JULY 1996

PHARMACOEPIDEMIOLOGY AND DRUG UTILIZATION

Survey of clinical pharmacology training in the United States and Canada

A survey of 139 medical schools in the United States and Canada was conducted in 1993-1994 to determine where active training programs in clinical pharmacology were located. A secondary survey of clinical pharmacology program directors followed in 1994-1995. Thirty-nine active programs were identified where 113 fellows (84 physicians and 29 nonphysicians) were enrolled. Sixty-eight percent of current physician fellows were trained in internal medicine before they entered their clinical pharmacology program. Forty-four percent of trainees were reported to be U.S. citizens. Fewer than 20 fellows complete training each year. The reported content of training programs was 12% didactic, 72% research, 12% clinical service, and 9% supervised teaching. Funding sources for trainees varied considerably. Nearly 50% of trainees were supported all or in part by funds from the National Institutes of FIealth (NIH), and approximately 40% relied on international sources of support. No correlation between salary and funding source or fellow degree was found. Nearly two-thirds of recent program graduates obtained employment in an academic setting, whereas 15% entered the pharmaceutical industry. These data indicate that sub- specialty training in clinical pharmacology is available at 39 medical schools in the United States and Canada. Current fellowship training is primarily research based and nearly equally supported by NIH and international sources. (Clin Pharmacol Ther 1996;60:1-7.)

Louis R Cantilena, Jr., MD, PhD, and Raymond L. Woosley, MD, PhD Bethesda, Md., and Wasbingopz, D.C.

From the Division of Clinical Pharmacology, Departments of Reprint requests: Louis R. Cantilena, Jr., MD, PhD, Division of Pharmacology and Medicine, Uniformed Services University of Clinical Pharmacology, Departments of Pharmacology and the Health Sciences, Bethesda, and the Division of Clinical Medicine, Uniformed Services University of the Health Sci- Pharmacology, Department of Pharmacology, Georgetown ences, Bethesda, MD 20814-4799. University Medical Center, Washington. Copyright 0 1996 by Mosby-Year Book, Inc.

Received for publication Nov. 7, 1995; accepted March 14, 1996. 0009-9236/96/$5.00 + 0 13/l/73931

2 Cantilena asd Woosley CLINICAL PHARMACOLOGY & THERAPEUTICS

JULY 1996

In the last several years the field of clinical pharma- cology has advanced as a more well-defined discipline in the medical sciences. The American Board of Clin- ical Pharmacology was formed in 1990 and issued its first certifying examination in the specialty in May of 1991. Since that time, more than 200 individuals have been certified by this Board. The process of Board certification codifies the recognition of a body of knowledge that is requisite for a medical specialty. Formal training in clinical pharmacology in a univer- sity setting in the United States can be traced back to the 1960s. Surveys of clinical pharmacology training programs in the United States were published as early as 1973.i A current listing of training programs such as the Peterson’s Guide to Clinical Pharmacology Training Programs2 is no longer available as a resource for information concerning available clinical pharmacol- ogy training sites. This reference was last made avail- able in 1985, and according to the publisher there are no plans to resume its publication. The last published detailed survey of clinical pharmacology training in the United States was conducted a decade ago by Peck and Crout.3 The recent changes in the discipline of clinical pharmacology and the relative lack of recent data regarding the status of training programs were the impetus to reassess the availability of sites for training in clinical pharmacology.

The requirement for trained clinical pharmacolo- gists for roles in academia, industry, and govern- ment has been estimated by Brater.4 Formal train- ing in clinical pharmacology is now recognized as an important point of qualification for individuals seek- ing employment in the drug development industry and academia. Although formal recognition of clin- ical pharmacology by the American Board of Med- ical Subspecialties may be years away, certification of training programs by the American Board of Clinical Pharmacology is being initiated this year. This process will involve an assessment of individual program curriculum content, the credentials of the program director, and the quality of the training environment.

Individuals interested in pursuing formal training in clinical pharmacology currently do not have a published resource available to identify potential sites for training. This report summarizes a detailed survey conducted of U.S. and Canadian medical schools to determine the number of individuals be- ing trained in clinical pharmacology, the institutions where trainingis occurring, the type of training, and detailed information concerning current fellows in training. This report can also serve as a guide for

individuals seeking training in the United States and Canada in clinical pharmacology.

