NPC Sponsors Health Affairs Briefing: Current Challenges In Comparative Effectiveness Research
NPC sponsored a cluster of articles in the October 2012 issue of Health Affairs, “Current Challenges in Comparative Effectiveness Research,” and a related briefing on October 11, to raise awareness of the uneven playing field in the health communications landscape, including industry’s challenge to correct the spread of erroneous or misleading information and supply the quality research that stakeholders are seeking.
Overview
Health Affairs Briefing on Comparative Effectiveness Research: Welcome & Remarks
Health Affairs Editor-in-Chief Susan Dentzer and NPC President Dan Leonard kicked off the briefing, which had more than 170 participants in attendance. In his opening remarks, Mr. Leonard addressed some of the limitations facing health care stakeholders, particularly the pharmaceutical industry, in their ability to communicate research results to decision makers.
The panel discussions that followed reacted to a hypothetical case study of comparative effectiveness research (CER) involving a fictional migraine drug. Questions raised included how those research findings could be disseminated and communicated by various health care stakeholders, how patient involvement in the study could have improved the usefulness of the results, and whether there are barriers to the uptake of CER in clinical practice.
Legal Issues On Promotion And Communication Of Comparative Effectiveness Research
The first panel at the Health Affairs briefing featured Dr. Aaron Kesselheim, assistant professor of medicine at the Harvard School of Public Health, Dr. Eleanor Perfetto, senior director of evidence-based strategies at Pfizer Inc, and Dr. Tevi Troy, senior fellow at the Hudson Institute. Dr. Kesselheim explained that because there are not yet adequate procedures in place to evaluate the validity of observational studies, the Food and Drug Administration's (FDA) reluctance to "authorize promotional claims" based on these studies is "understandable." But clarity about how to dispute or discuss these studies is needed, especially if the data is flawed or promoted by non-industry groups, said Dr. Perfetto. She suggested that stakeholders convene to develop voluntary best practice principles for communicating and disseminating comparative effectiveness research.
Patients’ Concerns And Patient Centeredness
Marc Boutin, EVP & COO, National Health Council, explained that because most patients do not understand what comparative effectiveness research (CER) is, it can be challenging to educate them about available treatment options. He suggested ways for patients to be engaged throughout the research continuum, along with the development of usability criteria, which would enable CER end-users to determine whether the information could be useful in making treatment decisions.
Dr. Rachael Fleurence, Scientist, Patient-Centered Outcomes Research Institute (PCORI), described the factors PCORI is taking into account when it considers funding a comparative effectiveness research study. PCORI's criteria, she said, is focused on the impact the research will have on patient outcomes and the use of rigorous methodology. In addition, PCORI is seeking stakeholder input via workshops and a "suggest a research question" on its website.
Dr. Art Caplan, director of the Division of Medical Ethics at NYU Langone Medical Center, participated via telephone and agreed that it can be challenging to provide vetted information in a form that is useful to patients.
The Use Of Research By Payers And Clinicians
Dr. Robert Dubois, Chief Science Officer, National Pharmaceutical Council, described the issue of "asymmetry" in the comparative effectiveness research communications landscape, including the pharmaceutical industry’s challenge to correct the spread of erroneous or misleading information and supply the quality research that stakeholders are seeking. He outlined two key issues: first, the type of research used by the Food and Drug Administration (FDA) to make drug approval and labeling decisions is more stringent than the information that can be used by other health care decision makers. Second, FDA regulates the type of research that can be discussed by industry in most forums, but not by other stakeholders. He also suggested that all health care stakeholders communicating CER information should adhere to voluntary best practices.
Dr. Michael Fischer, Associate Professor of Medicine, Harvard Medical School, and Associate Physician, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, defined academic detailing and how it is used. In particular, he outlined some of the challenges in determining how to take comparative effectiveness research studies and communicate the findings to clinicians. He said the choice of topics to cover in academic detailing is driven by the needs of the population, and the goal is to close information gaps by providing clinicians with needed evidence and how it could be used in practice.
Moving Comparative Effectiveness Research Forward
During the final panel discussion, Dr. Harold Sox, editor emeritus of the Annals of Internal Medicine, and Dr. Justin Timbie, associate policy researchers at RAND, looked at future challenges facing the Patient-Centered Outcomes Research Institute (PCORI) and comparative effectiveness research (CER). Specifically, Dr. Timbie said that there are several reasons why CER fails to change patient care and clinical practice, and understanding those challenges could impact PCORI's research and communications efforts for the better. But Dr. Sox cautioned that for PCORI to succeed before its funding expires in 2019, it must start with a research project agenda that conveys a sense of urgency and strategic direction.
To view or download the presentations, please visit the Health Affairs website.