Sean R Tunis
Affiliation: Food and Drug Administration
- Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policySean R Tunis
Office of Clinical Standards and Quality, Centers for Medicare and Medicaid Services, Baltimore, MD 21244, USA
JAMA 290:1624-32. 2003..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...
- Access with evidence development: the US experiencePenny E Mohr
Center for Medical Technology Policy, Baltimore, Maryland 21202, USA
Pharmacoeconomics 28:153-62. 2010....
- Using health technology assessment to identify gaps in evidence and inform study design for comparative effectiveness researchSean R Tunis
Center for Medical Technology Policy, World Trade Center Baltimore, Baltimore, MD 21202, USA
J Clin Oncol 30:4256-61. 2012..Recent efforts are beginning to demonstrate the potential to build on the work invested in developing HTA reports to provide a roadmap toward these objectives...
- Comparative effectiveness research: Policy context, methods development and research infrastructureSean R Tunis
Center for Medical Technology Policy, World Trade Center Baltimore, 401 E Pratt St, Suite 631, Baltimore, MD 21201, USA
Stat Med 29:1963-76. 2010..The approach to addressing each of these issues should be informed by the understanding that the primary purpose of CER is to help health care decision makers make informed clinical and health policy decisions...
- A clinical research strategy to support shared decision makingSean R Tunis
Centers for Medicare and Medicaid Services CMS, Baltimore, Maryland, USA
Health Aff (Millwood) 24:180-4. 2005..A more systematic effort to produce this evidence will entail establishing research priorities, improving research methods, expanding the research infrastructure, and engaging new funds...
- Medicare coverage of ICDsMark B McClellan
Center for Medicare and Medicaid Services, Baltimore, USA
N Engl J Med 352:222-4. 2005
- Economic analysis in healthcare decisionsSean R Tunis
Am J Manag Care 10:301-4. 2004
- Why Medicare has not established criteria for coverage decisionsSean R Tunis
N Engl J Med 350:2196-8. 2004
- Coverage options for promising technologies: Medicare's 'coverage with evidence development'Sean R Tunis
Center for Medical Technology Policy
Health Aff (Millwood) 25:1218-30. 2006....
- The National Oncologic PET Registry: expanded medicare coverage for PET under coverage with evidence developmentMatthew J Lindsay
Foley Hoag, LLP, 155 Seaport Blvd, Boston, MA 02210 2600, USA
AJR Am J Roentgenol 188:1109-13. 2007..By linking access to PET for virtually all Medicare beneficiaries to the collection of clinically valuable evidence, the NOPR represents the cutting edge of the CED approach...
- Coverage with evidence development: a very good beginning, but much to be done. Commentary to Hutton et alSean R Tunis
Centre for Medical Technology Policy, 524 2nd Street, San Francisco, California 94107, USA
Int J Technol Assess Health Care 23:432-5. 2007
- Federal initiatives to support rapid learning about new technologiesSean R Tunis
Center for Medical Technology Policy, San Francisco, CA, USA
Health Aff (Millwood) 26:w140-9. 2007..The value of these efforts will depend on coordination among individuals and institutions in the public and private sectors; clarity about focus, purpose, and priorities; and adequate and reliable long-term funding...