Discussions about Comparative Effectiveness Research (CER) were not commonplace conversation just over a year ago, but as the Health Care Reform initiative has progressed, it seems that nearly every single day we hear something about CER. Just last week Medical Devices Today published a piece about the amount of NIH Comparative Effectiveness Research funding dollars committed solely to medical-device-focused CER in 2009, and the number was significant at $40 Million. While some of these monies were directed to the establishment of CER centers at different universities, the majority involved short-term (2 year) studies in CER with funding totals for each project approximately $500,000. These short-term projects were funded through the American Recovery and Reinvestment Act of 2009 as part of the economic stimulus package.
The clinical applications to be explored amid the medical device-focused CER studies range from cardiac imaging techniques to cancer screening modalities. Among this group, we were pleased to see research that compares uterine fibroid embolization (UFE) vs. magnetic resonance guided focused ultrasound for the treatment of uterine fibroids. This randomized clinical trial is being performed at the Mayo Clinic by long-time researcher of focused ultrasound for fibroids, Dr. Elizabeth Stewart. The results of this study should address some of the questions needed to better clarify where focused ultrasound compares in the spectrum of treatments for fibroids, yet is really the tip of the iceberg of the research needed in this disease. Historically, funding dollars for fibroid research have been extremely limited. Little research exists that looks comprehensively at the comparative effectiveness of even the most utilized surgical treatment options, let alone the comparison of those options to minimally or non-invasive alternatives desired by much of the patient population. We are hopeful that the Mayo study will have opportunities for continued funding beyond its $500,000. Additional funding could allow for greater representation of patient population (more sites involved in the trial and more patients assessed) and longer duration of follow-up (this study must be complete in a short 2-years, which doesn’t allow for sufficient follow-up to assess long-term outcomes).
We look forward to seeing additional research awards in this space – as the need is huge. For more on uterine fibroids and the impact of the disease, please check out the patient support organization Fibroid Relief.