METHODS Two separate surveys were conducted to attempt

to capture a wide sampling of U.S. and Canadian schools of medicine and osteopathy and to subse- quently obtain detailed information about the exist- ing training programs identified. The first survey was initiated by mail and facsimile in 1993. This one- page survey was mailed to 139 Chairpersons of De- partments of Medicine in the United States and Canada and to 159 Chairpersons of Departments of Pharmacology or section heads of identifiable clini- cal pharmacology units. A total of 147 institutions were surveyed. Respondents were asked to indicate whether or not an active clinical pharmacology training pro- gram was in place at their institution and, if so, to identify the director of the training program. In addi- tion, the number of physician and nonphysician clinical pharmacology fellows currently in training was re- quested. Other questions asked concerned the number of fellows expected to complete training that calendar year. Finally, the respondent was asked to list all med- ically licensed clinical pharmacologists currently prac- ticing and teaching at his or her institution.

A second survey was sent by mail and/or facsimile to the individuals either identified as program train- ing directors in the first survey or who self-identified themselves to us as directors of clinical pharmacol- ogy training programs. This second survey was ini- tiated by mail, facsimile, or telephone during 1994. This secondary survey again asked for information concerning whether or not there were currently fel- lows in training at the institution and for specific information about the trainees. Respondents were asked to report the content of the clinical pharma- cology training program in percentages of time al- located for four specific training activities: didactic experience, clinical service, research, and teaching. Information regarding the history of training clinical pharmacologists at the respective institution was also requested. Specific background information about current fellows such as citizenship, type of training preceding the fellowship, the source of fel- lowship funding, and stipend amount was requested. Finally, information concerning job placement for recent program graduates was sought.

RESULTS Responses to the first survey were received over

an S-month period ending in March 1994. A 68%

CLKICAL PHARIv~COLOGY &THERAPEUTICS VOLUME 60, NUMBER 1 Cmatilena and Woosley 3

Table I. Survey of clinical pharmacology training in U.S. and Canadian medical schools

No.

Individuals surveyed Individual responses Institutions surveyed Institutional respondents U.S. medical schools reporting avail-

ability of a clinical pharmacol- ogy training program

Canadian medical schools reporting availability of a clinical pharma- cology training program

Programs with fellows currently in training

Current trainee information Physicians in training Physicians in training per program Physicians expected to complete

training in 1993 Nonphysicians in training Nonphysicians per active program Nonphysicians expected to com-

plete training in 1993

298 202 147 122 38

1

33

84 2.7*

13

29 0.9t 4

“Range, 0 to 13. tRange; 0 to 10.

response rate for individuals surveyed was observed. These responses resulted in an overall representa- tion of 83% of institutions surveyed in the United States and Canada. Responses were received from nine Canadian institutions and 113 U.S. institutions. Table I shows the tabulated numerical data from this survey. A total of 39 institutions reported that an active clinical pharmacology training program in place. A total of 113 trainees (84 physicians and 29 nonphysicians) were in training in the 31 programs that indicated they currently had fellows enrolled. Thirteen physicians and four nonphysicians were expected to complete their training by July of 1993.

A listing of institutions that reported they had an established program in clinical pharmacology in 1993 is provided in Table II. Table II also indicates programs that reported fellows currently enrolled in training. The Chairpersons of Medicine and Phar- macology and known section heads of clinical phar- macology units listed 253 licensed physician clinical pharmacologists who taught and conducted research at their institutions. These 253 academic clinical pharmacologists were located at 71 institutions. A total of 70 reporting schools did not have a clinical pharmacologist on staff.

A summary of the responses from clinical phar-

Table II. Listing of institutions that self-identified having a training program in clinical pharmacology, 1993 University of Arizona” University of Alabama” Baylor College of Medicine* Boise, Idaho VA Medical Center” University of British Columbia, Vancouver Brown School of Medicine* University of California San Francisco* Case Western Reserve University University of Colorado* Cornell University Medical College” Dartmouth Medical School Children’s Hospital, Detroit* Medical College of Virginia University of Miami, Florida Georgetown University* Harvard Medical School” Howard University Indiana University* University of Kansas Medical Center” University of the Health Sciences, Kansas City Louisiana State University Medical School Loyola University, Illinois National Institutes of Health, Bethesda” Robert Wood Johnson Medical School, New Jersey” Northwestern University* Oklahoma Medical Research Institute” University of Western Ontario, Canada Medical College of Pennsylvania University of Pittsburgh” Medical University of South Carolina”’ St. Louis University School of Medicine* University of Tennessee, Memphis* University of Texas, Galveston” University of Texas, San Antonio” Tufts University* Uniformed Services University” Vanderbilt University* University of Washington* Wayne State University

