Recognizing that Evidence is Made, not Born

Autor: Nick Crabb, Gigi Hirsch, Robyn Lim, Pierre Sabourin, Naomi Aronson, Linda Wilhelm, Murray Lumpkin, David K Lee, Louise Binder, Brian O'Rourke, Hans-Georg Eichler, Marilyn Metcalf, Anja Schiel, Inhua Muijrers Chen, Solange Corriol-Rohou, John Ferguson, Meredith Smith, Marc Boutin, E Pezalla
Rok vydání: 2019
Předmět:
Zdroj: Clinical Pharmacology and Therapeutics
ISSN: 1532-6535
0009-9236
Popis: Therapeutic product development, licensing and reimbursement may seem a well‐oiled machine, but continuing high attrition rates, regulatory refusals, and patients’ access issues suggest otherwise; despite serious efforts, gaps persist between stakeholders’ stated evidence requirements and actual evidence supplied. Evidentiary deficiencies and/or human tendencies resulting in avoidable inefficiencies might be further reduced with fresh institutional cultures/mindsets, combined with a context‐adaptable practices framework that integrates emerging innovations. Here, Structured Evidence Planning, Production, and Evaluation (SEPPE) posits that evidence be treated as something produced, much like other manufactured goods, for which “built‐in quality” (i.e., “people” and “process”) approaches have been successfully implemented globally. Incorporating proactive, iterative feedback‐and‐adjust loops involving key decision‐makers at critical points could curtail avoidable evidence quality and decision hazards—pulling needed therapeutic products with high quality evidence of beneficial performance through to approvals. Critical for success, however, is dedicated, long‐term commitment to systemic transformation.
Databáze: OpenAIRE
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