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11 results on '"Roy, Dooti"'

1. Commentary: analyzing binary data using MCPMod when zero counts are expected

Author

Liu, Yi, Bossert, Sebastian, Wu, Rui, Roy, Dooti, Fleischer, Frank, and Deng, Qiqi

Subjects
Statistics - Methodology, Statistics - Applications
Abstract

Bretz et al (2005) proposed multiple Comparison Procedure and Modeling (MCPMod) method to design and analyze dose-finding study. Pinheiro (2014) then generalized it to various types of endpoint, including but not limited to binary endpoint, survival endpoint, count data, and longitudinal data. Pinheiro (2013) recommended to use the estimated covariance matrix from the observed data to recalculate the optimal contrast and the critical value of the test For many phase II studies it is common to have small sample sizes per arm with low placebo response rates jointly. Under such circumstances, it cannot be excluded to have a zero count observed. For example, when the placebo response rate is 10%, there is about 4% chance to observe zero responders in the placebo group, or other dose group(s), which has a similar response rate as placebo. In this manuscript, we would like to illustrate the potential problem of Pinheiro (2013) using a case study and simulations. An alternative method using Firth's logistic regression was evaluated to get a stable estimate of response for each dose group. In addition, we evaluated two options to address the issue with problematic contrast coefficients.

Published
2022

3. Best Practices for Collecting Gender and Sex Data

Author

Thornton, Suzanne, Roy, Dooti, Parry, Stephen, LaLonde, Donna, Martinez, Wendy, Ellis, Renee, and Corliss, David

Subjects
Statistics - Methodology, Statistics - Applications, 62-00 (Primary), 62-02 (Secondary), 62-11, 97K40, 97K70, 97K80, E.m, A.2
Abstract

The measurement and analysis of human sex and gender is a nuanced problem with many overlapping considerations including statistical bias, data privacy, and the ethical treatment of study subjects. Traditionally, human gender and sex have been categorized and measured with respect to an artificial binary system. The continuation of this tradition persists mainly because it is easy to replication and not, as we argue, because it produces the most valuable scientific information. Sex and gender identity data is crucial for many applications of statistical analysis and many modern scientists acknowledge the limitations of the current system. However, discrimination against sex and gender minorities poses very real privacy concerns when collecting and distributing gender and sex data. As such, extra thoughtfulness and care is essential to design safe and informative scientific studies. In this paper, we present statistically informed recommendations for the data collection and analysis of human subjects that not only respect each individual's identity and protect their privacy, but also establish standards for collecting higher quality data.

Published
2021

4. A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale

Author

Keefe, Richard SE, Woods, Scott W, Cannon, Tyrone D, Ruhrmann, Stephan, Mathalon, Daniel H, McGuire, Philip, Rosenbrock, Holger, Daniels, Kristen, Cotton, Daniel, Roy, Dooti, Pollentier, Stephane, and Sand, Michael

Subjects
Biological Psychology, Pharmacology and Pharmaceutical Sciences, Biomedical and Clinical Sciences, Psychology, Schizophrenia, Clinical Research, Brain Disorders, Serious Mental Illness, Prevention, Mental Health, Clinical Trials and Supportive Activities, Neurosciences, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Mental health, Clinical Trials, Phase II as Topic, Humans, Psychotic Disorders, Pyrazoles, Pyrimidines, Randomized Controlled Trials as Topic, cognition, early intervention, phosphodiesterase, psychotic disorders, schizophrenia, Clinical Sciences, Psychiatry, Clinical sciences, Clinical and health psychology
Abstract

AimAttenuated psychosis syndrome (APS), a condition for further study in the Diagnostic and Statistical Manual of Mental Disorders-5, comprises psychotic symptoms that are qualitatively similar to those observed in schizophrenia but are less severe. Patients with APS are at high risk of converting to first-episode psychosis (FEP). As evidence for effective pharmacological interventions in APS is limited, novel treatments may provide symptomatic relief and delay/prevent psychotic conversion. This trial aims to investigate the efficacy, safety, and tolerability of BI 409306, a potent and selective phosphodiesterase-9 inhibitor, versus placebo in APS. Novel biomarkers of psychosis are being investigated.MethodsIn this Phase II, multinational, double-blind, parallel-group trial, randomized (1:1) patients will receive BI 409306 50 mg or placebo twice daily for 52 weeks. Patients (n = 300) will be enrolled to determine time to remission of APS, time to FEP, change in everyday functional capacity (Schizophrenia Cognition Rating Scale), and change from baseline in Brief Assessment of Cognition composite score and Positive and Negative Syndrome Scale scores. Potential biomarkers of psychosis under investigation include functional measures of brain activity and automated speech analyses. Safety is being assessed throughout.ConclusionsThis trial will determine whether BI 409306 is superior to placebo in achieving sustainable remission of APS and improvements in cognition and functional capacity. These advances may provide evidence-based treatment options for symptomatic relief in APS. Furthermore, the study will assess the effect of BI 409306 on psychotic conversion and explore the identification of patients at risk for conversion using novel biomarkers.

