Campbell EG, Weissman JS, Moy E, Blumenthal D. Status of Clinical Research in Academic Health CentersViews From the Research Leadership. JAMA. 2001;286(7):800-806. doi:10.1001/jama.286.7.800
Author Affiliations: The Institute for Health Policy, Department of Medicine, Massachusetts General Hospital, and Harvard Medical School (Drs Blumenthal, Campbell, and Weissman) and Department of Health Care Policy (Drs Blumenthal and Weissman), Boston, Mass; and Association of American Medical Colleges, Washington, DC (Dr Moy).
Context The changing state of the health care system in the United States may
be adversely affecting clinical research conducted in academic health centers
(AHCs). Few formal data have been gathered about the nature and extent of
the problems facing clinical research or the effects of remedies undertaken
Objectives To assess the perceived quality and health of the clinical research
enterprise and to determine challenges and adaptations to current environmental
Design, Setting, and Participants Mailed survey conducted between December 1998 and March 1999 of a subsample
of department chairs and senior research administrators (SRAs) in all US medical
schools. Of the 712 potential respondents, 478 completed a questionnaire,
yielding an overall response rate of 67.1% (64.8% for SRAs and 67.8% for department
Main Outcome Measures Ratings of overall health/robustness of clinical research, quality of
research in 5 domains, extent of challenges to performing research, and sense
of urgency in responding to research challenges; formal strategies for research-related
tasks and their effects.
Results Slightly more than half (52%) of all respondents rated the health of
the clinical research enterprise as good or excellent compared with 63% for
nonclinical research (P<.001). Respondents were
most likely to rate nonclinical research as high in quality (79%) compared
with 70% for phase 3 clinical trials, 67% for translational research, 65%
for phase 1 and 2 trials, and 57% for health services research (for all comparisons
with nonclinical research, P<.001). Pressure on
clinical faculty to see patients was perceived as a moderate-to-large problem
for clinical research by the largest percentage of respondents (93%), followed
by insufficient clinical revenues (89%), recruiting trained researchers (75%),
lack of external support for clinical research (72%), competition from contract
research organizations (48%), problems introduced by the institutional review
board process (38%), and finding research participants (37%). In total, 81%
of respondents considered the challenges facing clinical research in AHCs
to be urgent or extremely urgent.
Conclusions Academic leaders perceive clinical research activities in AHCs to be
less healthy, of poorer quality, and facing greater challenges than nonclinical
research activities. Many AHCs do not have policies or mechanisms to address
challenges facing the clinical research mission. Even among those with such
policies, more than half do not believe these policies have had large positive
effects. Our findings support the view that the clinical research workforce
and infrastructure may need to be expanded and strengthened to keep pace with
advances in basic research.
Clinical research, defined as research that involves living humans as
subjects, is composed of a wide spectrum of research types such as clinical
trials, translational research, epidemiological research, health services
research, and outcomes research and is critical to translating the results
of basic science into useable health care products and services.1
The challenges facing the clinical research enterprise in the United States
have become major concerns of the academic medical community. One reason is
that these challenges could eventually reduce the flow of future medical knowledge
by inhibiting the amount or reducing the quality of the research conducted.2,3 Realizing this potential, the Institute
of Medicine recommended the establishment of a US $1 billion fund to incorporate,
rapidly and appropriately, the results of scientific research into clinical
practice—one of the causes of low-quality health care.4
Much of the "crisis" in clinical research has been attributed to numerous
changes in the health care environment.5- 7
First, insurers are less willing to pay the higher costs of patient care at
academic health centers (AHCs). Thus, institutions in highly penetrated managed
care markets have a reduced ability to cross-subsidize clinical research from
patient care revenues.6 Second, health plans
may limit the availability of patients to participate in clinical research
at AHCs by directing them to lower-cost providers8
or by refusing to cover the additional costs of patient care that occur as
a result of clinical research. Both of these actions could reduce the potential
supply of patients to serve as subjects in clinical research. Third, young
faculty may spend more time seeing patients to cover their salaries and generate
clinical revenues for their institution. This may explain why clinical researchers
in the high managed care areas have greater clinical care responsibilities
and have a reduced amount of research funding from the National Institutes
of Health (NIH).5,7 As a result,
insufficient numbers of trained clinical researchers are currently available
to meet the demand.9 Finally, AHCs now face
competition from nonacademic contract research organizations (CROs) to supply
clinical research services.1
In response, some AHCs have taken steps to support their clinical research
mission by streamlining the human subjects review process; improving the grant-writing
capabilities of their faculties; or assisting researchers to identify new
funding sources, establish collaborative relationships, and recruit patients.10 Unfortunately, empirical work is scarce regarding
the nature or extent of the problems facing clinical research or the impact
of the remedies AHCs are undertaking. Importantly, concerns about clinical
research are rarely viewed in a wider context, such as relative to the status
of nonclinical research.
One window into the world of clinical research in AHCs is the perspective
of research leaders, including senior research administrators and department
chairpersons in US medical schools. These individuals are likely to be close
to the research being performed but far enough removed to achieve a sense
of the problems and potential solutions occurring at departmental and institutional
levels. Therefore, we conducted a national survey of the research leadership
to examine the following questions: (1) How healthy are the clinical and nonclinical
research enterprises in US medical schools? (2) What challenges do medical
schools face in protecting their clinical research mission? (3) What strategic
adaptations are they using to protect their clinical research mission and
what impact have these adaptations had on the amount of clinical research
The sample for this study consisted of the senior research administrator
(SRA) and the chairs from 5 departments at each medical school in the United
States. Using lists from the Association of American Medical Colleges, we
identified the chairs of the departments of anesthesiology, internal medicine,
neurology, pediatrics, and psychiatry at all 122 accredited, allopathic medical
schools in the United States, excluding Puerto Rico. These departments were
selected because they normally represent the most research-intensive departments
in medical schools. Since not all medical schools contained all 5 departments
and some positions were vacant at the time of the survey, our universe of
department chairs was 587 subjects.
We also identified the SRA holding the title of vice, associate or assistant
dean for research, research administration, research affairs, or academic
affairs. For schools that did not have an individual holding one of the above
titles, we asked the dean to identify the person in his/her institution who
held the primary responsibility for planning and managing the research activities
of the medical school. For 3 medical schools the dean identified 2 individuals
as SRAs. Hence, our universe of SRAs was 125 rather than 122.
Our total sample consisted of 712 subjects (125 SRAs and 587 department
chairs). Among the department chairs, there were 110 chairs of anesthesiology,
123 chairs of medicine, 112 chairs of neurology, 122 chairs of pediatrics,
and 120 chairs of psychiatry.
We developed 2 survey instruments, 1 for SRAs and 1 for department chairs.
To determine important content areas, develop and refine our hypotheses, and
compose specific survey items, we held a focus group with potential respondents,
interviewed informed colleagues, and reviewed the relevant literature. The
instruments were pretested using 6 cognitive interviews conducted by professional
survey researchers at the Center for Survey Research at the University of
Massachusetts. The survey was administered by mail between December 1998 and
March 1999. Of the 712 subjects, 478 completed a questionnaire, yielding an
overall response rate of 67.1% (64.8% for SRAs and 67.8% for department chairs).
The Health and Robustness of the Clinical and Nonclinical Research
Enterprises. Respondents were asked to rate the overall health and robustness of
the clinical research in their department (for chairs) or institution (for
SRAs). Rather than supply a definition of health and robustness we allowed
the respondent to individually define these concepts, a procedure frequently
used in survey research. The response categories were "excellent," "good,"
"fair," and "poor." An identical question was asked with respect to nonclinical
research. For each question the responses were collapsed into dichotomous
variables with "excellent" and "good" coded as 1 (interpreted as healthy and
robust) and "fair" and "poor" coded as 0 (interpreted as not healthy and not
Quality of Research. Respondents were asked to rate the quality, on average, of research
performed in 5 areas: phase 1 and 2 clinical trials; phase 3 clinical trials;
translational research (research that explores basic biological questions
and uses humans as research subjects, often conducted in General Clinical
Research Centers); epidemiological, health services, and outcomes research;
and nonclinical research (ie, basic research). Response categories were provided
as "very high quality," "high quality," "adequate quality," "poor quality,"
and "none performed." The responses to each question were collapsed into dichotomous
variables with "very high quality" and "high quality" coded as 1 (interpreted
as high-quality research) and "adequate" and "poor" responses coded as 0 (interpreted
as less than high-quality research). Respondents who checked "none performed"
were coded as missing.
Challenges to Performing Research. Participants were asked to rate the extent to which each of the following
were problematic for clinical and nonclinical research: "the availability
of external research support," "recruiting trained researchers," "finding
research subjects," "pressure on clinical faculty to see more patients," "insufficient
clinical revenues," "competition from CROs," and "the institutional review
board (IRB) process." The response categories were "no problem," "small problem,"
"moderate problem," and "large problem." Again, the responses to each question
were transformed into dichotomous variables with "moderate problem" and "large
problem" coded as 1 (interpreted as a significant problem) with the "no problem"
and "small problem" responses coded as 0 (interpreted as not a significant
Urgency of Responding to Challenges. Respondents were asked: "Please rate your overall sense of urgency as
you respond to the challenges facing the conduct of clinical research in your
department or institution." The response categories were "extremely urgent—we
are in a crisis with respect to clinical research," "urgent—delays in
facing the challenges will be costly to clinical research," "not very urgent—normal
management will address our clinical research issues,"or "not at all urgent—there
are no important challenges to clinical research in my department or institution."
