Looking for Guidance? FDA and PFDD at “Patients as Partners” 2019

Looking for Guidance? FDA and PFDD at "Patients as Partners" 2019 By Hannah Eccard Pujita Vaidya, Senior Advisor, Patient Focused Drug Development (PFDD) program at the Center for Drug Development and Research (CDER) at the FDA, told an audience at the Patients as Partners Conference last week that patients are the experts on their conditions and on day-to-day life with their disease. A patient outcome—where improvement with treatment is meaningful in daily life—can only be understood in a patient’s own words. Vaidya noted that, “patients ‘chief complaints’ may not be factored explicitly into drug development plans.” 1 [...]

Patient and caregiver perceptions of clinical trials: Preliminary findings

Patient and caregiver perceptions of clinical trials: Preliminary findings By Kathleen Hoffman, PhD, MSPH Many of you have been in Philadelphia for the “Patients as Partners Conference.” Yesterday, Hannah Eccard, Research manager at Inspire, participated in a panel discussion titled, “Mapping Out the Patient Decision Journey.” The panel discussed the link between understanding patients --their lives, lifestyle, experiences-- and trial protocol design. Recently, Inspire’s research team completed the preliminary analysis of a survey to understand patient and caregiver perceptions and attitudes toward clinical trials. Over 1500 (1644), patient and caregiver members  experiencing either ovarian, prostate or colorectal [...]