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ISSN: 1935-1232 (P)

ISSN: 1941-2010 (E)

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Abstract

Use of Standard Methodology for Novel Outcomes in Clinical Trials: Advantages for New Therapeutics in Neurosciences
Author(s): Silvia Zaragoza Domingo*, Amy Pinkham, Daniella Tinoco, Jan Kottner, Pavel Balabanov and Florence Butlen-Ducuing

This invited commentary provides a summary of recently published recommendations on outcomes selection when designing clinical trials for new therapeutics in psychiatry and neurology. The authors, a recently convened independent and interdisciplinary group of experts, highlight the relevance of harmonizing research practices, either by private or public researchers, in order to increase the likelihood of successfully identifying effective and safe treatments in psychiatric or neurologic conditions. This represents the first attempt to provide guidance to the field that aims to improve the efficiency of clinical research and the likelihood of demonstrating efficacy and safety for new compounds.