Strategic Adaptations. Respondents were requested to indicate whether their department (for
chairs) or institution (for SRAs) had formal procedures or mechanisms in place
(yes/no) to assist investigators with 6 research-related tasks: (1) identifying
funding sources; (2) identifying potential collaborators; (3) writing grants;
(4) reviewing grants prior to submission; (5) revising grants after a rejection;
and (6) recruiting research subjects. For each "yes" response, we asked, "What
has been the effect on the amount of clinical research performed?" The response
categories were "no positive effect," "small positive effect," "moderate positive
effect," and "large positive effect." Again, the responses to each question
were transformed into dichotomous variables with "moderate positive effect"
and "large positive effect" coded as 1 (interpreted as a significant positive
effect), and the "no positive effect" and "small positive effect" responses
coded as 0 (interpreted as not a significant positive effect).
Medical School Characteristics. The research intensity of each school was measured based on the amount
of NIH research funding awarded to each medical school in 1999. The medical
school that received the most funding was designated as 1 and the medical
school with the least funding was designated as 122.11
Similar to our previous work, each medical school was assigned to 1 of 2 categories:
high research intensity (the 50 institutions that received the most money
from the NIH) or low research intensity (institutions ranked 51 or higher).6
The competitiveness of the local market was indicated by the level of
managed care penetration in 1998, obtained from InterStudy.12
Each medical school was matched with the nearest metropolitan statistical
area for which information about the managed care penetration was available.
Respondents that could not be matched to a metropolitan statistical area were
coded as missing for this analysis. Similar to previous work, the managed
care penetration of each medical school was transformed into a categorical
variable with 3 groups: low (1%-20%), medium (21%-40%), and high (>40%).7
All analyses were conducted using SAS (version 6.12, SAS Institute Inc,
Cary, NC). Differences in simple proportions were tested using the χ2 test. Multivariate analyses were performed using logistic regression
controlling for type of respondent (SRA vs department chairs), research intensity
(high or low), and level of managed care penetration (high, medium, or low).
The regression formula was logit (pi) = β0+ β1X1+ β2X2 + β3X3, where pi is the probability of an event, β0 through β3 are regression coefficients for the independent
variables X1 through X3. Unless otherwise specified,
regression-adjusted percentages are presented using the logistic model specified
Initial bivariate analyses suggested a possible interaction between
research intensity and managed care penetration. Therefore, numerous multiple
regression models were performed for each dependent variable with separate
interaction terms for each combination of the research intensity and managed
care variables (high managed care and low research intensity; high managed
care and high research intensity; etc). However, in only 1 instance was the
interaction significant in multivariate analyses, and for that case results
are presented separately for high and low research-intensive institutions.
Also, a number of sensitivity analyses were conducted. We analyzed the
primary dependent variables as ordinal in nature and compared differences
in means; we included an additional variable in the multiple regression analyses
for department specialty; and we tested alternative dichotomization approaches.
The overall direction and significance of these analyses were similar to those
presented and are not included here.
Of the respondents, 92% were male, 89% were physicians, and 92% had
experience conducting clinical research (Table 1). Department chairs were more likely than SRAs to be male
(94% vs 82%), physicians (99% vs 39%), and have conducted clinical research
(98% vs 64%). Forty-five percent of respondents were employed in high research-intensive
medical schools and 55% in low research intensive schools. Of the respondents,
14% were located in low managed care markets, 55% in medium penetrated markets,
and 31% in high managed care markets.
Table 1 also compares the
distribution of the respondents with the nonrespondents in terms of their
research intensity and the level of managed care penetration. On both measures
no significant differences were found between respondents and nonrespondents
(P = .71 for research intensity and P = .98 for managed care penetration).
Slightly more than half (52%) of all respondents rated the health and
robustness of their clinical research enterprise as good or excellent vs 63%
for the nonclinical research enterprise (P<.001)
(Table 2). SRAs were more likely
than department chairs to rate the health and robustness of the nonclinical
research enterprise as good or excellent (85% vs 55%, P<.001).
Perceptions of the health and robustness of the clinical research enterprise
varied by the research intensity of the institution. At high research-intensive
schools, 72% of respondents reported that the overall health and robustness
of their clinical research enterprise was good or excellent compared with
35% in low research-intensive schools (P<.001).
