Tag: trial design

Inter-rater Reliability Assessment of ASPECT-R (A Study Pragmatic-Explanatory Characterization Tool-Rating)

Inter-rater Reliability Assessment of ASPECT-R (A Study Pragmatic-Explanatory Characterization Tool-Rating)

| April 1, 2016 | 0 Comments

by Cynthia A. Bossie, PhD; Larry D. Alphs, MD, PhD; David Williamson, PhD; Lian Mao, PhD; Clennon Kurut, BS; and the ASPECT-R Rater Team Drs. Bossie, Alphs, and Williamson are with Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA; Dr. Mao and Mr. Kurut are with Janssen Research & Development, Titusville, New Jersey, USA Innov […]

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ASPECT-R—A Tool to Rate the Pragmatic and Explanatory Characteristics of a Clinical Trial Design

ASPECT-R—A Tool to Rate the Pragmatic and Explanatory Characteristics of a Clinical Trial Design

| February 1, 2016 | 0 Comments

by Larry D. Alphs, MD, PhD, and Cynthia A. Bossie, PhD Drs. Alphs and Bossie are with Janssen Scientific Affairs, LLC, Titusville, New Jersey, USA. Innov Clin Neurosci. 2016;13(1–2):15–26 Funding: Financial support provided by Janssen Scientific Affairs, LLC. Financial Disclosures: Drs. Alphs and Bossie are full-time employees of Janssen Scientific Affairs, LLC. Key Words: ASPECT-R, […]

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Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders

| February 1, 2016 | 2 Comments

by the CNS SUMMIT DATA QUALITY MONITORING WORKGROUP CORE MEMBERS—David Daniel, MD; Amir Kalali, MD; Mark West; David Walling, PhD; Dana Hilt, MD; Nina Engelhardt, PhD; Larry Alphs, MD, PhD; Antony Loebel, MD; Kim Vanover, PhD; Sarah Atkinson, MD; Mark Opler, PhD, MPH; Gary Sachs, MD; Kari Nations, PhD; and Chris Brady, PsyD Dr. Daniel […]

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