Recognizing that Evidence is Made, not Born

Robyn Lim, David K. Lee, Pierre Sabourin, John Ferguson, Marilyn Metcalf, Meredith Smith, Solange Corriol-Rohou, 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

Research output: Contribution to journalArticlepeer-review

2 Scopus citations


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.

Original languageEnglish
Pages (from-to)844-856
Number of pages13
JournalClinical Pharmacology and Therapeutics
Issue number4
StatePublished - 1 Apr 2019
Externally publishedYes


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