Comparative Effectiveness Research Toolkit

Authors: National Pharmaceutical Council 

Publication: June 2010 (updated March 2011)

The establishment of the nonprofit, public-private entity, the Patient-Centered Outcomes Research Institute (PCORI), in the new health reform law has elevated the visibility and importance of comparative effectiveness research (CER) in the health care system. But as CER takes on an increasingly influential role in informing coverage decisions and the treatments that patients receive, many questions remain about how to ensure that the comparative evidence that is developed is both scientifically valid and communicated in such a way that it can be applied appropriately.

To help you and your colleagues understand CER and some of the important questions under discussion, the National Pharmaceutical Council has developed this Comparative Effectiveness Research Tool Kit.

This CER Tool Kit includes the following materials (see links below for PDFs):

• The Patient-Centered Outcomes Research Institute: Methodology Committee Resource Guide, with biographical information about the PCORI methodology committee members and background information on the different types of CER;
• The Patient-Centered Outcomes Research Institute Resource Guide, which includes biographical sketches of the PCORI board of governors, a history of CER and the law that created PCORI, and additional resouces;
• Demystifying Comparative Effectiveness Research: A Case Study Learning Guide (full report, executive summary, and key points document), which provides guidance to help stakeholders understand the three primary types of CER and includes a checklist on how to evaluate a CER study and assess its applicability to a particular health care decision;
• Framing the Debate/Untangling the Potential Impact of Comparative Effectiveness Research on Innovation (full report and key points document), which explores how CER investments will shape incentives for bringing new therapies to market; 
• National Institute for Health and Clinical Excellence (NICE): How Does It Work and What Are the Implications for the U.S.? (executive summary), which examines the U.K.’s health technology assessment organization and discusses key learnings from this organization; and
• The Good ReseArch for Comparative Effectiveness (GRACE) principles, which address good practice for the design, conduct, analysis, and reporting of observational studies of comparative effectiveness.

Additional copies of the materials can be ordered through NPC’s website or by contacting Gail Durrer at gdurrer@npcnow.org or 703-620-6390.

NPC Research:

• The Patient-Centered Outcomes Research Institute: Methodology Committee Resource Guide (2011)
• Patient-Centered Outcomes Research Institute Resource Guide (2010)
• Demystifying Comparative Effectiveness Research: A Case Study Learning Guide (2009)
• Demystifying Comparative Effectiveness Research: A Case Study Learning Guide (Executive Summary) 2009
• Framing the Debate/Untangling the Potential Impact of Comaprative Effectiveness Research on Innovation
• National Institute for Health and Clinical Excellence (NICE): How Does it Work and What Are the Implications for the U.S.? (2008)
• The Good ReseArch for Comparative Effectiveness (GRACE) principles

Other CER Materials:

• NPC’s Comparative Effectiveness Informational Series, July 2010 (complete articles/PDF)

Individual articles (much of this information is available in the PCORI Resource Guide):

• Defining Evidence-Based Medicine and Comparative Effectiveness Research
• A Brief History of Comparative Effectiveness Research and Evidence-Based Medicine
• NPC’s Key Considerations on Comparative Effectiveness Research
• Comparative Effectiveness Research Provisions in the Patient Protection and Affordable Care Act
• Comparison of Various Comparative Effectiveness Research Legislative Activities in the Context of NPC’s CER Recommendations to the Institute of Medicine, Federal Coordinating Council on CER and the Agency for Healthcare Research and Quality (PDF)
• Additional Resources