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Medical Rehabilitation: Guidelines to Advance the Field With High-Impact Clinical Trials

Published:August 24, 2018DOI:https://doi.org/10.1016/j.apmr.2018.08.173

      Abstract

      The purpose of this Special Communication is to summarize guidelines and recommendations stemming from an expert panel convened by the National Institutes of Health, National Center for Medical Rehabilitation Research (NCMRR) for a workshop entitled The Future of Medical Rehabilitation Clinical Trials, held September 29-30, 2016, at the NCMRR offices in Bethesda, Maryland. The ultimate goal of both the workshop and this summary is to offer guidance on clinical trials design and operations to the medical rehabilitation research community, with the intent of maximizing the effect of future trials.

      Keywords

      List of abbreviations:

      AE (adverse event), DSMB (data and safety monitoring board), CRC (clinical research coordinator), CRF (case report form), GCP (good clinical practice), ICH (International Council on Harmonization), IRB (institutional review board), MOP (manual of procedures), NCMRR (National Center for Medical Rehabilitation Research), PCT (pragmatic clinical trial), PI (principal investigator), PRECIS (Pragmatic-Explanatory Continuum Indicator Summary), REACT (Rehabilitation Research Resource to Enhance Clinical Trials), RCT (randomized controlled trial), SCI (spinal cord injury), SCT (social cognitive theory), SMART (sequential, multiple assignment, randomized trial)
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