Contributed by: Mary Beth Ritchey, PhD, Principal Epidemiologist for Medical Devices, RTI Health Solutions
"Regulators and reimbursement authorities want to utilize real world data more consistently to capture the real-world patient and clinician experience."
The visibility of real world evidence (RWE) is increasing and this is exciting for those of us in the field of healthcare research. We see it in the media, hear it discussed at industry conferences, and observe it being requested more often from patients, clinicians, pharmaceutical and medical device companies, regulators, and legislative bodies. The US Congress has mandated that the FDA consider how RWE should be leveraged for regulatory decision making.
Pharmacoepidemiologists, health outcomes researchers, and health economists have been generating RWE for decades. We are seeing the landscape changing as a result of increasing stakeholder engagement. In the past, research questions were answered with "one-off" studies, and the evidence generated from these studies was compiled into dossiers or distributed to clinicians upon request. Today, insurance claims databases and electronic medical records are being populated at every healthcare encounter and people are actively monitoring their everyday activities through devices such as fitness watches and smartphone apps to maintain good health.
Increasingly, regulators and reimbursement authorities want to utilize these rich sources of data more consistently to capture the real-world patient and clinician experience. Stakeholders want to use this real-world data (RWD) to better understand the state of health in individuals and in the population. Furthermore, when data are captured close to real-time, we have the potential to target patients most likely to benefit from treatment.
With more visibility, acceptance, and optimism for the use of RWE, it is paramount that we maintain rigorous research methods to address important questions about drugs, devices, and biologics that are available to the public. Some RWD are high quality and can be used to investigate many research questions. Others have more limited utility and are better suited for hypothesis generation or exploratory analysis. As we look toward the increased use of RWD, finding the right data to address each research question is of utmost importance.
We conduct best-practice research by starting with strategy. First, we consider the appropriate research questions to provide evidence for the proposed indications and value message. Then we then identify the best data to address the research questions, including combining multiple sources or generating new sources of data when needed. Moreover, an expert research team must analyze the data using the most appropriate methodology and report results in an easy to interpret and transparent method.
It is encouraging to see the amount of discussion surrounding RWE research. The opportunity to engage in the conversation is plentiful. I look forward to listening and joining in on the discussion.
Learn more about our approach to real world evidence.