Published
2021

9. Increasing JEDI in Clinical Trials.

Author

Yung, Godwin and Roy, Dooti

Subjects
*CLINICAL trials, *SOCIAL science research, *MEDICAL personnel, *BEHAVIORAL sciences
Published
2022

10. A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale

Author

Keefe, Richard S. E., Woods, Scott W., Cannon, Tyrone D., Ruhrmann, Stephan, Mathalon, Daniel H., McGuire, Philip, Rosenbrock, Holger, Daniels, Kristen, Cotton, Daniel, Roy, Dooti, Pollentier, Stephane, Sand, Michael, Keefe, Richard S. E., Woods, Scott W., Cannon, Tyrone D., Ruhrmann, Stephan, Mathalon, Daniel H., McGuire, Philip, Rosenbrock, Holger, Daniels, Kristen, Cotton, Daniel, Roy, Dooti, Pollentier, Stephane, and Sand, Michael

Abstract

Aim Attenuated psychosis syndrome (APS), a condition for further study in the Diagnostic and Statistical Manual of Mental Disorders-5, comprises psychotic symptoms that are qualitatively similar to those observed in schizophrenia but are less severe. Patients with APS are at high risk of converting to first-episode psychosis (FEP). As evidence for effective pharmacological interventions in APS is limited, novel treatments may provide symptomatic relief and delay/prevent psychotic conversion. This trial aims to investigate the efficacy, safety, and tolerability of BI 409306, a potent and selective phosphodiesterase-9 inhibitor, versus placebo in APS. Novel biomarkers of psychosis are being investigated. Methods In this Phase II, multinational, double-blind, parallel-group trial, randomized (1:1) patients will receive BI 409306 50 mg or placebo twice daily for 52 weeks. Patients (n = 300) will be enrolled to determine time to remission of APS, time to FEP, change in everyday functional capacity (Schizophrenia Cognition Rating Scale), and change from baseline in Brief Assessment of Cognition composite score and Positive and Negative Syndrome Scale scores. Potential biomarkers of psychosis under investigation include functional measures of brain activity and automated speech analyses. Safety is being assessed throughout. Conclusions This trial will determine whether BI 409306 is superior to placebo in achieving sustainable remission of APS and improvements in cognition and functional capacity. These advances may provide evidence-based treatment options for symptomatic relief in APS. Furthermore, the study will assess the effect of BI 409306 on psychotic conversion and explore the identification of patients at risk for conversion using novel biomarkers.

11. A randomized Phase II trial evaluating efficacy, safety, and tolerability of oral BI 409306 in attenuated psychosis syndrome: Design and rationale

Author

Keefe, Richard S. E., Woods, Scott W., Cannon, Tyrone D., Ruhrmann, Stephan, Mathalon, Daniel H., McGuire, Philip, Rosenbrock, Holger, Daniels, Kristen, Cotton, Daniel, Roy, Dooti, Pollentier, Stephane, Sand, Michael, Keefe, Richard S. E., Woods, Scott W., Cannon, Tyrone D., Ruhrmann, Stephan, Mathalon, Daniel H., McGuire, Philip, Rosenbrock, Holger, Daniels, Kristen, Cotton, Daniel, Roy, Dooti, Pollentier, Stephane, and Sand, Michael

Abstract

Aim Attenuated psychosis syndrome (APS), a condition for further study in the Diagnostic and Statistical Manual of Mental Disorders-5, comprises psychotic symptoms that are qualitatively similar to those observed in schizophrenia but are less severe. Patients with APS are at high risk of converting to first-episode psychosis (FEP). As evidence for effective pharmacological interventions in APS is limited, novel treatments may provide symptomatic relief and delay/prevent psychotic conversion. This trial aims to investigate the efficacy, safety, and tolerability of BI 409306, a potent and selective phosphodiesterase-9 inhibitor, versus placebo in APS. Novel biomarkers of psychosis are being investigated. Methods In this Phase II, multinational, double-blind, parallel-group trial, randomized (1:1) patients will receive BI 409306 50 mg or placebo twice daily for 52 weeks. Patients (n = 300) will be enrolled to determine time to remission of APS, time to FEP, change in everyday functional capacity (Schizophrenia Cognition Rating Scale), and change from baseline in Brief Assessment of Cognition composite score and Positive and Negative Syndrome Scale scores. Potential biomarkers of psychosis under investigation include functional measures of brain activity and automated speech analyses. Safety is being assessed throughout. Conclusions This trial will determine whether BI 409306 is superior to placebo in achieving sustainable remission of APS and improvements in cognition and functional capacity. These advances may provide evidence-based treatment options for symptomatic relief in APS. Furthermore, the study will assess the effect of BI 409306 on psychotic conversion and explore the identification of patients at risk for conversion using novel biomarkers.

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