*Indicates programs that have current trainees

macology program directors is shown in Table III. Overall, an 88% response rate for this survey was observed. A total of 135 fellows were reported as “in training” in 37 programs. Fellows with a medical degree comprised 63% of current program trainees. The remaining 27% of current trainees held a PhD. Other reported degree backgrounds for fellows in- cluded the MD/PhD, the PharmD, and the MB,ChB degrees.

Regarding residency training backgrounds for physician fellows, Fig. 1 shows that 68% of current trainees had residency training in internal medicine

Cuntilena and Woosley

Residency Training by Specialty

1. The type of residency training specialty preceding fellowship in clinical pharmacology is shown. EM-MED, Emergency medicine; FP, family practice; GYN, obstet- rics and gynecology; IM, internal medicine; IM+sub, in- ternal medicine and subspecialty training; NEURO, neu- rology; PEDS, pediatrics; PATH, pathology; PSYCH, psychiatry; RADS, radiology; SURG, surgery; UNSPEC, unspecified.

of which 35% had also completed a medical subspe- cialty program before their current clinical pharma- cology training. Approximately 45% of current trainees did their residency or primary prefellowship training in the United States before starting their clinical pharmacology training. These percentages are similar to those reported for trainee citizenship. Forty-four percent of current fellows were reported to be U.S. citizens. The residency location and fel- low citizenship data was reported for 93% and 100% of current trainees, respectively.

The reported content of individual training pro- grams is listed in Table IV. The average content expressed as a percentage of the overall training experience for four specified training experiences for respondents was 12% didactic, 72% research, 12% clinical service, and 9% supervised teaching. Research training was the primary educational ex- perience for nearly all reporting programs.

The reported sources of funding for current fel- lows showed considerable diversity. Most trainees were supported by U.S. federal funds. Approxi- mately 44% of fellows were funded, either ail or in

CLINICAL PHARMACOLOGY & THERAPEUTICS JULY 1996

Table III. Summary of survey responses from clinical pharmacology training program directors

No. %”

Clinical pharmacology programs surveyed

42

Clinical pharmacology programs responding

37

Responding programs directed by a physician

37

Average of fellows entering each 2.31 program per year

Total of fellows in training 13.5 Trainee background by degree

MD 84 63 PhD 37 27 PharmD 3 2 MD, PhD 9 7 MB,ChB 2 1

*Indicates percent of the 135 fellows identified. fRange, 0 to 27.

part, by grants received from the National Institutes of Health (NIH). Nearly 40% of fellows were funded primarily from international sources, and 5% were funded by the Food and Drug Administra- tion. Other sources of funding included the Drug Information Association (one fellow), the U.S. mil- itary (two fellows), World Health Organization (one fellow), and hospital or medical school funds (20 fellows). Nearly one-third of trainees were sup- ported from more than one category of funding source. The average stipend for physician trainees was $29,565 per year (range, $12,000 to $55,000). For nonphysicians the mean stipend amount was $26,120 per year (range, $11,500 to $68,600).

Regarding past graduates of clinical pharmacol- ogy fellowships, programs reported that a total of 195 fellows had completed training in the preceding 5 years. Of these, 157 were physicians and 38 were nonphysicians. The distribution of initial employ- ment of the 195 fellows who completed training from 1989 to 1994 showed that the majority of grad- uates entered academic employment (66%) fol- lowed by industry-based employment, which ac- counted for 15% of graduating fellows’ initial positions. The remaining graduates took employ- ment in a private practice setting (12%) or a gov- ernment setting (4% nonmilitary or 3% military).

