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Sean R Tunis

Publications and source records attributed to Sean R Tunis.

6 recordsLinked to original sources
PubMed2003

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

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.

Clinical Trials as Topic↗
PubMedDate not supplied

A clinical research strategy to support shared decision making.

Greater use of evidence in health care decision making has highlighted the limited quantity and quality of evidence for many decisions. To make informed decisions, patients and physicians depend on valid evidence about benefits, risks, and costs of alternative treatments. Policymakers can also use this information to make promising new technologies available sooner, while ensuring adequate evaluation. The clinical research enterprise can be expanded with simple trials and registries. A more systematic effort to produce this evidence will entail establishing research priorities, improving research methods, expanding the research infrastructure, and engaging new funds.

Decision Making, Organizational↗
PubMedDate not supplied

Coverage options for promising technologies: Medicare's 'coverage with evidence development'.

In April 2005 the Centers for Medicare and Medicaid Services (CMS) posted on its Web site a draft guidance document describing a new approach to coverage policy called "coverage with evidence development" (CED). CED offered an option for coverage of promising drugs, biologics, devices, diagnostics, and procedures that would not otherwise meet Medicare's evidentiary standards for being "reasonable and necessary." An updated guidance was posted 12 July 2006, clarifying several key statutory, regulatory, and operational issues. This paper traces the history of this policy approach, explains the rationale behind the policy, and describes the major challenges that will need to be addressed for CED to become an important advance in evidence-based coverage decision making.

Biomedical Technology↗