Everything is local: a framework for clinical global assessment in drug development
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1CIRCA-PHD LLC (present), 7702 Maryknoll Ave. Bethesda, MD 20817, USA; Venture Mentor, Beth Israel Deaconess Medical Center, Technology Ventures Office, Boston, MA, USA.
Abstract:
The Clinical Global Impression (CGI) Scale was developed as an efficient means to capture drug effect in the burgeoning field of psychopharmacology during the 1960s and 1970s. It has also served as an anchor for scaling symptom scale results and as a regulatory endpoint. For reasons largely related to its lack of definition, disease-specific versions have been developed. The overlap between these CGIs and symptom scales raises a question as to the utility of a global scale. Future direction in this issue could be directed by increased use of the Activity of Daily Living or Functionality Scales to describe clinical meaningfulness.
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