Kim McCleary on PDUFA

A paradigm shift is occurring. Patients were once viewed as passive, deferential recipients of medical products and services developed for them. Today, there is growing recognition that patients are a vital force for transformative change to address serious unmet medical needs and improve public health. To deliver on the promise of a patient-focused biomedical system, stakeholders across the research and care enterprise are working – mostly independently – to define and scale effective patient engagement, develop instruments to measure patient-reported outcomes, quantify preferences, and incorporate patient perspectives and insights into decision-making processes and work flows. A science of patient input is emerging, borrowing methods from health economics, marketing, social science, and epidemiology. In these early days though, there is little documented evidence of successful practices or failed experiments to inform programs, guide resource allocations, or shape policy. Maturing the nascent stage of patient input can be accelerated by the three Cs outlined below. Collaboration: More collaboration will help establish and expand best practices, standardize methods, and demonstrate the value proposition for engaging with patients in continuous, reciprocal relationships. FasterCures’ Benefit-Risk Advisory Council, comprised of key opinion leaders from patient, academic, industry, and trade organizations, provides one forum for such collaboration. In September, Council m...
Source: PHRMA - Category: Pharmaceuticals Authors: Source Type: news