~ e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e 57 Me ~ e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e e eS9 ( ~ ~) D ~1~ e ~ A. ~ls ~ ~e .61 50

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ENS AND SU~)RT EDR CLINICAL INVE~G~RS, Peat YANG INS lichens C. Origin A major problem today Is the need to erx~rage young clinicians to become clinical investigators. ~ the current ma of very rapid advar~ In fiu~bal r~r~ In biolo~i~1 science;. ir=ludir" _ , _ . . . . . . . Spicy, it is particularly important that the Unit Stat: have Native investigators to transfer biologic insights face the laboratory to the bride or In the clinic. Hey Chard be able to devise ways to get critical answers to the lions of the Cilia of new c3iagr~ic pry or i~rventive s~crategies. In recent years, led especially by the oncology and cardiology field, large scale Phase III clinical investigative efforts have appropriately begun to involve the statisticians in the --earliest possible phase of protcool design. In addition, Phase I and Phase II states quite appropriately deeply involve pharmacologists In the former, and statisticians in the lather, to det ~ e the best dosing strategy for nulLumlm toxicity and nE~cu~lm efficacy. by working with these other individuals and having the responsibility for developing the best overall developmental scheme for drugs, clinical investigators have developed a professionalism in the therapeutics area. The general clinical research center can be an ideal setting for Phase I and Phase II therapy studies. Phase III studies should be conducted in other clinics and wards aimed tc ward the general staff managing The observations. in order to predict field applicability of the approach. The way to learn clinical investigation is for young investigators to be directly involved in both development and execution of specific protocols. This can be done in our first rate academic institutions Here there is an available team of miners for a given disease area Hose cc~et~ mans all He involved disciplines. me trainees ant teachers can work together to develop a protocol which answers the contemporary questions In any given clinical area. Hey can also work cogetner on exerting Asking protocols am planning subagent steps with i ~ try arm governmental Sponsors. m e training of fellows in this prcg~m should be for at it two years to allow them to obtain a full insight into a complete cycle of prokoool conception, formulation, execution and analysis. . . . . Such train Meg programs can be financed by Elton industry or government, or most likely, a combination of the two. In order to give maximum future fiex~bi~ity and scientific rigor, it could occur after a period of bench research training and be acccmpanied with relevant university course work (statistics, experimental clinical trial design, etc.), as well as active series of semirn~s and jar clads covering all activities In the disease area. 51

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New on the scene a ~ consortium groups that r ~ resent institutional centralized efforts. - ~ ~~ ~- control programs. For example, the Eastern sores Tumor Group, the leukemia Task Force B. and recently, the AIDS Clinical Trial Group has been formed by the STAND. Specifically, in the AIDS Clinical Trial Grc up, a continuing effort is nrxur~31 at a nationwide level and involves many institutions, ~ gs and individual protocols. Young investigators can play critical roles in thump efforts and learn skills that they can take to future academic or industrial positions. multi Some of these are the varies s cancer Tb note this career track attractive on a long term hands, institutions nest recognize this discipline with tenure commitments to the best indivi~uP~s, which provide stability for those who make long term commitments to the area. This, In burn, requires stable governmental an4/or industrial support. We must recognize that encouraging develcpment of specialized centers of ex~1lenoe requires giving investigators the tools they need to get the answers to the problems they Purdue. Industry also must be willing to fund certain costs for the clinical trials, above and beyond the cost of producing material for study, and The specialized observations of efficacy or toxicity that are required in the care of the patients with the disease under soupy. Funds to assist in training, support for atbendin7 meetings, sell publicized prizes for investigator excellence, and endowed professorships, will all help to maintain the durability of the career pathway. m e NIH must recognize that they must also support certain large scale trials or RDl's in the clinical investigative area if we are going to provide our citizens with the test medical care. Me can ace when there is a national threat such as AIDS, the Penance swings toward cooperative group networks. One can then rapidly get comparisons between drugs, standardized schemes of drug development, and Lnarelse speed of data acquisition, whether a new agent comes originally from the smallest academic laboratory or the largest multinational drug cc mpany in the world. For some areas, the issue may be the need for more technology transfer from the area of basic science within the traditional disease area. Because a given area is out of favor, industrial support may be lagging, and yet the science is compelling as it has been recently in the vaccine area. Strategies such as the RDl mechanism can then be used for single or even multi-center (consortium) studies. Considering such applications would be difficult for the usual NIH study sections which are perhaps sometimes oriented toward study of biologic or disease mechanisms rather than clinical trials. We could set up new initial review groups to critique applications involving study sections with The prc per balance of medicine, biologic, statistical and pharmacologic expertise to really prioritize such studies among other applications. It is especially important for the NIH to recognize good young individuals who are committed to and productive in the area of clinical trials through RCDA support. This would allow them to concentrate their efforts in The area and obtain their final training. It will also be important both to devise specialized training programs for the best 52

