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 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 by AHCs.
OBJECTIVES: To assess the perceived quality and health of the clinical research enterprise and to determine challenges and adaptations to current environmental 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 respondents, 478 completed a questionnaire, yielding an overall response rate of 67.1% (64.8% for SRAs and 67.8% for department chairs). 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.