Promising Treatments on the Horizon and the Barriers of Moving
from Clinical Trials to Clinical Practice
Target Audience: Clinicians & researchers addressing acute or chronic pain
As a result of participating in this activity, learners will be better able to:
Understand and be able to contribute to the biomedical research translation continuum
“The gap between what we know and what we do in public health is lethal to Americans, if not the world.” - David Satcher, MD, PhD, Former U.S. Surgeon General
Only 25% of highly promising biomedical discoveries result in a published randomized clinical trial, and less than 10% are established in clinical practice within 20 years. In 2001, the Institute of Medicine (IOM) identified the importance and difficulty of translating basic science knowledge to patient care. In 2003, the National Institutes of Health (NIH) Roadmap identified translational research as a critical component of health care improvement.
In 2016, the 21st Century Cures Act made changes to the FDA Drug Approval process, and in 2018 the FDA announced plans to overhaul the 510(k) device approval process.
Accelerated approval pathways and the acceptance of new standards of evidence create opportunities for new therapies, but require prudence from researchers and regulators.
Drolet, B. C., & Lorenzi, N. M. (2011). Translational research: understanding the continuum from bench to bedside. Translational Research, 157(1), 1-5.
MD, PhD, FIPP,
Professor of Anesthesiology,
Cleveland Clinic, Learner Research Institute & Case Western Reserve University
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