Development and Application of the Placebo Response Model in Clinical Trials for Primary Sjogren's Syndrome.

ABSTRACT: This study aimed to develop a placebo response model for pharmaceutical clinical trials of primary Sjogren's syndrome,and to quantitatively analyze the distribution and related factors influencing the placebo response to further optimize the design of clinical trials and evaluate the results of single-arm clinical trials. Public databases, including PubMed, Embase, and Cochrane Library were searched for reports on randomized placebo-controlled trials for Sjögren's syndrome which used the change from baseline in ESSDAI score as the primary outcome. The model-based meta-analysis method was used to evaluate the time course and the related influencing factors of the placebo response for ESSDAI in such clinical trials. A virtual placebo control group was constructed based on the final placebo r

SUBMITTER: Wang ZZ 

PROVIDER: S-EPMC8635096 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature