Tag: trial design
Inter-rater Reliability Assessment of ASPECT-R (A Study Pragmatic-Explanatory Characterization Tool-Rating)
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 […]
ASPECT-R—A Tool to Rate the Pragmatic and Explanatory Characteristics of a Clinical Trial Design
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, […]
Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders
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 […]
It’s Only a Little Ice: A Personal View with Companion Commentary
by Stephen G. Thein, PhD Dr. Thein is Director/Principal Investigator of Pacific Research Network, Inc., in San Diego, California. With companion commentary by Atul R. Mahableshwarkar, MD Dr. Mahableshwarkar is Senior Medical Director at Takeda Global Research & Development Center, Inc. in Deerfield, Illinois. Innov Clin Neurosci. 2012;9(2):21–25
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