by Susan Trinidad, MA, Research Scientist in the Department of Bioethics & Humanities at the Center for Genomics & Healthcare Equality at the University of Washington

I sure hope somebody is reading this, since I am inside (near a power outlet) instead of enjoying the sunshine during our afternoon break! In this post, I’ll be sharing some of the highlights from didactic workshop A4, Comparative Effectiveness Research: What Bioethicists Need to Know.

This was an all-star panel: Walter Straus, MD, MPH, PRIM&R Board Member, and global director of scientific affairs for Merck’s vaccines division; Hugh Tilson, MD, DrPH, another Board member with faculty appointments at a minimum of two universities (and I think there were more!); Steven Teutsch, MD, MPH, chief science officer of the Los Angeles County Department of Public Health and co-editor of a new book, Public Health Practice: What Works; and Newell McElwee, PharmD, MSPH, executive director of outcomes research at Merck & Co.

Dr. Strauss provided a brief orientation to comparative effectiveness research (CER), which has become a hot topic since its inclusion in the Affordable Care Act and the establishment of the Patient-Centered Outcome Research Institute (PCORI). CER is aimed at closing the substantial knowledge gap in understanding what works and doesn’t work in health care, with the goal of enhancing patients’ decision-making in the clinical setting. As Dr. Strauss pointed out, with $1 billion set aside to fund CER over the next seven years, there’s going to be more of this on our radar. But these studies will likely look quite different from randomized control trials by design—and what will that mean for institutional review boards?

Dr. Tilson planted the key questions, where does CER fit in the grand scheme of similar activities?; how is it like (and unlike) quality improvement, public health surveillance, and other observational studies? and; at what point, and in what way, might ethics review or other human research protections program (HRPP) oversight come into play for CER? He unveiled a hot-off-the-presses copy of the “boundaries report,” Health-Related Activities along the Boundary between Research and Practice: When to Take Alternate Approaches to Providing Ethical Oversight, a new white paper produced as part of PRIM&R’s Boundaries Project, that addresses some of these questions.

Next up was Dr. Teutsch to explain what CER is, some of the history that led to its development, what its goals are, and some of the open questions about where it might take us over the next few years. He traced the development of CER in relation to other turning points, including John Wennberg’s work on geographic practice variation, the move toward evidence-based medicine, and Centers for Medicare and Medicaid Services (CMS) policies supporting coverage with evidence development. He also proposed an important distinction between evidence synthesis and evidence-based decision making, which you can read about here.

Dr. McElwee shared his insights about how CER and PCORI came to prominence, noting that the “patient-centered” emphasis may have been a calculated choice on the part of Congressional lawmakers who wanted to address health care quality, but knew that an industry-focused approach wouldn’t fly. Key milestones in the process were a 2006 paper by Gail Wilensky, former head of CMS, that laid out a blueprint for effectiveness research; a New England Journal of Medicine article by Peter Orszag, then with the Congressional Budget Office, which asserted that current healthcare costs were unsustainable; and the Institute of Medicine Report, Knowing What Works in Health Care.