Participant enrollment is essential to the success or failure of a clinical trial. Without adequate enrollment, a trial may be too small to derive conclusive data. From a diversity perspective, the lack of diverse patient pools limit abilities to identify differences in gender, ethnicity, environmental, or socioeconomic factors contributing to disease, as well as responses to treatment.

The costs associated with clinical trial enrollment are steep. A 2011 report by Cutting Edge Information found that per-patient clinical trial costs rose an average of 70 percent across all development phases since 2008. In particular Phase IIIa and Phase IIIb saw an average 88 percent and 86 percent rise, respectively, with per-patient costs topping $40,000. Participant recruitment was the biggest factor associated with the cost increases.

In an effort to help address the need for strong clinical trial participation, reduce the burden for both practices and patients, and potentially drive down costs associated with recruitment, the ACC has developed the PINNACLE Registry^® Research Alliance. The PINNACLE Registry currently captures 25,000 detailed physician-patient encounters each day. The Alliance provides opportunities to leverage these clinical encounters to help facilitate patient identification, screening and recruitment. Patients identified through PINNACLE can then be shared with their personal physician to facilitate a constructive shared-decision-making encounter around possible trial participation. The inaugural program being supported by the Alliance is the ODYSSEY Outcomes Clinical Trial Program being co-developed by Sanofi and Regeneron Pharmaceuticals, Inc., which is focused on enhancing research with alirocumab, an investigational monoclonal antibody target PCSK9 (proprotein convertase subtilisin/kexin type 9). Since PCSK9 is known to elevate circulating low-density lipoprotein cholesterol levels, inhibiting the PCSK9 pathway is a potentially novel way to reduce LDL-C.

In addition to trial recruitment, Alliance participation can help patients access therapies not easily available outside of cardiovascular trials; provide participants with cutting-edge research results to improve practice and patient care; and provide access to clinical data and superior informatics for cutting-edge research opportunities.

“Cardiovascular medicine is changing and we are confident that the PINNACLE Registry Research Alliance is at the leading edge of the technical innovation that will improve quality patient care,” says ACC President John Gordon Harold, MD, MACC. “PINNACLE already represents a significant proportion of American cardiovascular care, linking a geographically diverse cohort of practices with a unified, comprehensive data system. This robust interconnectivity will facilitate our ability to understand potential research cohorts faster, cheaper, and more precisely than ever before, all while reducing the data collection burden.”

PINNACLE Registry practices are encouraged to join the Alliance to take advantage of opportunities to participate in a variety of research opportunities and clinical trials. To learn more, visit NCDR.com/PinnacleAlliance.

Keywords: Lipoproteins, LDL, Proprotein Convertases, Cholesterol, Registries, Patient Care, Physician-Patient Relations, Subtilisin, Cost of Illness, United States, Cardiology Magazine, ACC Publications

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