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Recognizing that Evidence is Made, not Born
Author(s) -
Lim Robyn,
Lee David K.,
Sabourin Pierre,
Ferguson John,
Metcalf Marilyn,
Smith Meredith,
CorriolRohou Solange,
Eichler HansGeorg,
Lumpkin Murray,
Hirsch Gigi,
Chen Inhua Muijrers,
O'Rourke Brian,
Schiel Anja,
Crabb Nick,
Aronson Naomi,
Pezalla Edmund,
Boutin Marc,
Binder Louise,
Wilhelm Linda
Publication year - 2019
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.1317
Subject(s) - reimbursement , context (archaeology) , quality (philosophy) , business , risk analysis (engineering) , product (mathematics) , process (computing) , process management , evidence based practice , operations management , marketing , medicine , economics , computer science , health care , economic growth , mathematics , alternative medicine , epistemology , pathology , biology , operating system , paleontology , philosophy , geometry
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.