Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.

By S. Tunis, D. Stryer, C. Clancy. Journal of the American Medical Association (JAMA), 2003

1,783 citations recorded by the source corpus.

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, and funding.

Subfields: Economics and Econometrics, General Health Professions

View Paper: https://www.semanticscholar.org/paper/1351da07afd721a5ad61d0810941cfdbfc85520a

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Citations in the corpus

How can we increase translation of research into practice? Types of evidence needed. (2007, methodology): “We encourage more practical trials (28, 36, 100) that address the context and external validity issues in Table 2 and hypothesize that increased funding, conduct, and transparent reporting (33, 49) of such trials will greatly enhance translation.”
Using electronic health records to drive discovery in disease genomics (2011, background): “All the complexity of polypharmacy and environmental influences that are present in clinical practice are not necessarily considered in studies designed to detect genetic associations or in clinical trial”
Evaluating the Relevance, Generalization, and Applicability of Research (2006, background): “To remedy these mismatches of evidence and the needs and circumstances that prevail in the " real world, " Tunis et al. (2003) recommend conducting " practical trials " that have the characteristics in Table 1.”
A pragmatic–explanatory continuum indicator summary (PRECIS): a tool to help trial designers (2009, neutral): “Pragmatic randomized trials that seek to answer the question, ‘‘Does this intervention work under usual conditions?’’ [5,6] address these 10 domains in different ways when there are important differences between usual and ideal conditions.”
Best Care at Lower Cost: The Path to Continuously Learning Health Care in America (2013, background): “The current research knowledge base provides limited support for answering important types of clinical questions, including those related to comparative effectiveness and longterm patient outcomes (British Medical Journal, 2011; Gill et al., 1996; IOM, 1985; Lee et al., 2005a; Tunis et al., 2003).”
External validity: We need to do more (2006, background): “Current quality rating approaches do not address the needs of decision makers ( 12 ), with the exception of one or two general items on target population.”
Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research (2015, background): “An extension of the concept of ''practical clinical trials'' (Tunis et al. 2003), effectiveness-implementation hybrid designs provide benefits such as more rapid translational gains in clinical intervention uptake, more effective implementation strategies, and more useful information for…”
Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial. (2004, background): “The results of pragmatic clinical trials have been heralded as the foundation for changing practice guidelines and clinical care.(21) The design of the SYNERGY trial, with broad inclusion of high-risk patients in geographically diverse areas and across different clinical practice settings, along wit”
Effect of bright light and melatonin on cognitive and noncognitive function in elderly residents of group care facilities: a randomized controlled trial. (2008, neutral): “Light 23 (12) 23 (13) 22 (17) 28 (22) 26 (11) 27 (31) Melatonin 18 (7) 27 (26) 30 ( 23 ) 23 (15) 32 (36) 33 (33)”