Within3 senior director of product commercialization and training Meerim Almazbek writes in Clinical Research News about how patient-centered strategies transform clinical trials.
One of the driving forces behind this shift is the recently updated Patient-Focused Drug Development Guidelines from the FDA. “There are both ethical and business incentives to adopt patient-centered strategies throughout the drug development process,” says Almazbek. But that’s not all. The FDA’s recent Patient-Focused Drug Development (PFDD) guidelines have made patient centricity a matter of regulatory necessity.”
While the guidelines draw attention to patient-centric issues, life science teams should also note the benefits of a patient-focused approach. “By including the voice of the patient in protocol design, clinical teams can help minimize barriers to participation—improving trial recruitment rates—and enhancing the patient experience,” writes Almazbek. “Together, these factors help reduce dropout rates. More participants completing a trial equates to more drugs potentially achieving FDA approval, and ultimately, making it to market.”
So how can trial teams implement the new guidance without interrupting important ongoing work? Almazbek says she’s seen first-hand how asynchronous virtual engagement and insights management technology enable decentralized trials. “Other technologies—such as artificial intelligence, network analytics, and natural language processing—are helping clinical teams better understand disease communities.”
Get more insight in the full article to learn about the benefits of a patient-focused approach.
