Author Affiliations: Centers for Medicare & Medicaid Services, Baltimore, Md (Dr Tunis); and Agency for Healthcare Research and Quality, Rockville, Md (Drs Stryer and Clancy).
Decision makers in health care are increasingly interested in using
high-quality scientific evidence to support clinical and health policy choices;
however, the quality of available scientific evidence is often found to be
inadequate. Reliable evidence is essential to improve health care quality
and to support efficient use of limited resources. The widespread gaps in
evidence-based knowledge suggest that systematic flaws exist in the production
of scientific evidence, in part because there is no consistent effort to conduct
clinical trials designed to meet the needs of decision makers. Clinical trials
for which the hypothesis and study design are developed specifically to answer
the questions faced by decision makers are called pragmatic or practical clinical
trials (PCTs). The characteristic features of PCTs are that they (1) select
clinically relevant alternative interventions to compare, (2) include a diverse
population of study participants, (3) recruit participants from heterogeneous
practice settings, and (4) collect data on a broad range of health outcomes.
The supply of PCTs is limited primarily because the major funders of clinical
research, the National Institutes of Health and the medical products industry,
do not focus on supporting such trials. Increasing the supply of PCTs will
depend on the development of a mechanism to establish priorities for these
studies, significant expansion of an infrastructure to conduct clinical research
within the health care delivery system, more reliance on high-quality evidence
by health care decision makers, and a substantial increase in public and private
funding for these studies. For these changes to occur, clinical and health
policy decision makers will need to become more involved in all aspects of
clinical research, including priority setting, infrastructure development,
Tunis SR, Stryer DB, Clancy CM. Practical Clinical Trials: Increasing the Value of Clinical Research for Decision Making in
Clinical and Health Policy. JAMA. 2003;290(12):1624–1632. doi:10.1001/jama.290.12.1624
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