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centers ~ this area, as well as having individual fellowship support mechanisms available nationally to support this effort. In order to support the highest quality of medic investigation, grant mechanisms rather than the complicated contract mechanisms are the appropriate conduit for funding this work. Either cooperative groups or RD1 grants can be used den there are agate review mechanisms. Finally, if we are going to concise to have fb~nta1 redry, which Is critical an offering near options for this kind of technology transfer, then we mast vicar this clinical r~r~ as camplenenting and not competitive with basic work. The clinical r~r~ field has been d~elc~pi~ its awn duplexity whit lo be ~s~ }fly the public, acerb, ad the hectic scientist. Clinical investigators must gene Cartable and develop an appropriate dialogue with all of the s~pporti~ groups. me public may think that only the original fatal finding or the final definitive clinical trial Is crucial. ace, the Cole chain of work that leads to an effective clinical approach must be credited by those So are describing a*varx:~ if the public as to obtain an idea of the teal effort. Hen they will understand that all a ~ are ~ y if we are to main al r preeminence In the field of medical research. Then technology transfer can be supported wish the additional funding it requires in this era of Diminishing available resources. . . 53

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IN CLINICAL INVE~G~ON David G. Nathan Ambles Bi~ical r~r~ Is divide into patient r~ated r~r~ that can be carried Ant only by Physicians or, to a limited ~tent, by the And and h~:ic ~a~h that can be perform by those holding either ~ _ . . the M.D. or Eh.D. It Is clearly Ant that a career in bi~i~1 r ~ has blimp a de ~ sing Option for me~;~1 school grad ates. During the past twenty years there has been a decline On first tine RD-1 applicants by M.D.'s, and a marked rise in applications submitted by Ph.D.'s. The M.D./Ph.D. applicant pool is so tiny as to be negligible. The training grant mechanism, which widens the opportunity for M.D.'s to become grant applicants, is 1e~c successful In inducing such trainees to apply for grants than is the fellowship program. miS is probably an artifact created by the fact that it is necessary to make a more specific choice about career in order to obtain a fellowship. But the two years of trainer supports by the trains grant mechanism are insufficient. Unpublished data by NIH clearly demonstrates that at least four to five years of training are necessary to produce an investigator who can successfully gain an NIH grant in tcday's competition. Burdened by debt and concern about future funding, young physicians are turning away from the careers that seemed so promising for graduator of the 50's and 60's. Recently, the NIH has developed five yeas physician-scientist, clinical investigator and academic investigator awards to complement the traditional research career medical awards for medical school graduates, but the funding for these awards is limited. In 1985, 769 physicians were being supported for further training by theme mechanisms. Even when fully developed, these programs will support only about 250 physicians each year, far fewer than the necessary l,OOO physicians trained well enough to compete in The research arena and prepare to fill the vacancies that are created in medical school faculties by retirement and attrition. In addition to insufficient length of braining, several other factors inhibit the successful development of a group capable of maintaining U.S. strength in patient related (clinical) investigation. 1. RU1~C and regulations involving Investigation of new drugs are complex and ponderc us, and the interaction of conservative drug companies with FDA regulators can be stultifying. Indeed, investigations of new Therapies in children are nearly impossible to carry out in the present climate. This discourages pediatricians f' m`' careers in clinical investigation. 54

