Status of clinical research in academic health centers - Views from the research leadership

Context The changing state of the health care system in the United States m ay be adversely affecting clinical research conducted in academic health ce nters (AHCs). Few formal data have been gathered about the nature and exten t of the problems facing clinical research or the effects of remedies under taken by AHCs. Objectives To assess the perceived quality and health of the clinical resea rch enterprise and to determine challenges and adaptations to current envir onmental pressures. 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 resp ondents, 478 completed a questionnaire, yielding an overall response rate o f 67.1% (64.8% for SRAs and 67.8% for department chairs). Main Outcome Measures Ratings of overall health/robustness of clinical rese arch, 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 o f the clinical research enterprise as good or excellent compared with 63% f or nonclinical research (P<.001). Respondents were most likely to rate nonc linical research as high in quality (79%) compared with 70% for phase 3 cli nical 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 percei ved as a moderate-to-large problem for clinical research by the largest per centage of respondents (93%), followed by insufficient clinical revenues (8 9%), recruiting trained researchers (75%), lack of external support for cli nical 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 consider ed the challenges facing clinical research in AHCs to be urgent or extremel y urgent. Conclusions Academic leaders perceive clinical research activities in AHCs to be less healthy, of poorer quality, and facing greater challenges than n onclinical research activities. Many AHCs do not have policies or mechanism s to address challenges facing the clinical research mission. Even among th ose with such policies, more than half do not believe these policies have h ad large positive effects. Our findings support the view that the clinical research workforce and infrastructure may need to be expanded and strengthe ned to keep pace with advances in basic research.