Over the past many months there have been countless journal articles, news reports, and blog postings in the US on the topic of comparative effectiveness research or "CER," a type of research that compares available medications and other treatments in order to help doctors and patients make decisions about which treatment is most appropriate for an individual patient. Comparative effectiveness has gotten a boost from the Affordable Care Act, which provided federal funding for CER to the Patient-Centered Outcomes Research Institute (PCORI) and the Agency for Healthcare Research and Quality (AHRQ). In addition, individuals and groups from all types of healthcare backgrounds--clinicians, patients, health policy researchers and payers--have laid out justifications for CER and how such research should be conducted, analyzed, communicated, and used.
At GSK, we are focused on determining how to properly design, and apply, CER in the real world. Many of our colleagues are working to understand how to develop and deliver medicines and vaccines to meet many unmet medical needs and to help providers ensure that these medicines and vaccines will be used for the right patient at the right time. Recognizing the importance of CER to answering questions about who should receive a specific medication or treatment, we are also working to ensure CER is conducted in a robust manner with appropriate rigor, transparency, and strong methodologies.
However, we also believe that research alone is not sufficient--we know that research findings must be replicable, clearly communicated, properly contextualized, and broadly disseminated.
We are excited by a new series of articles this week in Health Affairs that focus on the communication of CER findings, who should be able to share study results, and how best to share this information--including the role that pharmaceutical companies should play .
While everyone realizes that CER has an important role in improving the effectiveness and efficiency of our healthcare system, pharmaceutical companies, despite their extensive expertise in their products, face significant challenges in speaking about CER studies.
In Health Affairs, a group of authors from the National Pharmaceutical Council, including Jack Bailey, SVP, Policy, Payers and Vaccines, GSK, discuss how Food and Drug Administration (FDA) regulations and policies may limit how pharmaceutical companies communicate information about CER findings and may even hinder companies' efforts to respond to CER studies involving their products. The authors call for FDA to provide clear guidance that allows companies to participate meaningfully in discussions about CER studies.
CER is anything but simple, but whether it is questions about the design, communications or more topics to come, we look forward to being a part of the conversation.