Health Affairs examines how we talk about research
In a special issue released today, Health Affairs examines the “Current Challenges in Comparative Effectiveness Research” and how the findings from this kind of research may – or may not – be promoted and used by pharmaceutical companies, payers, providers and others involved in health care decision-making.
Comparative effectiveness research evidence is generated from research studies that compare drugs, medical devices, tests, surgeries, or ways to deliver health care. It is designed to inform health-care decisions by looking at existing evidence and generating new evidence.
The call for evidence-based medicine is not new, but the topic has generated more attention in recent years with increased funding for comparative effectiveness research through the stimulus act and health care law. One-billion dollars in funding has been given to Federal agencies to scale up their efforts on comparative effectiveness research.
With funding for CER in place, some of the questions now being asked are: how can CER be done appropriately and how can communication of these findings be done in a way that is fair?
AstraZeneca supports research that helps inform physician-patient decisions and healthcare that works. Through our work in real-world evidence, we look beyond the information needed for FDA approval. We look to analyze how medicines and treatments already on the market are working in a number of disease areas and improving quality and managing total cost of care.
Unlike randomized controlled clinical trials used for regulatory filings, most real-world evidence studies use observational, naturalistic, and other types of non randomized clinical trial data such as electronic medical records, claims information and patient surveys. By examining data associated with the delivery of care, real-world analyses can assess treatment impact on health outcomes important to patients.
But, as Health Affairs points out, there are limitations to what the pharmaceutical industry is allowed to say regarding its research while other stakeholders have considerably less regulation over their communications. This asymmetry in communications could ultimately hurt patients because providers and other decision makers do not have all of the available information.
While randomized, controlled clinical trials are the regulatory standard by which safety and efficacy of drugs are demonstrated in the United States, these studies often are designed with numerous controls that may limit the ability to answer questions related to the real-world delivery of healthcare. Studying the use of a drug, device or other treatment in a real-world setting can yield insights into costs, optimum co-therapies, and medical best practices that the focus of clinical trials cannot.
Today’s release of the October issue of Health Affairs is accompanied by a symposium with a variety of health care stakeholders. This issue and forum was supported by the National Pharmaceutical Council.