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Clinical ~ assenter begets are s;hrinkir~ to the port at rich this important ~i~ of sort Is Firm nearly infusible to utilize. It ~d be far better to close scan He's arm distribute their begets to others than to starve all of ~em. 3. Hospital Begets are in such serials disarrays, particularly in OCR for page 50
His will pity And to a Din ~ ~ ~ of promos, but an increase In tlmi~r Halite. Whey shyly be well f so that fellows; can be reasonably support with wages sufficient to Rae me ravages of ~ and Dry ~ conic of ray I;,. ~ , Sup a program will be criticize because ~ Gerard will ~ to be awarded to institutions ~th already< large arm songful biblical and clinical r~r~ promos. Therefore, tic distribution will be I~= important tan qualify distribution, but it will be nPr~c=~y to face such an action if we are to preserve Hollers at a tone Hen purchasing pot will be maintained only with heroic effort. The business community, particularly the pharmaceutical industry, can make a major contribution to such a program by adding to fellowship stipends in the designed training centers that are producing the nP-==c~ry personnel, including investigative nurses and data managers so nPr=~c~ry on modern clinical investigation teams. . . . . ~ Conflict of Interest . Clinical investigation demands complete objectivity on the part of investigators, but successful drug development can be highly lucrative. This can lead to a serious conflict of interest, particularly if the clinical investigator has a financial stake in the cu~oome of his or her investigation. Therefore, it should be understood that an investigator of any drug or device must not hold a sianificant eouitv Interest in the company manufacturing such a device. _ ., ~ ~ ~ Patients must be considered solely as patients and not as objects that advance the equity ncsition of physicians. _ ~ . _, ,= ~ Fee for service is a time honored and ~ approach to rein for ~;~1 care, but: there Is a major difference been the conic of fee for service and the holding of an eo,uity position. Patients are not part of a physicians' capital and muse never Hone so. 56

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TRaINING OF CLINICAL INVESIIG~IORS Carl C. Peak Selection of Candidates for Training in Clinical Investigation Strategies should be developed to identify candidates for training in clinical investigation who have a high-probability of surer (e.g., finishing training and initiating/sustaining clinical investigation careers). Experience in research tIainecahips in clinical pharmacology suggests that pre-tralning research experience, medical specialty board certification, advanced science degrees, and quantitative science backgrounds are characteristics frequently observed among clinical pharmacologists who are engaged in clinical investigation. FOCI ~ The training program director should be an established clinic al investigator with demanstrated skills in bcCh research and Beaching. The associated academic faculty should comprise scientists representing acknowledged skills in the areas encompassed by the program content described below. me faculty should be committed to comprehensive -education of trainees, not simply to the availability of "cheap lab help." - Program Content and Duration of Training While training should always be individualized, the trainee should expect exposure to certain generic skills in clinical investigation as weJ1 as specialized research skills inherent An his/her research area. Generic skills in clinical investigation include: experimental desigp/biostatistics/data analysis ethics of human experimentation and research ethics scientific writing and presentation general laboratory skills, including computing critical evaluation of scientific information me minimum duration of training in clinical investigation is two years; su~occc as a clinical investigator in competing for scarce research funds appears to increase for those who have undertaken more than two years of training. 57

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Ref~; 1. Peck, Oc, cat, JR: Ant status of clinical Pharmacology training In the Unit Sta0;. Chin Warm ]her 39:451-458, 1986. 2. I~tay, DC, Lucas, M, [evey, GS: A E - gram for training Eibysician-irwestigato~. J Mad Ed 57:602-608, 1982. 3. Idly, R. Ibis, JR, Lyon, MB: EXhxxltion for clinical i: An ex`~ri~ at be Uhiversi~ of Michigan. C1~ Res 36:21-32, 1988. 4. Tallarida, En, State, EM, .~nith, JB, Jab, IS: Acadeni~industrial fixative graduate program in clinical pharmacology. J Clan ~annac~ol 28:204-207, 1988. 58

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IN St~RT OF SIUD7F~ OF MAJOR MENTAL ILLNESS Part M. Pee Approximately one in five to one in six of ~ population suffer fern berate to severe ~nta~ disorders, teas" on rant c~:a Fran the epidemiologies cat~tment area (ECU) base on probability sample of 20,000 individuals In five U.S. cities. - - - - Major prearm; has been made In be last five to ten years In clinical neumscienoe ~r~. New sL~-utegies such as MR{t ~1' ~ arm Ear pro; have made emboss acivar~ arm promise major bras in ~=st~r~ir~ major frontal ilLrmss in the next decade. Very significant problems exist in licit urinal clinical investigation of patients with severe mental illnesses such as schizophrenia. _ _ care and the efficacy of therapeutic agents takes many weeks to be ascertained. Diagnostic related groups in psychiatry have very significant impact on inhibiting clinical research on psychiatric patients (Pincus et al., Archives of General Psychiatry 42: 627, June 1985). _ = ~ , Nature of the disorder reoulres lonq-term There exists little support for studies of inpatients with major psychiatric illness and a great threat exists for essentially eliminating long-term support with the developing cost containment Panic. NIH has CRC funded bed costs to the total of over 600 beds in the country. There is no equivalent in AD~MH~ for funding of bed costs for longitudinal research with patients with severe mental illness. Those places where some support is available, such as the V.A. and state hospitals, there are major problems in that there is a relative absence of researchers in those enviro ~ nts and the population is not typing of many patients diagnosed with major mental illness. Despite the major advances in neuroscience and clinical neuroscience, ALAMH~ funding did not keep up with NIH from 1970-82. ring this time there was approximately 75 percent increase in funded ROls at NIH and a 25 percent drop in funding at AD~MH~. In the last few years the AD~MH~ budget has kept pace with The NIH budget, although it ha not ~captu~d the loss of this past decade. These figures have been d<~ntec3 in APE Hoff Policy Eject Report. In summary, patients with major rental illness rewire Special longitudinal short for clinical research. Such clinical Era Is increasingly relevant given be advances in neuroscienoe, but there is a dearth of mechanisms currently and studies are in Teasingly threatened by cost contain Humanisms. 59

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- - - There is a major problem ~ the development of junior investigators in psychiatry. Cnly in the last 10-15 years has there been a significant emphasis in developing biologist research and its ~evarx:e. The average age of investigators supported by NIMH are in their mid-40s. Psychiatrists are principal investigators on only approximately one-third of all RD1-sponsored research at NIMH, with this fraction much lower among the== Ie~s than 35 years of age. the hesearah Career Development Award mechanism of NDMH has yielded a very major contribution to the pool of investigators studying major mental illness as documented in a recent RAND Corporation study done for the NDMH. Neverthele==, there remains a great shortage of adequately supporbe] psyc hiatric im~estigators available to continue the clinical neuroscience rearm for major mental illness. Serials thought must be giver to devela ping scan lor~-term Manic of support, similar to Me strategies use in supporting investigators for lord periodic of time In sting disorders of Me heart and In cancer research. Referents Pints, H.A., West, J., and Goldman, H. (1985): Diagnosis-P~elated G~p6 and Clinical Pearl ~ hiatry. Arch. Gen. Psychiatry 42:627-629. r~ on Ante Ills and Addictive Disorders: Ells and fits. (1984) A Purport by ff1e lard on Mental Hearth and Behavioral Medicine of the Instill of Medicine. National Academy less, Warn, D. C. 60

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THE EUIU~ OF CAL INVE~G~ON Barry ShenEm (s~i~ with me corona= of Avid W. Martin, Jr.) Concerns for me fire of me clinician investigator are not new. PA discussions have f~ on the now to enrage and sustain me development of physicians who are also highly sc~histicate~ laboratory scientists. These discussions have identified several problems: 1. The need for in-depth post residency/fellowship Training and the lack of sufficient funds for such training. 2. 3. 4. The ambivalence of many, who at the end of their complete clinical training, foresee the need to embark on the necessary additional years of training in laboratory science. The uncertainty engendered by the prospect of a career of self-susbained research funding via grant applications in an increasingly competitive environment. The need to balance the demands of time for serious research against demands for patient care and teaching in an academic setting. Consideration of these issues has resulted In new NIH funding programs such as The Physician Scientist Program, but no one has addressed the fundamental questions; perhaps because there are no ready answers. Mach less attention has been given to The fate of the physician scientist involved in patient-oriented investigation. Here the problems are even more serious because they involve not only issues of training and its funding, but perceptions of the relative 'value" of scientific endeavor within an academic community. Since only a physician can conduct human investigation, it is paradoxical that the path to such a career is even more cicuded than it is for the individual committed to purely laboratory science. Today there are few, if any, training programs designed for the individual who wishes to carry -out human investigation, and not unexpectedly, there is ,: me, ~ hi_ ~~ ~ - ma: ~ =~ ~ - _= ~ _~_~_1 _ _ ~~_~ ~1 ~~ W ~ '~ -= =~1 ~ ~G=~1~U~- It is essential to understand that in 1988 it is effectively impossible for an individual investigator to obtain NIH funding for human investigations. Thus, it is impossible for an individual with such interests to foresee a crier of self-sustained funding through The grant mechanism. Lack of available funding makes these physicians Marc valued in the academic marketplace so that He individual interacts in a car in hen investigation carrot look for to a position in academic medicine in Be traditional sense. 61

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Trays situation is very illogical. It may be time to recognize that for most people a medical education, residency, and fellowship training is not the most logical path to a career in fundamental science. It is equally illogical that we have surnamed in eliminating the clinical research physician in the United Stages at a time when his/her role may never be more important in bringing the advances of the anew biology"' into the arena of medical care. m is is not the situation in Europe or Japan where the physician engaged In the study of human physiology, the pathogenesis of disease, and the eve of new therapeutics is productive and highly regarded. It is important in this regard to recognize that the role of the physician engaged in human studies is much broader than conducting randomized clinical trials. For the Physicians who Graduated following World War II. it was ~ _ _ , possible to move from a met education to a career In academic medicine that included a strong participation in laboratory science, as well as bedside investigation. his was made possible through clinical fellowship training programs that included both specialized clinical training, as well as laboratory research. With time it was recognized that many trainees evenly chose a career in clinical practice and that it was no longer neo~;C~ry to train large numbers of highly skilled sub-specialists, that the research of such individuals was often derivative and that Their scientific training was inadequate to sustain a long career in productive laboratory investigation. While the clinical fellowship of the past had many deficiencies, it did produce numbers of highly motivated young physicians trained in laboratory methods and issues of the time. These individuals participated in productive research for a varying number of years, perhaps moving freon laboratory-based to bedside based research or assumloq other roles within the academic medical cater. We now need to recognize that in denting with the inadequacies of clinical fellowship training programs, we have narrowed the entry path to those few physicians willing to study for a second career and accept the risks of the granting mechanism. The current situation demands re-exammation of the need for physicians in the clinical research process. If the judgment is Cat there is a vital role for the clinician scientist, then new programs must be developed to adequately train them and fund their work throughout an academic career. 62

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En: ~ OF PASCAL INVE~GA=RS Paul D. Stolley one of He reasons pos~a~ to account for He declining success of M.D. investigators In c~ainir~ NDl-funded grants is Heir lack of training In Used mete - c as contrast to Ph.D. i~nresLigato~ Pro do rat spend so Nash tine 1~ clinical n ~ icine). While there is not enough evident e at present to determine whether or not a deficiency of research methods training truly is an important factor in the decline of the sure in clinical investigators obtaining grants, there is information as to the reasons why grants are not awarded by NIH. The main reasons for the turndown of grants include the lack of specificity and originality of the question fs) being poses, inappropriate measures, inadequate statistical analysis and other reasons relating to insufficient training and competence in research method. The training of clinical investigators most include a transmittal of knowledge about research methods and a mastery of certain epidemiologic~1 and statistical techniques and skills. For example, whether or not to employ a randomized controlled trial or a non-experimental design; attention to adequate sample size and sampling methods; the need for a control group and other fundamental concepts must be taught clinical investigators if They are to compete successfully in obtaining grants. Sophisticated statistical methods are not the issue here, but rather the ability to reason statistically and to understand the basic uses of the varicus research strategies is more to the point. Statistics and epidemiology are user try allotted a brief time in the medical school curries Sum and taught early in The 4-y-~r course, when it is tech appreciated. me beginning investigator or Fellow In training About to start his or her research is better motivated to learn statistics than is the first year medical student who is not quite sure how relevant the subject will be to their future work. Courses in research methods Fond experience in protocol design should be considered an essential component of the post-graduate fellowship training of persons training for a career as an investigator, whether the type of investigation pursued is "basic," "applied," or "clinical;" whether they involve human subjects or experiments animals; and whether the object is survey research or an experimental study. The history of medicine and therapeutics is replete with premature advocacy and acceptance of therapies and theory due to inadequate understanding of research methods, the "rules of evidence" and epidemiologica~ analysis. Example include the use of DEN; In prier - , gastric freezing for bleeding ulcers and Ibbo~my for schiz~nia. Bust improved teadhi~ of epide~niologima~ and statistical methods may impure the practice of medicine as well as the quality of research. 63

