Leading Researchers Outline Principles for Conduct of Comparative Effectiveness Research

New study offers guidelines to ensure consistency in comparative effectiveness research

WASHINGTON, Sept. 11, 2012 /PRNewswire-USNewswire/ -- A new set of principles developed by a group of leading researchers could help to ensure more consistency in how comparative effectiveness research (CER) is planned and conducted. These guiding principles were published today in the September issue of The Journal of Comparative Effectiveness Research.

The principles and paper were developed by Bryan R. Luce, Ph.D., MBA, United BioSource Corporation and the University of Washington; Michael F. Drummond, Ph.D., University of York; Robert W. Dubois, MD, Ph.D., National Pharmaceutical Council; Peter J. Neumann, ScD, Tufts Medical Center and Tufts University School of Medicine; Bengt Jonsson, Ph.D., Stockholm School of Economics (Sweden); Uwe Siebert, MD, MPH, MSc, ScD, University of Health Sciences, Medical Informatics and Technology (Austria) and Harvard School of Public Health; and J. Sanford Schwartz, MD, Wharton School of Business and Perelman School of Medicine, University of Pennsylvania.

"These are voluntary principles that can help to improve the quality of CER, which in turn can help patients and providers make better treatment decisions," said Dr. Luce. "For CER to succeed in guiding health decisions, it should be planned and conducted with rigor and transparency."

To arrive at these best research practice principles, the researchers examined existing health technology assessment principles and engaged multiple CER experts and stakeholders for feedback.

The resulting 13 principles include ensuring that the research objectives are clear, being transparent in how the research is conducted, involving stakeholders, including especially relevant decision makers, in a meaningful way throughout the research process, considering perspectives and interests from a wide range of stakeholders, using relevant comparators, and evaluating relevant outcomes and the impact of individual treatment effects on patients. The researchers acknowledge that "no one study will necessarily be able to fully meet every principle to the letter," but that CER should always endeavor to fulfill, and never ignore, their intent.

"Going forward, it will be important to evaluate how well CER studies adhere to these principles. We can then determine whether CER studies that use those principles are having an impact on patient care or are being appropriately adopted into guidelines and clinical practice," said Dr. Dubois.

About the National Pharmaceutical Council
The National Pharmaceutical Council is a health policy research organization dedicated to the advancement of good evidence and science, and to fostering an environment in the United States that supports medical innovation. Founded in 1953 and supported by the nation's major research-based pharmaceutical companies, NPC focuses on research development, information dissemination, and education on the critical issues of evidence, innovation and the value of medicines for patients. For more information, visit www.npcnow.org and follow NPC on Twitter @npcnow.

About the Journal of Comparative Effectiveness Research
The editorial direction of Journal of Comparative Effectiveness Research (www.futuremedicine.com/loi/cer) is the responsibility of Senior Editors, Prof. Sheldon Greenfield (University of California, Irvine) and Dr. Eugene Rich (Mathematica Policy Research, Washington, DC). The Senior Editors are supported by a team of six Associate Editors, together with an Advisory Panel of 40 international experts. London-based publishers Future Medicine are part of the Future Science group and are specialists in providing healthcare practitioners and research professionals with high-quality evaluated information. For more details, including free trials to the journal, or to contribute, please contact the Launch Editor Laura Dormer ([email protected]).

SOURCE National Pharmaceutical Council