A similar trend occurred for nonclinical research, although the percentages
reporting good or excellent were slightly higher in each category.
Perceptions of the health and robustness of the clinical and nonclinical
research enterprise also differed significantly by the level of managed care
penetration. Slightly more than a third (37%) of respondents in the low managed
care markets felt their clinical research enterprise was in good or excellent
health compared with slightly more than half (53%) of those in medium managed
care markets (P<.049) and 58% of those in high
managed care markets (P = .01). A similar trend was
shown for nonclinical research, but no statistical significance was reached.
As shown in Table 3, respondents
were most likely to rate nonclinical research as high in quality (79%) compared
with 70% for phase 3 clinical trials, 67% for translational research, 65%
for phase 1 and 2 trials, and 57% for health services research (all comparisons
with nonclinical research significant at P<.001).
For each type of research, respondents in high research-intensive schools
were more likely to feel that the research conducted in their department or
institution was of high or very high quality compared with respondents in
less research-intensive schools. For example, 87% of the respondents in high
research-intensive schools rated the quality of their nonclinical research
as high or very high compared with 65% of those in low research-intensive
schools (P<.001). Virtually identical patterns
of response were shown for phase 1 and 2 clinical trials (73% vs 56%, P = .002), phase 3 clinical trials (77% vs 63%, P = .002), translational research (76% vs 54%, P<.001), and health services research (68% vs 48%, P<.001). There were no significant differences by managed care penetration.
SRAs and department chairs differed somewhat in their ratings, with department
chairs significantly more positive about phase 3 clinical trials and SRAs
more positive about nonclinical research and health services research.
Respondents reported an overall sense of urgency with respect to the
challenges facing clinical research. Twelve percent felt that the situation
was "extremely urgent—we are in a crisis with respect to clinical research";
69% thought it was "urgent—delays in facing challenges will be costly
to clinical research"; and 17% "not very urgent—normal management will
address our clinical research issues." Table 4 shows respondents' views of the seriousness of the challenges
research leaders face. Pressure on clinical faculty to see patients was perceived
by the largest percentage of respondents as a moderate to large problem for
clinical research (93%) followed by insufficient clinical revenues (89%),
recruiting trained researchers (75%), a lack of external support for clinical
research (72%), competition from CROs (48%), problems introduced by the IRB
process (38%), and finding research subjects (37%). These figures are all
13 to 25 percentage points higher for clinical research than the comparable
figures for nonclinical research (P<.001 for all).
The problems of availability of external research support and the ability
to recruit trained researchers were most acute in the low research-intensive
institutions. For example, 81% in low research-intensive schools felt recruiting
trained clinical researchers was a moderate to large problem compared with
66% in the most research-intensive schools (P<.001).
The level of managed care penetration was associated with increased
pressures to see patients, insufficient clinical revenues, and competition
from CROs. In high managed care markets, 97% reported that pressure to see
patients was a moderate or large problem for clinical research compared with
90% in low managed care markets (P = .03). Similar
results were found for insufficient clinical revenues (93% high managed care
vs 80% low managed care, P = .01). However, a significantly
smaller percentage (66%) of respondents in high managed care markets felt
the availability of external research funding was a moderate or large problem
compared with 86% in low managed care markets (P
A significant interaction was found between research intensity, managed
care penetration, and perceptions of the seriousness of CRO competition. Among
the respondents in low research-intensive schools in low managed care markets,
29% felt competition from CROs was a moderate to large problem compared with
50% in medium managed care markets and 56% in high managed care markets (P<.001). There were no significant differences by level
of managed care penetration for respondents in high research-intensive institutions.
A number of potential strategic adaptations available to medical schools
to address the challenges facing the clinical research enterprise were addressed.
Sixty-nine percent of respondents had formal processes for assisting faculty
in identifying funding sources: 48% for identifying potential collaborators,
45% for writing grants, 45% for reviewing grants prior to submission, 34%
for reviewing a grant after a rejection, and 34% for recruiting research subjects.
To measure the impact of these adaptations, respondents who had engaged
in each of the above activities were asked to estimate the effect of the adaptation
on the amount of clinical research conducted in their department or institution.
Among those with a formalized process for assisting investigators to recruit
research subjects, more than half (53%) reported that this innovation had
a moderate to large effect on the amount of clinical research conducted. Similar
results were found for procedures that assist investigators by reviewing grants
prior to submission (47%) and revising a grant following a rejection (48%).
The innovations that were reported least likely to have a moderate to large
impact on the amount of research conducted were identifying research funding
(30%), identifying potential collaborators (40%), and writing grants (43%).
