Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.

ABSTRACT:

Importance

Facilitating the development of safe and effective medications for schizophrenia is a public health imperative.

Objectives

To evaluate the association of shortening randomized clinical trial (RCT) duration with the modification of the Positive and Negative Syndrome Scale (PANSS) for the design of RCTs of medications for schizophrenia and to offer perspective on an alternative regulatory pathway to the historically accepted trial duration and response assessment.

Data sources

A database was created consisting of clinical trial data from 32 placebo-controlled RCTs of 8 atypical antipsychotic drugs approved by the US Food and Drug Administration (FDA) between January 1, 2001, and December 31, 2015. The database included information on total and individual PANS

SUBMITTER: Younis IR 

PROVIDER: S-EPMC7330825 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature