Resources for Clinical Investigation Report of a Study (1988) / Chapter Skim
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Position Papers on Issue 2: Training and Support of the Young Clinical Investigator in the United States
Position Papers on Issue 2: Training and Support of the Young Clinical Investigator in the United States
Pages 50-68
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From page 51... ...
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.
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From page 52... ...
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.
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From page 53... ...
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.
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From page 54... ...
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.
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From page 55... ...
therefore, a national training program that produces approximately 1,000 trained clinical inve ~ igators per year should be developed, and each trainee should receive five years of experience in investigation during the Training period. This five year period should include at least one year of clinical specialty training since it is impossible to develop clinical investigators absent knowledge of the clinical specialty involved.
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From page 56... ...
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.
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From page 57... ...
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.
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From page 58... ...
Ref~; 1. Peck, Oc, cat, JR: Ant status of clinical Pharmacology training In the Unit Sta0;.
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From page 59... ...
. _ = ~ , 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.
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From page 60... ...
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]
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From page 61... ...
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.
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From page 62... ...
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.
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From page 63... ...
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.
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From page 64... ...
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.
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From page 65... ...
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.
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From page 66... ...
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.
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From page 67... ...
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.
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From page 68... ...
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.
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