We all are familiar with the traditional government funding agencies that sponsor research, including the National Institutes of Health, the U.S. Department of Defense, and the many and varied private foundations, such as the Susan G. Komen Breast Cancer Foundation, but few of us are familiar with the new Patient-Centered Outcomes Research Institute (PCORI). Two authors of this column—Dr. Chang and Dr. Greenberg of the Cancer Care Delivery Research Committee of the Alliance/American College of Surgeons Clinical Research Program (ACS CRP)—were recently awarded PCORI grants. This column is intended to inform Bulletin readers of this new institute, the research it will support, and the projects that are getting under way.
PCORI is an independent, not-for-profit research funding institution authorized by Congress as part of the Affordable Care Act of 2010. It is funded through a trust that receives monies from the U.S. Treasury and fees assessed on private and public health plans. PCORI is charged with funding clinical comparative effectiveness research (CER) to provide information on best evidence that will help patients and their providers make better informed decisions about their care, including cancer care. The CER priorities of PCORI are distinguished from prior initiatives such as the American Recovery and Reinvestment Act of 2009 by an emphasis on stakeholder engagement to help researchers design research questions and measure outcomes that are most relevant to them. More information regarding PCORI is available at www.pcori.org.
Alliance/ACS CRP awards approved
PCORI approved two awards sponsored by the Alliance/ACS CRP to fund CER aimed at answering questions most important to patients and their caregivers. The newly approved awards will fund studies on posttreatment surveillance:
- Posttreatment Surveillance in Breast Cancer: Bringing CER to the Alliance (Dr. Greenberg)
- Patient-Centered, Risk-Stratified Surveillance after Curative Resection of Colorectal Cancer (Dr. Chang)
Dr. Greenberg’s study seeks to develop a new approach to surveillance following breast cancer treatment that will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors. The project has three primary goals: (1) use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics; (2) use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer; and (3) engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide posttreatment care, as well as identify the highest-priority strategies for prospective randomized trials.
Dr. Chang’s study will address a critical question that patients often raise: “Based on my individual tumor characteristics, conditions, and preferences, what is the best way to monitor me?” By tailoring the strategy for monitoring to the individual colorectal cancer survivors—taking into account their risk for recurrence, eligibility for salvage treatment, and personal preferences—the study seeks to improve the cancer care experience for patients and identify strategies to improve the effectiveness of cancer monitoring and reduce the burden on patients and the health care system.
These studies represent an important new approach to research—one in which patients and providers together identify the most pressing research questions. As part of previous work with the Agency for Healthcare Research and Quality’s Developing Evidence to Inform Decisions about Effectiveness Cancer Consortium, stakeholders were engaged to identify the highest priority topic for CER in cancer care. Posttreatment surveillance was identified for a variety of reasons, including the number of patients and practitioners facing this decision every day, the uncertainty about the optimal approach, and the applicability across cancer sites. By designing parallel studies in colon and breast cancer, we hope to take a more efficient approach to research by sharing resources and experience.
Furthermore, a major challenge exists in translating knowledge generated by research into clinical practice. By addressing the cancer care delivery research question that is the most relevant to patients and their providers and refining the study design based on stakeholder input we hope to improve the relevance of both the research question and the study outcomes to maximize the potential for incorporation into daily practice. The major goal of these projects is to improve the effectiveness of posttreatment surveillance in real-world practice, and the Alliance/ACS CRP provides the ideal setting to conduct this work.
Both observational studies will use data from the National Cancer Data Base as well as legacy data from Alliance clinical trials and other databases and will engage cancer survivors, health care providers, and researchers to guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. The knowledge gained through these studies will provide important new tools to guide patients and their clinicians in making individualized decisions regarding cancer surveillance.
The studies are two of 71 projects totaling more than $114 million approved for funding in PCORI’s latest round of awards. All were selected through a highly competitive review process in which scientists, patients, caregivers, and other stakeholders helped to evaluate more than 570 proposals that responded to five PCORI funding announcements.
Proposals were evaluated on the basis of scientific merit, how well they engage patients and other stakeholders, their methodological rigor, and how well they fit within PCORI’s national research priorities. All awards were approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
Over the next few years, we can anticipate a continued increase in the support and focus on health services research, including patient-centered outcomes, comparative effectiveness, and cancer care delivery research. The Cancer Care Delivery Research Committee of the ACS CRP aims to develop a program to support investigators in their pursuit of studies in this important area. These two initial PCORI projects will play an important role in launching this initiative.