CMTP Releases CER Summit Report
BALTIMORE, Maryland (September 13, 2011) The Center for Medical Technology Policy (CMTP) announces today the release of the “2010 National Leadership Summit on CER Priorities, Methods, and Policy: Building a Strategic Framework for Comparative Effectiveness Research in Oncology” Final Report.
Oncology was selected as the focus of the 2010 Inaugural CER Summit for compelling reasons. Cancer is a particularly challenging field for CER because new technologies are rapidly evolving, numerous new treatment regimens and targeted agents are available, and personalized medicine is becoming a reality. Because of this rapid change, there is an urgent and escalating need for evidence to guide treatment decisions and payment policies. The 2010 Summit therefore brought together national and global leaders in clinical trial design, comparative effectiveness research, and patient centered research to explore innovative methods, insights from the field, and policy ideas for advancing the development of comparative clinical research in oncology.Six principles emerged from discussions at the Summit and are discussed at length in the Final Report:
- CER studies in oncology are urgently needed. The human and economic costs of cancer to individuals and to society are immense, and while dramatic advances in treatment have been achieved, important gaps remain in our understanding of which treatments work and which benefit patients most.
- CER should fully engage patients and the general public. Patient involvement in clinical research design helps illuminate the questions that are most meaningful and relevant to treatment decisions. As such, patient advocacy groups represent a critical link to patients by providing education, encouraging enrollment in trials, providing guidance to researchers and helping to disseminate new clinical findings.
- CER requires the development of new research methods. Registry studies, pragmatic clinical trials and simpler variations of randomized trials offer alternatives that, when enhanced with innovative methodologies, can yield reasonably robust, clinically applicable results. However, the development of a national CER enterprise will require new evidentiary standards, new data sources, and improved methods for observational research.
- Genomics and personalized medicine must be central to all CER studies in oncology. Following the mantra of “getting the right care to the right patient at the right time,” personalized medicine aims to use genomic data to clearly understand which treatment(s) will optimize outcomes for the individual patient. Yet the role of CER in personalized medicine has yet to be clearly defined. This is particularly important in oncology, which more than any other field uses therapies based on differences in disease and treatment response predicted by molecular biomarkers.
- CER results must be translated into clinical practice. In evidence-based healthcare, findings from up-to-date, high-quality research inform clinical care, and improved methods with which to promote translation of CER into clinical practice will increase the ability of clinicians to implement these changes.
- The CER enterprise must address cost and value. While Congress limited consideration of cost and value in recent legislation, they will eventually demand attention. CER will ultimately need to incorporate nuanced metrics of patient value that include measures of patient experiences, out-of-pocket costs and other cost and value dimensions.
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CMTP is a private, non-profit organization which serves as a neutral forum to promote discussion and develop strategies that improve the quality of clinical research for healthcare decision making. CMTP is uniquely qualified to help develop the methods and strategies that will ensure that comparative effectiveness research fulfills its intended goal of helping patients, clinicians and payers make more informed healthcare decision.
