Different Weights of the Evidence-Based Medicine Triad in Regulatory, Health Technology Assessment, and Clinical Decisio
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CURRENT OPINION
Different Weights of the Evidence-Based Medicine Triad in Regulatory, Health Technology Assessment, and Clinical Decision Making Evelyn Schlegl1 • Pierre Ducournau2 • Jo¨rg Ruof1,3,4
Published online: 11 July 2017 Ó The Author(s) 2017. This article is an open access publication
Abstract Evidence-based medicine (EBM) is defined as a systematic approach to clinical problem solving by the integration of best research evidence with real-world clinical expertise and patient values. Since those early days, decision requirements expanded from patient-centric clinical decision making to a population-based view including regulatory health technology assessments (HTAs). Regulatory bodies mainly rely on the totality of research evidence, which includes preclinical and all available clinical data. HTA bodies primarily focus on clinical data with a strong preference for comparative data from randomized controlled clinical trials (RCTs). Conversely, bedside clinical decisions are largely driven by real-world clinical expertise, which takes into account the individual patients’ preferences, as well as the availability of supportive research evidence. While the focus on research evidence is a typical feature of the early part of the adoption curve for innovative technologies, HTA decision makers need to ensure that clinical expertise is also appropriately included in their decisions, in order to avoid beneficial medications from being not available to patients.
& Jo¨rg Ruof [email protected] 1
HealthEcon Ltd, Steinentorstrasse 19, 4051 Basel, Switzerland
2
F. Hoffmann-La-Roche Ltd, Basel, Switzerland
3
Medical School of Hanover, Hanover, Germany
4
General Practitioner Office Hugenschmidt, Lo¨rrach, Germany
Key Points The evidence-based medicine (EBM) triad serves as the cornerstone of EBM; the well-established foundation for clinical, regulatory and health technology assessment (HTA) decision making. HTA and regulatory decisions are jeopardized by confusing EBM for research evidence alone, and neglecting the other two pillars of the triad: realworld experience and patient preferences. HTA decision making should take recommendations and the clinical expertise of respective scientific organizations into account, in order to avoid ‘false negative’ decisions on treatment benefit.
1 The Origin of the Evidence-Based Medicine (EBM) Triad In the early 1970s, Archie Cochrane described his fundamental clinical decision dilemma: ‘‘I had considerable clinical choice of therapy: my trouble was that I did not know which to use and when’’ [1]. Consequently, EBM and the respective triad was gradually established. As David Sackett, one of its founding fathers, has put it, EBM is: ‘‘a systematic approach to clinical problem solving by the integration of best research evidence with clinical expertise and patient values’’ [2]. Since those early days, decision requirements gradually expanded from patient-centric clinical decision making to a broader, population-based
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