Sean Tunis

Thursday, May 17

09:00 – 09:45


Developing a Methodological Framework to Improve the Quality and Relevance of Research in Integrative Medicine

Sean Tunis, MD, MSc

Founder and Director, Center for Medical Technology Policy

Former CMO, Centers for Medicare and Medicaid Services



Presentation Overview

Major gaps in knowledge are consistently identified in virtually all systematic reviews and clinical guidelines in both conventional and integrative medicine, whether the topic of review is drug therapy for dementia, radiation therapy for prostate cancer, surgical therapy for rotator cuff injuries, or acupuncture for back pain.  As patients or clinicians, we are generally faced with making difficult decisions about different interventions with limited evidence to inform those decisions.  Furthermore, a number of treatment options that may well be helpful are not widely available or covered by insurance because their benefits and risks have not been adequately evaluated. Most studies in traditional, complementary and integrative medicine were designed to detect specific effects of these interventions and are not very useful for clinical decision-making in a usual care setting.  An important contributor to the evidence gaps for clinical decision-making is the historical lack of engagement of decision makers in developing research priorities, refining research questions, and crafting study protocols.  Comparative effectiveness research and patient-centered outcomes research are relatively recent attempts to meaningfully engage decision makers in the process of evidence development.    The core premise of this approach to research is, for example, to learn from patients what outcomes are most relevant to them, from clinicians which comparators are the most common options they consider, and asking payers what patient characteristics would be most helpful to reflect in the study inclusion and exclusion criteria.  These insights are then reflected in how clinical studies are designed.  Rapid improvements in the quality and consistency of evidence may be achieved by collaborative efforts between clinicians, patients and researches to develop consensus on the optimal approaches to conducting research for specific categories of health interventions.   Work of this kind in now underway in the field of integrative medicine (acupuncture and traditional Chinese medicine) and a number of other clinical domains.



Sean Tunis, MD, MSc. is the Founder and Director of the Center for Medical Technology Policy in Baltimore, Maryland.  CMTP’s main objective is to improve the quality, relevance and efficiency of clinical research by providing a neutral forum for collaboration among experts, stakeholders and decision makers.   Dr. Tunis was a member of the Institute of Medicine Committee on Initial National Priorities for Comparative Effectiveness Research.   He advises a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, evidence based medicine, clinical research, reimbursement and health technology policy.

Through September of 2005, Dr. Tunis was the Chief Medical Officer at the Centers for Medicare and Medicaid Services (CMS), where he had lead responsibility for clinical policy for the Medicare and Medicaid programs.  Previously, he served as the Director of the Health Program at the Congressional Office of Technology Assessment and as a health policy advisor to the U.S. Senate, where he worked on pharmaceutical and device policy issues. 

Dr. Tunis trained at the University of California in Los Angeles and the University of Maryland in Internal Medicine and Emergency Medicine, and holds adjunct faculty positions at the Center for Health Policy at Stanford University, the Department of Internal Medicine at the Johns Hopkins School of Medicine, and the Department of Surgery at the University of California at San Francisco.