A more multidisciplinary and team-based approach in research and clinical settings. More use of registries and EMRs. More trends showing healthier patients. And, above all others, more of a push to find value and cost savings in a changing reimbursement environment. Those are the take-home messages for the cardiovascular community from leaders in research, practice, government and business as they share their perspectives on 2012's challenges and opportunities.
Trials and tribulation
The prospects of cardiovascular research in 2012 lend to both excitement and concern, according to Anthony N. DeMaria, MD, editor-in-chief of the Journal of the American College of Cardiology, and director of the cardiology center at the University of California, San Diego School of Medicine. Closer collaborations among cardiologists and other specialties, for instance, may be opening the door for insightful studies; cardiovascular registries now are in place to inform both research and practice; and follow-up studies from recent landmark randomized controlled clinical trials are poised to answer critical questions about cost-effectiveness.
Simultaneously, concerns about the shift of innovative research from the U.S. to overseas possibly may grow from chatter to a crescendo in 2012.
"There is going to be a continuing and perhaps increasing focus on the difference in trial results between various geographic locations," DeMaria predicts. "Are the results that you obtain in one area of the world with one set of patients with their own genetic and socioeconomic conditions applicable to patients in another part of the world with slightly different genetic and socioeconomic conditions?"
In an analysis of National Heart, Lung and Blood Institute (NHLBI)-supported cardiovascular randomized controlled clinical trials, Kim et al found that 19 of the 24 studies included international participants (J Am Coll Cardiol 2011;58:671-676). International participants made up nearly half the enrollment in the 11 coronary artery disease trials in the analysis.
"Why is it that devices, therapies and procedures that initially were invented in the U.S. go outside the U.S. for their clinical evaluations?" DeMaria asks. He is not alone in his questioning. The NHLBI launched its Clinical Research United in Successful Enrollment initiative in 2010 followed by a workshop to examine barriers that have led to the outsourcing of clinical trials.
Workshop attendees identified the high costs of recruiting and retaining study participants as one deterrent; in October, the co-chair of the workshop published recommended strategies to help regain prominence in the U.S., including budgeting tools and reimbursement agreements for covering the costs of investigational items (JAMA 2011;300:1798-1799).
In the meantime, DeMaria anticipates that large randomized trials that compared novel anticoagulants to warfarin may release cost-effectiveness data as soon as 2012. Those trials include ARISTOTLE, which found that the Xa inhibitor apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent and death by 11 percent (N Engl J Med 2011;365:981-92). The ARISTOTLE paper came on the heels of the ROCKET-AF trial, which showed promising results for the factor Xa inhibitor rivaroxaban (Xarelto, Bayer Healthcare). But at what price? "That is critically important, particularly because warfarin is a relatively inexpensive drug compared with these other agents," DeMaria says.
DeMaria sees registries such as the American College of Cardiology's (ACC) PINNACLE (Practice Innovation and Clinical Excellence) playing a key role in research in 2012. The cardiovascular outpatient database includes more than two million records of U.S. patients and includes a network of thousands of cardiology practices. "There is a lot of information that will come from registries that will help inform practice, but more than that, it will point out issues that need to be improved," he says.
Registries like PINNACLE will be especially critical for identifying cost-saving opportunities, as anticipated federal reimbursement cuts nip into expenditures. "It seems to be clear that we won't be able to keep spending, so the question is, what are we doing that isn't of great value? These registries are going to point to the answer," DeMaria says.
Expect more multidisciplinary partnering in research institutions