We surveyed the research leadership in US medical schools and found
substantial concern regarding the clinical research mission. Almost half (48%)
of all respondents did not consider their clinical research enterprise to
be healthy or robust. This finding is consistent with numerous reports citing
a broad-based concern regarding the present status of the clinical research
mission of AHCs.1- 3
A similar concern existed regarding the quality of clinical research.
Our respondents, especially SRAs, believe that considerable amounts of clinical
research do not meet their standards. One potential explanation for this finding
is that less than two thirds of SRAs had conducted clinical research and thus
may be less likely to consider such research as high quality. It may also
be that the expectations of respondents regarding clinical research are unrealistically
high given that clinical research as a discipline is younger than many of
the basic science disciplines or that our survey question regarding the research
quality may not adequately measure all aspects of the current research environment.
Regardless of the explanation, clinical research is seen by our respondents
as lower in quality than nonclinical research.
It is clear that several challenges to the clinical research mission
of AHCs exist. First, 9 out of 10 research leaders thought that pressures
to see patients and insufficient clinical revenues posed a moderate to large
problem for clinical research, and these perceptions were greatest among those
located in areas with high managed care penetration. These findings are consistent
with previous research, which showed that clinical researchers in the most
competitive markets have greater clinical care responsibilities5
and are less likely to receive internal support from their institution.6 These findings provide further evidence of the negative
impact of market pressures on the clinical research mission of AHCs. Second,
our respondents perceived an inadequate supply of trained clinical researchers.
Seventy-five percent of respondents reported a moderate to large problem recruiting
trained clinical researchers. Even among the most research-intensive institutions,
two thirds reported difficulties recruiting clinical researchers. This finding
may be the result of an underproduction of trained clinical researchers or
an inability of medical schools to assemble competitive compensation packages
sufficient to compete with nonacademic CROs or other job opportunities. Regardless
of the explanation, this study supports the widespread consensus that demand
for trained clinical researchers in academia may exceed the current supply.1,9,13
The data on strategic adaptations leaders have made provide insight
into potential management strategies to cope with these and other challenges.
Despite a clear sense of urgency, less than half of respondents said that
their department or institution had implemented various strategic policies
or mechanisms. Even among those with such strategies in place, confidence
in their impact was less than overwhelming. With the exception of helping
recruit research subjects (53%), in no case did a majority feel their strategies
had a moderate or large positive impact on the amount of clinical research
performed. In fact, the most frequently used mechanisms, such as helping investigators
identify funding sources, had the smallest positive impact on the amount of
research conducted while the least used (recruiting research subjects) had
the greatest impact.
However, concern regarding the clinical research enterprise may be tempered
by some of our findings. First, given that the high research-intensive institutions
receive approximately 80% of NIH funding,1
it is somewhat encouraging that almost three quarters of those institutions
rate the overall health and robustness of their clinical research enterprise
as good or excellent despite the challenges discussed above. Second, despite
greater pressures to see patients and insufficient clinical revenues, research
leaders in high managed care areas were more likely to rate the health and
robustness of their clinical research enterprise as good or excellent than
those in low managed care markets. The explanation for this finding is not
obvious. It is possible that other factors that occur in conjunction with
high managed care markets, such as the presence of life science companies,
provide resources that buttress the clinical research mission. Further studies
should address this issue.
Our study has several limitations. First, we do not know the extent
to which our respondents' perceptions adequately reflect reality. As a result,
these findings should be seen as suggestive of topics and research questions
that deserve future study. Second, our results are based on cross-sectional
data. Some of the effects we observed in the most competitive markets or in
the most research-intensive medical schools may be the result of adaptive
behaviors or lack thereof brought on by historical, internal, or external
stimuli instead of the static pressures occurring as a result of market competition
or large amounts of funding from the NIH. Third, we did not ask about all
the possible strategic adaptations that could be used by institutions. For
example, one strategy we did not explore is developing training programs to
better prepare clinical investigators with the tools for high-quality, patient-centered
research and to provide a greater supply of young clinical researchers. Fourth,
because of respondent confidentiality, we are unable to link individuals with
their institutions. As a result, it is possible that respondents' perceptions
of their research enterprise were affected by similar issues affecting their
institution at large.4
Nevertheless, this research provides the first systematic, national
data on how authoritative observers view the health of the clinical research
enterprise compared with nonclinical research, and the prevalence and effectiveness
of strategies to improve clinical research. As such, our study supports the
frequently voiced concerns about the problems of clinical research, suggests
that strategies that deal with these problems are underdeveloped, and that
capacity opportunities may exist.