Using Quantitative and Qualitative Research to Enhance Patient Focused Drug Development

Using Quantitative and Qualitative Research to Enhance Patient Focused Drug Development By Hannah Eccard FDA’s focus of incorporating the patient voice into the drug development process requires the life science industry to engage in new research strategies. Based on what we're seeing so far from the FDA, it appears that the agency is closely considering the value of mixed methods: qualitative research along with quantitative research. Dr. Theresa Mullin, Associate Director for Strategic Initiatives at the Center for Drug Evaluation and Research (CDER) at FDA, said at the first guidance meeting for Patient Focused Drug Development (PFDD) [...]

Social Listening to Understand the Unmet Needs of Patients

Social Listening to Understand the Unmet Needs of Patients By Marina Shayevich and Sara Ray Across healthcare, patients lament the imperfection of pharmaceutical treatment. Although grateful to have life saving and life improving medications, patients are often met with frustration at the limitations of their medications. Nowhere is that more evident than in rare diseases, where the rarity of the illness may lead to a scarcity of available, approved pharmaceutical treatment options. Many patients are left to turn to off-label medication use in the effort to get the best solution possible. Even then, these treatments do not [...]