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Finally, any attempt to loon ye "rules of eviderxx" in the name of "ir~vation" or "productivity" ~ Id be looked on with say caution and suspicion as the alleged ~nc'Dic justification may be hard to sustain after careful songbird. 64

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IlIE SUED AS A CLINICAL 5 Sahel A. Wells, Jr. It he been rat - 1y emphasized Dab ~ role of he clinician biblical rearm has been dim~i~i~ aver the last ~ decades. there are teeny reasons for this, ranging frmn he di~pr~ortionat-ly cI~l support f``AU me f"3era] govern for health relay remark arm Revert, as <~1 to that for defense and space, to the fact that me Cal pro and career goes of ~ay's graduating medical students and clinical residents have substantially Hanged foxy what Hey way even a few year'; ago. There are su ~ antial data to than not only that the constant dollars appropriated by Congress to the Naticnal Institutes of Health (NIH) actually decreased from the mid 1970s to the mid 1980s, but also that clinical investigators competed for these dollars 1e~c well than did their colleagues in the hectic sciences. abet clinical scientists have had their primary training in either internal medicine, pathology or F=~;atrics, and it is assumed by many that the current plight of the clinician investigator only applies to individuals in these specialties. m is of course is not the cane, but it Is clear that investigators in surgical disciplines have become minor ~ ~ ~ ~ ~~ be players In Inks arena and there are several ways in which this can documented. In 1987, the NIH awarded 21.5% of its total extramural budget for research grants to departments of internal medicine of medical schools. Departments of surgery, excluding ophthalmology and otolaryngology, received 10.5% (1). By 1982 the proportion awarded to departments of internal medicine had increased to atmcst 27%, while that awarded to departments of surgery decreased to 5.1%. A rather simple indicator of this reduced research effort is the number of articles in scientific pericdi~als that cite sources of financial support for the reported investigation. Citations in surgical journals peaked at 40% in 1970 and decreased to approximately 25% by 1980 (2). An a recent review of research in surgical oncology, Avis and associates (3) analyzed data concerning grant applications submitted to and funded by the National Cancer Institute (NCI) during the time period from 1980 to 1985. Of the total number (6407) of grant applications submitted, 44% were from departments of internal medicine, while only 16% were f call departments of surgery and 4% were from departments of obstetrics and gynecology. The success of grant applications (awarde4/submitted) frum departments of internal medicine, pediatrics 65

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an] radiology ranged four 34% to 36%, while the sum~=C=-c of grant applications submitted by departments of surgery and obstetrics and gynecology were 25% and 26% respectively. In evaluating trends during the six year period, it was evident that by 1985 the number of grants submitted by departments of Internal medicine increased 55% (363 to 566), while grants submitted from departments of surgery had actually declined 17% (203 to 168). In reviewing the sumacs= rate of grant funding by department, it was apparent, with the exception of radiology, where the percentage of such applications increased (34% to 37%), that such rates of all other departments decreased, with a disproportionate decrease in surgery, obstetric and gynecology: internal medicine (37% to 34%), pediatrics (42% to 34%), surgery (31% to 19%), and obstetrics and gynecology (39% to 15%). In considering all grants submitted to the NIH during the same period, similar patterns of grant submission and success rater were seen indicating that the problem was not specific to the NCI. It is alarming that clinical investigators in all fields of medicine are having trouble gaining research support from the federal government, however, the problem in the surgical specialties is critical and becoming worse. It is tempting to blame the scientific community generally and the NIH and other funding agencies specifically for this dilemma, but these grcup6 are not what is wrong with surging research and we should examine the reasons why academic surgeons have submitted fewer grants and have failed to get them funded. We can then consider what corrective action should be taken. It takes five years to complete a general surgical residency and an additional year if one pursues a fellowship in vascular surgery, transplantation surgery or critical care. If one wishes to be trained in cardiovascular surgery, plastic surgery or pediatric surgery, the fellowship pro grams are two years in length and there is a trend for many of these specialties to inch their training prc grams to three years. It is easy to sac why a surgical resident might not wish to spend one or two years in the research laboratory, especially if the clinical training program is to be seven or eight. years in length. Many pro gram directors who require that residents spend time in the laboratory have problems deciding the best time for this experience. Incest program are structured so that Me surgical resident takes time axt for research after ho or three yours of residency, arx} al~a2gh many are productive during this time, they lose contact with the laboratory Men they return to the residency for several more yews of clinical training. Mast surgeons, including those in a~=de~nic medic centers, are active clinically and because the performance of operative procedures and the care of patients thereafter are time consuming, and also because surgeons have other administrative and beaching duties, they have less time to spend in the laboratory than do their colleagues in most other clinical disciplines. A seemingly simple solution would be for surgeons 66

