scholarly journals Placebo Response in Pediatric Anxiety Disorders: Implications for Clinical Trial Design and Interpretation

2016 ◽  
Vol 26 (8) ◽  
pp. 686-693 ◽  
Author(s):  
Eric T. Dobson ◽  
Jeffrey R. Strawn
Keyword(s):  
Clinical Trial ◽  
Anxiety Disorders ◽  
Trial Design ◽  
Placebo Response ◽  
Clinical Trial Design ◽  
Pediatric Anxiety ◽  
Pediatric Anxiety Disorders

scholarly journals Placebo Response in Pediatric Anxiety Disorders: Results from the Child/Adolescent Anxiety Multimodal Study

2017 ◽  
Vol 27 (6) ◽  
pp. 501-508 ◽  
Author(s):  
Jeffrey R. Strawn ◽  
Eric T. Dobson ◽  
Jeffrey A. Mills ◽  
Gary J. Cornwall ◽  
Dara Sakolsky ◽  
...  
Keyword(s):  
Anxiety Disorders ◽  
Placebo Response ◽  
Adolescent Anxiety ◽  
Pediatric Anxiety ◽  
Pediatric Anxiety Disorders

scholarly journals A longitudinal model for the Mayo Clinical Score and its sub-components in patients with ulcerative colitis

2021 ◽  
Author(s):  
Sonoko Kawakatsu ◽  
Rui Zhu ◽  
Wenhui Zhang ◽  
Meina T. Tang ◽  
Tong Lu ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Trial Design ◽  
Placebo Response ◽  
Clinical Trial Design ◽  
Clinical Score ◽  
Prior Exposure ◽  
Tnf Α ◽  
Over Time

AbstractClinical trials in patients with ulcerative colitis (UC) face the challenge of high and variable placebo response rates. The Mayo Clinical Score (MCS) is used widely as the primary endpoint in clinical trials to describe the clinical status of patients with UC. The MCS is comprised of four subscores, each scored 0, 1, 2 and 3: rectal bleeding (RB), stool frequency (SF), physician’s global assessment (PGA), and endoscopy (ENDO) subscore. Excluding the PGA subscore gives the modified MCS. Quantitative insight on the placebo response, and its impact on the components of the MCS over time, can better inform clinical trial design and interpretation. Longitudinal modeling of the MCS, and the modified MCS, can be challenging due to complex clinical trial design, population heterogeneity, and limited assessments for the ENDO subscore. The current study pooled patient-level placebo/standard of care (SoC) arm data from five clinical trials in the TransCelerate database to develop a longitudinal placebo response model that describes the MCS over time in patients with UC. MCS subscores were modeled using proportional odds models, and the removal of patients from the placebo/SoC arm, or “dropout”, was modeled using logistic regression models. The subscore and dropout models were linked to allow for the prediction of the MCS and the modified MCS. Stepwise covariate modeling identified prior exposure to TNF-α antagonists as a statistically significant predictor on the RB + SF subscore. Patients with prior exposure to TNF-α antagonists had higher post-baseline RB + SF subscores than naive patients.

scholarly journals Error‐related brain activity in pediatric anxiety disorders remains elevated following individual therapy: a randomized clinical trial

2018 ◽  
Vol 59 (11) ◽  
pp. 1152-1161 ◽  
Author(s):  
Cecile D. Ladouceur ◽  
Patricia Z. Tan ◽  
Vinod Sharma ◽  
Lauren M. Bylsma ◽  
Jennifer S. Silk ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Anxiety Disorders ◽  
Randomized Clinical Trial ◽  
Brain Activity ◽  
Individual Therapy ◽  
Pediatric Anxiety ◽  
Pediatric Anxiety Disorders

Integrating radiomics into clinical trial design

2019 ◽  
Vol 63 (4) ◽  
Author(s):  
Jessica J. Waninger ◽  
Michael D. Green ◽  
Catherine Cheze Le Rest ◽  
Benjamin Rosen ◽  
Issam El Naqa
Keyword(s):  
Clinical Trial ◽  
Trial Design ◽  
Clinical Trial Design
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