DISCUSSION This report summarizes the availability of clinical

pharmacology training programs located at medical

CLINICAL PHABMACOLOGY &THERAPEUTICS VOLUME 60, NUMBER 1 Cuntilena and Woosley 5

Table IV. Content of training programs reported by program directors

Type of training experience Responding training Didactic Research Clinical service Teaching

programs (%) (%) (%I (%)

Baylor College of Medicine Clinical Pharmacology State University of NY at Buffalo* State University of NY at Buffalo University of California, San Francisco Case Western Reserve University of Chicago University of Colorado Cornell University Medical College Dartmouth-Hitchcock Medical Center Georgetown University Howard University Indiana University University of Iowa

20 15 10 20 5

20 10 10 10 10 45 10 -

60 15 5 65 5 15 35 50 5

50-75 O-30 5 50 3.5 10 60 10 10 90 10 0 80 5 5 70 20 5 80 5 5 45 5 5 80 5 5

TNot specified) - Jefferson Medical College 5 80 10 5 Johns Hopkins University School of Medicine” 5 90 0 5

30% GTPCI 65% GTPCI 0% GTPCI 5% GTPCIT University of Kansas Medical Center 25 25 25 25 Mayo Clinic 5-10 84-89 1 5 Meharry Medical College 10 80 5 5 National Institutes of Health 10 75 10 5 Northwestern University Medical School 15 70 10 5 Oklahoma Foundation Cardiovascular Research 5 80 10 5 Ohio State University 15 50 25 10 University of Pennsylvania 5 90 5 0 University of Illinois College of Medicine at Peoria Program starts 1995 University of Pittsburgh 0 90-100 10 0 Medical University of South Carolina O-10 90 O-10 0 St. Louis University School of Medicine 0 100 0 0 Stanford University 5 80-85 5-10 5 University of Texas Health Science Center, San Antonio, Texas 20 60 10 10 University of Texas Medical Branch, Galveston, Texas 5 75 10 10 Tufts University School of Medicine 15 80 2.5-5 2.5-5 Veterans Affairs Medical Center, Boise, Idaho 10 80 0 10 Uniformed Services University 10 70 15 5 Vanderbilt University 5 80 10 5 University of Virginia Program discontinued Veterans Affairs Medical Center Boise/ 5 85-95 o-5 o-5

University of Washington, Seattle Wayne State University 20 65 10 5

Mean 2 SD 12 +- 9 72 2 17 12 i 12 9?9

*Identified hvo separate training programs. tGTPC1, Graduate training program in clinical investigation

schools in the United States and Canada and, in program information is the result of the relatively addition, provides the most recent available infor- high response rates for the sequential surveys de- mation concerning the numbers of fellows trained scribed. The survey of deans and chairpersons gath- annually in these two countries, funding sources for ered data from 83% of U.S. and Canadian medical these programs, and a description of the content of schools. The second survey, which asked directors of currently active training programs. The information clinical pharmacology training programs for data compiled for this work is fairly complete, if not concerning their program and trainees, had a re- nearly comprehensive. The completeness of training sponse rate of 88%. The combined survey response

6 Cantilena and Woosley CLINICAL PHARMACOLOGY & THERAPEUTICS

JULY 1996

rates result in a representation of more than 90% of medical schools in the United States and Canada.

A component of overall clinical pharmacology training that is not included in this survey is that which occurs in programs not based at an accredited medical school. Clinical pharmacology training at schools of pharmacy or hospitals not affiliated with accredited medical schools could have an active training program and not be represented in this report.

Since the report of a survey of clinical pharma- cology training by Peck and Crout3 in 1985, the number of active training programs in the United States appears to have remained remarkably con- stant. In 1984, their survey (53% response rate) identified 31 programs that had fellows currently in place.3 Our first broad-based survey identified 39 programs with fellows in place. Our second survey of program directors received data from 37 active pro- grams.

Program directors responding to our survey indi- cated that 19.5 fellows had completed training in the 5 years ending in 1994. Approximately a decade ago an estimate of 100 fellows completing training over 5 years was made by Nies and Breckenridge.’ The reporting base that afforded that approximation is not specified; therefore it is not possible to com- pare respective estimates of trainee output over time.

The reported curriculum for training programs in clinical pharmacology demonstrated several inter- esting points. Clinical pharmacology training is pri- marily research based. All programs included re- search training as a component, and more than 90% listed this category of training as the majority of the overall experience.

