In Our May Digital Issue:
FEATURED
Data Integrity Amid Pandemic
Craig McLendon
Regulators are urging the use of data monitoring committees to support clinical trial management and decision-making during the COVID-19 outbreak.
RBQM in Action: A Case Study
Johann Proeve, PhD
A review of the effectiveness of one company’s training and educational program in helping to initiate rollout of risk-based quality management practices.
Bridging the Gaps in CAPA Planning
Linda B. Sullivan
Leveraging approaches in connecting RBQM and corrective and preventive action (CAPA) in clinical trials to enable real-time learning about existing risks, along with ongoing identification of emerging issues and potential threats.
The Central RBM Advantage
Sheelagh Aird
Implementing centralized risk-based monitoring can help sponsors meet strict GCP requirements for study conduct, oversight, and data recording and reporting.
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NEWS
Washington Report: Jill Wechsler on the concerns around coordinating multiple and potentially overlapping COVID R&D projects.
EU Report: Peter O’Donnell details the EMA’s push to speed up coronavirus research through information-sharing.
Q&A: Physician scientist-turned entrepreneur discusses the adoption of remote, decentralized, and virtual trials and the likely new landscape post-pandemic.
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FROM THE EDITOR
COVID Overload in Research
Lisa Henderson
With the onslaught of coronavirus-specific information, databases and trackers, registries, and other tools out there, the challenge in store is integrating these resources to aid clinical care response and drug intervention in real-time.
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CLOSING THOUGHT
New Evidence Methods Necessary
Ülo Palm, MD, PhD, Iya Khalil, PhD
As the current global crisis shows, there is an urgent need for statisticians, mathematicians, and computer and data scientists to collaborate on modern methods for “substantial evidence” generation in drug development.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lhenderson@mjhlifesciences.com
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