Stevan W. Gibson, president and CEO of the Lupus Foundation of America wrote a guest column for the Clinical Leader on "How An Advocacy Group Elevates The Patient Voice In Research And Clinical Trials."
He wrote, "Over the last few years, we have seen stakeholders across the healthcare community increasingly work to meaningfully incorporate the patient perspective into drug development. Patient engagement is only valuable if it’s meaningful; for us that means looking to a leader in this area, the National Health Council (NHC). The NHC defines patient engagement as 'Direct relationships and partnerships that are bidirectional, reciprocal, and continuous. Communications are open, honest, and clear. Engagement goals, participants, methods, desired impacts, and actual impacts are clearly outlined and transparent.'
In recent years, we’ve seen the federal government get more involved in creating initiatives to elevate the patient voice. In 2012, the FDA launched its patient-focused drug development (PFDD) initiative. The PFDD initiative is grounded in a simple belief: that the people living with a condition are experts and must be involved in the development of therapies. The FDA called for PFDD meetings to more systematically gather patients’ perspectives on their condition and therapies available to them. As the Lupus Foundation of America knows well, people living with lupus are the experts and have a unique understanding of the disease and what outcomes are most important in developing a treatment. Nonprofit organizations like ours, the biopharmaceutical industry, and other stakeholders are embracing this effort to elevate the patient voice."