Of the 35 programs for which curricula data is available, 14% do not include clinical service and 17% do not include supervised teaching as part of the training experience. Specific program content was not reported in the 1986 survey.3

When comparing our results with the latest edi- tion of the Peterson’s Guide2 for training programs in clinical pharmacology (published in 1985), it would appear that the availability of sites where training is offered has decreased substantially over the past 8 years. More than 70 programs are listed in that reference. However, as noted in previous re- ports,3 listings in the Peterson’s Guide tend to over- estimate the actual number of active training pro- grams. Eligibility criteria for listing in Peterson’s Guide did not include a requirement for past or

current trainees in the program listed. The present report therefore should be most helpful in identify- ing where training is currently taking place and to generally describe the content of the respective training programs listed.

An examination of the reported sources of trainee funding shows that nearly half of current support is from the U.S. Federal Government. Ninety-eight percent of this federal support is through the NIH. Although the number of NIH training grants for clinical pharmacology has de- creased since 1985, it would seem that program directors are funding trainees through other fed- erally based means, which may include investiga- tor research grant awards.

The medical specialty background of current trainees is similar to that reported for practicing physician-clinical pharmacologists in the past. Our survey found that the majority of trainees are internists. An extensive survey of practicing clin- ical pharmacologists reported that the majority of physician-clinical pharmacologists were also in- ternists.6

The demographics of trainees with respect to cit- izenship may have changed slightly over the past 15 years. For the years from 1979 to 1983, approxi- mately 70% of trainees for whom data were re- ported were U.S. citizens.3 In contrast, 44% of cur- rent trainees in the present survey were reported to be U.S. citizens. However, direct comparison of these percentages must be qualified: the early citi- zenship data was derived from a survey of program directors from a then-current Peterson’s Guide,2 which had a 53% response rate.3

The number of practicing physician-clinical pharmacologists at academic medical centers re- ported in our survey was 253. A previous survey of clinical pharmacologist members of the American College of Clinical Pharmacology and the Amer- ican Society for Clinical Pharmacology and Ther- apeutics identified 310 individuals working in pri- vate or public academic centers.6 A direct comparison of these numbers is not reliable be- cause the reported information in the respective surveys differs.

True estimates of the needs for formally trained clinical pharmacologist are difficult to obtain. Ap- proximate manpower needs have been stated4 for various sectors of potential employment. Based on the stated need for 84 immediately and 20 to 30 per year, the current level of training program output (<20 per year) may not be adequate to fill the

CLIA-ICAL PHARNACOLOGY &THERAPEUTICS VOLUME 60, NUMBER 1 Cantilena awd Woosley 7

estimated ongoing need for fellowship-trained indi- viduals. Whether or not the estimate for need is still valid is difficult to determine. Recent mergers and downsizing trends in the pharmaceutical industry may have reduced the demand for trained clinical pharmacologists in that sector. These significant changes in industry and changes that are underway in government and academia prevent an accurate analysis of the current need for clinical pharmacol- ogists in relation to the current training program output.

In summary, 39 clinical pharmacology training programs are currently active in the United States and Canada and are funded from a variety of sources. The NIH represents the most common sin- gle funding source. Extrapolations regarding the match between future manpower requirements for the discipline of clinical pharmacology and the cur- rent training output are not possible because of the changes occurring in all sectors of potential employ- ment. The impact of changes in health care financ- ing and in the ability of government to continue to fund training may significantly alter program avail- ability in the coming years. A periodic survey of

training programs in clinical pharmacology may pro- vide a useful measurement of the current health and prognosis of the discipline.

We thank Cheryl Royce, BSN, RN, for her excellent assistance in data retrieval and organization for this project.

References 1.

2.

3.

4.

5.

6.

Survey of clinical pharmacology training programs in the U.S. and Canada. Bethesda, MD: American Society for Pharmacology and Experimental Therapeutics, 1973. Clinical pharmacology: a guide to training programs. 7th ed. Princeton, NJ: Peterson’s Guides, 1985. Peck CC, Crout JR. Current status of clinical pharma- cology training in the United States. Clin Pharmacol Ther 1986;39:451-8. Brater DC. Clinical pharmacology: where has the fund- ing gone? Clin Pharmacol Ther 1990;48:219-24. Nies AS, Breckenridge AM. Workshop report: clinical pharmacology teaching, training and career develop- ment. Clin Pharmacol Ther 1986;39:466-70. Wilson JT, Brown RD, Kimura KK, Whelton A. Profile of clinical pharmacologists in the United States. J Clin Pharmacol 1989;29:695-713.

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