Monday Musings

9-7-15The drug industry, patients and consumers are urging the FDA to find better ways to integrate the patient perspective in drug development, as well as a way to use “real world” data in drug development. It will be interesting to see how the FDA reacts to the growing emphasis on patient-focused activities since the RCT has been the standard for so long. How will they accommodate “the patients’ voice”?

Avalere Health, a strategic advisory firm, released a report in January which listed the need for “patient engagement” as one of the priorities for the FDA. The FDA Safety and Innovation Act required FDA to further incorporate patient perspectives into the drug development and review processes, known as the Patient-Focused Drug Development (PFDD) initiative.

There are a lot of benefits to utilizing real-world and post-market evidence data that are particularly relevant to wound care. Real world data is the best way to investigate safety as well as effectiveness. Frankly, asking the patient if they have healed may be that the most logical way to determine whether a wound has healed. There are many other aspects of wound care (devices, biologicals and prescriptives) that could strongly benefit from real world data. Thanks to stage 2 certified EHRs, we can obtain it. That’s what the USWR is doing.