NPC in Key Leadership Role in CER Discussions at the 15th Annual International ISPOR Meeting
May 15-19, 2010
The National Pharmaceutical Council's Vice President for Clinical and Scientific Affairs, Dr. Les Paul, spoke to large audiences about the evaluation, dissemination and interpretation of comparative effectiveness research (CER) at the International Society for Pharmacoeconomics and Outcomes Research's (ISPOR) 15th Annual International Meeting. Approximately 2,000 health outcomes researchers, physicians, pharmacists, scientists, and others attended the meeting, which was held May 15-19 in Atlanta, GA.
During the course of the meeting, Dr. Paul was a panel speaker in two symposia and a workshop that all focused on CER. At the first symposium, sponsored by IMS Health, "Will Comparative Effectiveness Research Survive Health Reform?", Dr. Paul took a closer look at the timeline and issues involved with the implementation of the new public-private CER entity, the Patient-Centered Outcomes Research Institute (PCORI). He pointed out that operational details, such as the structure and setup of the board of governors and committees, the scientific standards and research methods that will be followed, the role of AHRQ’s Offices of Communications and Knowledge Transfer, and the guidance for the use of CER, among other issues, must still be addressed.
During this discussion, Dr. Paul was joined by Penny Mohr, MA, Vice President of Programs at the Center for Medical Technology Policy; Daniel A. Ollendorf, MPH, ARM, Chief Review Officer at the Institute for Clinical and Economic Review; and moderator Vernon Schabert, PhD, Principal for Health Economics and Outcomes Research at IMS Health.
Research sponsored by NPC and conducted by Cerner LifeSciences, "Demystifying Comparative Effectiveness Research: A Case Study Learning Guide," served as the basis for a workshop, "Your Role in Interpreting and Appropriately Communicating CER Results in a Highly Charged Environment." Dr. Paul participated in this workshop, which took a closer look at how to evaluate CER results through three consecutive steps: 1) Consider for whom the findings are applicable; 2) Consider whether any aspects of the study design might affect the results; and 3) Consider whether the findings may change with new research. In particular, Dr. Paul focused on what constitutes “good” evidence and how it could be interpreted and disseminated.
In addition to Dr. Paul, Jean Slutsky, Director of the Center for Outcomes and Evidence at the Agency for Healthcare Research and Quality, and Brian Sweet, RPh, Chief Pharmacy Officer at WellPoint, Inc., took part in this discussion that was moderated by Dr. Robert DuBois, Chief Medical Officer at Cerner LifeSciences.
Copies of the NPC-sponsored report were distributed widely at the meeting.
Finally, Dr. Paul delivered remarks during a discussion, "Comparative Effectiveness and Standards of Evidence: The Intersection of Science, Policy, Regulation and Business," sponsored by United BioSource Corporation. During this discussion, Dr. Paul delved into the importance of “harmonizing” high-quality CER standards to create a more predictable environment for adoption and diffusion of CER results in order to inform health care decisions and improve health outcomes. Speakers included Dr. Paul; Brian Sweet of WellPoint, Inc.; Laurie Burke, RPh, Director of Study Endpoint and Label Development at the FDA's Center for Drug Evaluation and Research; and Dr. Bryan Luce, Senior Vice President of United BioSource Corporation, who moderated the discussion.
View Dr. Paul's slide presentations: