Recognizing that Evidence is Made, not Born

• DOI: 10.1002/cpt.1317
• Publication Date: 2018-11-25T11:06:10Z
• Authors: Robyn Lim; David K. Lee; Pierre Sabourin; John Ferguson; Marilyn Metcalf; Meredith Smith; Solange Corriol‐R...; Hans‐Georg Eichler; Murray Lumpkin; Gigi Hirsch; Inhua Muijrers Chen; Brian O'Rourke; Anja Schiel; Nick Crabb; Naomi Aronson; Edmund Pezalla; Marc Boutin; Louise Binder; Linda Wilhelm
• Keywords: Reimbursement; Evidence-Based Practice

Therapeutic product development, licensing and reimbursement may seem a well-oiled machine, but continuing high attrition rates, regulatory refusals, patients' access issues suggest otherwise; despite serious efforts, gaps persist between stakeholders' stated evidence requirements actual supplied. Evidentiary deficiencies and/or human tendencies resulting in avoidable inefficiencies might be further reduced with fresh institutional cultures/mindsets, combined context-adaptable practices framework that integrates emerging innovations. Here, Structured Evidence Planning, Production, Evaluation (SEPPE) posits treated as something produced, much like other manufactured goods, for which "built-in quality" (i.e., "people" "process") approaches have been successfully implemented globally. Incorporating proactive, iterative feedback-and-adjust loops involving key decision-makers at critical points could curtail quality decision hazards-pulling needed therapeutic products of beneficial performance through to approvals. Critical success, however, is dedicated, long-term commitment systemic transformation.