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Communicating About Comparative Effectiveness Research: A Health Affairs Symposium on the Issues

Abstract (from Health Affairs): The United States is pursuing an agenda of increased comparative effectiveness research in an effort to identify high-value health care. One of many issues connected with the research is how findings will be communicated, particularly if they pertain to prescription drugs and if the findings could be useful for promotional purposes yet fall short of the standard of "substantial evidence” required by the Food and Drug Administration (FDA) under federal law. To surface and air the relevant issues, one article in this issue of Health Affairs posits a hypothetical case study of comparative effectiveness research involving a fictional migraine drug. A symposium of analyses and responses to this study follows from various stakeholders representing the FDA; the Patient-Centered Outcomes Research Institute, and pharmaceutical companies; an attorney for the industry; academic specialists in the area of pharmaceutical law and policy; a proponent of academic detailing, or university or non-commercial-based education of prescribers based on medical evidence; a payer; a bioethicist; and an official from an organization representing patients with chronic diseases and disabilities.

The National Pharmaceutical Council (NPC) provided funding for this issue and contributed to the article, "Communication About Results of Comparative Effectiveness Studies: A Pharmaceutical Industry View." 

This issue follows up on related topics raised during a conference hosted by NPC, the National Health Council and WellPoint in February 2012. NPC Chief Science Officer Dr. Robert Dubois explains the concerns about CER communications in the brief video that follows.


Blog Post

CER Tweets of the Week (April 7-11, 2014)

Collaboration was a popular topic among comparative effectiveness research (CER) stakeholders on Twitter this week. They tweeted about the National...
YouTube Videos

Webinar: CER Collaborative: Tools You Can Use

Collaborative members hosted a webinar explaining how to use the tools they developed to create greater uniformity and transparency when evaluating...
Blog Post

CER Tweets of the Week (March 31- April 4, 2014)

This week, health care stakeholders on Twitter highlighted the many activities and sessions at the Academy of Managed Care Pharmacy’s (AMCP) 26th...
Blog Post

4/8 Webinar on CER Collaborative: Tools You Can Use

The CER Collaborative--a group formed by the Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes...
Press Release

CER Collaborative Improving Health Outcomes Through New Comparative Evidence Tools

(Washington, DC, March 24, 2014)—Three peer-reviewed articles published in Value in Health offer important guidance to aid formulary decision-makers...
Press Release

NPC, Quintiles Study Tests Tools to Evaluate Quality of Observational Research in Comparative Effectiveness Studies

(Washington, DC, February 25, 2014)—With the growing demand for information about comparative effectiveness and questions about the quality of...
Press Release

NPC, UMD Study: Factors That Cause Different Treatment Responses Are Not Well Understood or Studied

Washington, DC, November 4, 2013—Although researchers and health care providers widely recognize that individuals with stage IV prostate cancer react...
Press Release

National Pharmaceutical Council Statement on Appointment of PCORI Board Chair

Washington, DC, September 19, 2013—The National Pharmaceutical Council (NPC) today released the following statement regarding the Government...
Commentary and Testimony Page

The State of CER and the Environment for Health Care Decision Making

This month, NPC released its third annual survey on stakeholders’ views on comparative effectiveness research (CER), “The State of Comparative...
Commentary and Testimony Page

Keeping Our Eye on the CER Ball

Until the cherry blossoms begin to bloom later next month, most of the water cooler conversations in Washington will focus on the federal budget....
Commentary and Testimony Page

Leveling the Playing Field? Could a Landmark Decision Alter the CER Communications Landscape?

A growing chorus of voices is publicly sharing data on the effectiveness of treatment options, but one viewpoint has long been shut out of key areas...
Commentary and Testimony Page

Living Up to Its Name? The Role of Patient-Centered Research

Anyone who has ever received bad news from his or her health care provider or held a loved one’s hand when a diagnosis was delivered can understand...
YouTube Videos

Webinar: CER Collaborative: Tools You Can Use

Collaborative members hosted a webinar explaining how to use the tools they developed to create greater uniformity and transparency when evaluating...
YouTube Videos

Leveraging Real-World Data and Analytics in the Device Industry

Thomas Abbott, PhD, head, health care informatics at Johnson & Johnson, Medical Devices and Diagnostics, talks about the impact of big data and...
YouTube Videos

IMEDS: Sentinel and OMOP Programs

Jane Reese-Coulbourne, MS, ChE, executive director of the Reagan-Udall Foundation, talks about the Food and Drug Administration's Sentinel Initiative...
YouTube Videos

Big Data: Its Evolving Use and Challenges

William Crown, PhD, chief scientific officer at Optum Labs, discusses how the use and nature of big data in health care has been evolving in recent...
Blog Post

CER Tweets of the Week (April 7-11, 2014)

Collaboration was a popular topic among comparative effectiveness research (CER) stakeholders on Twitter this week. They tweeted about the National...
Blog Post

CER Tweets of the Week (March 31- April 4, 2014)

This week, health care stakeholders on Twitter highlighted the many activities and sessions at the Academy of Managed Care Pharmacy’s (AMCP) 26th...
Blog Post

4/8 Webinar on CER Collaborative: Tools You Can Use

The CER Collaborative--a group formed by the Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes...
Blog Post

CER Collaborative Rolls Out New Resources to Aid Formulary Decision-Making

A newly published series of peer-reviewed articles developed by the CER Collaborative will help formulary decision-makers more effectively evaluate...

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