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to *he their life style ark not Bate so that they might have time for laboratory Beard. Indeed, scan surgeons have dbar~oned clinical surgery al~geff~er. while this might have its Russ, these individuals Fly fire thrives extra bed ream their associates and their specialty. Rueful surgical investigators are able to balance the laboratory and the clinic, but almost uniformly rhea- are surgeons who have spent substantial tine in basic laboratory research, usually Mu ring the residency years, so that they are well prepared to compete for peer reviewed research funds when they join a medical school faculty. Medical school is very expensive and most students incur substantial debt before graduating. In 1986, the average indebtedness of the graduating senior at the Washington University School of Medicine was $38,000, and by 1988 it had increase] to $45,000. Even if students choose surgery, or a surgical specialty for a career, many will not wish to spend tine in the laboratory because they do not want to delay their training. Most graduating surgical residents (even many who have spent time in the research laboratory), find the life style and financial rewards of private practice too enticing. mis is not difficult to understand considering the societal pressures that exist today. What can the academic surgical community do to attract highly talented persons into surgical research? There are three key considerations: 1. m e American Beard of Surgery and the surgical specialty boards must reconsider the stnlc~ of they residency programs. Rather than continue to lengthen the number of years required for training, it should be possible to decrease them. me American Board of Surgery requires five years of residency training (four of which must be spent in clinical surgery). Residents wishing to pursue training in cardicthoracic, pediatric or plastic surgery should need only four years,; or in some cases three years, of general surgery clinical training before entering these specialty residencies. m is will be a very controversial matter for the boards to deal with, but it is an obvious way for programs to provide residents an experience in laboratory research without adding years to the training program. the fact that the federal government will almost certainly decrease funding for residency programs makes this proposed alternative more likely. 2. Brats of surgery must provide the nor at~Ehere Here residents can do research. This often means establi~hi~ ~ni~fi~1 collaborations wit colleagues In He basic science reperks or other clinical depar~ts Here residents can sky No or more years In the research laboratory acquiring the rosary educational and methodological skills. 67

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Resources must be provided for laboratory tra m ing. While the NIH provides support for laboratory training through individual and institutional national research service awards, few departments of surgery have been successful in obtaining them. The federal government should be encouraged to provide increased funding for training surgical investigators since without the proper environment and program structure, residents will not acquire the necessary skills and knowledge ham= to compete sur-=c~fully for research support. Also, academic deFartacnts of surgery must divert clinical resources for research training primary y through "seed moneys' for supporting the young surgeon after he or she has completed the training and is preparing to apply for funding flus the federal government or like sources. Surgical research has made and win 1 make viny contributions to clinical medicine. We must remember that without surgeons there could be no organ transplantation, coronary bypass surgery or joint replacement. m e surging community must develop a sense of purpose about training the next generation of clinical scientists and the demoting availability of resources make the task a formidable one. WRENCH 1. Surgery in the Uhi~ Sta;. A Spry Report of Me SO on Surgical Serving for the Unit Stab. Vol. II, American College of Surgeons ark1 Me American Surgical Association, Chicago, pp. 1437-1691, 1976. 2. Iron, J.C.: The Role of barb an the Surgery of Tearer. American Journal of Surgery, 147:2-8, 1984. 3. Avis, F.P., Ell~rg, S., Fri~n, M.A.: Surgical Logy P~r~. Annals of Surgery, 207~3~: 262-266, 1988. 68