In our December/January issue:
PEER-REVIEWED ARTICLES
Performance Data: Public vs. Private
Claire Sears, PhD, Elisa Cascade
When accessing metrics to support study planning and predict site recruitment, authors investigate the potential difference between using mean calculated from public data only available at the study-level versus median calculated from site-level data from CTMS.
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Front-end Function Benchmarks
Mary Jo Lamberti, PhD, Ranjana Chakravarthy, Kenneth A. Getz
With sponsors and CROs looking for more efficient ways to streamline trial processes and accelerate study cycle times, this report—using results of a comprehensive survey— presents new benchmarks for the key trial initiation activities: site selection, study start-up, and site activation.
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RBM Model Roots?
Therese S. Geraci, Lillian Carroll, Connie Kingry, Janice M. Johnson, Debra Egan, Jeffrey L. Probstfield, MD, Sara M. Pressel, Linda B. Piller, MD
A look back at how one large academic clinical trial adopted a coordinating model for study oversight, with regional coordinators playing an integral part in what may have been a precursor to today's approaches in risk-based monitoring.
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Impact: Direct-to-Patient Contacts
Xavier Fournie, MD, Jean Siebenaler, MD, Sandra Wiederkehr, PhD
Authors explore the influence of patient-reported-data in determining whether a study is classified as interventional vs. non-interventional in the EU.
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NEWS
View From Washington: Jill Wechsler details the likely pharma R&D policy changes in store with new leadership on Capitol Hill.
View From Brussels: Peter O’Donnell reports on the latest maneuvering in the EU to land EMA residency post-Brexit.
Global Report: Philip Ward looks at the ICH's decision to revise key GCP guideline on trial oversight.
Data Analysis: Survey weighs industry opinion on big data's current role and future impact in drug development.
Clinical Technology: Q&A explores the value of big data today in harnessing unstructured and real-world data to boost research.
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CLINICAL TRIAL INSIGHTS
IRB-Site Relationship Repair
Ken Getz
New study finds that the long-strained relationship between sites and institutional review boards has shown signs of improving. |
CLOSING THOUGHT
Milestone for CDISC Standards
Barrie Nelson
Implementing CDISC data submission standards no longer just an industry best practice—but now an FDA requirement.
Updated CDISC Glossary
In its first published update since 2011, The CDISC Glossary Project Team has updated this resource and collaborates on the terms' most common usage in clinical research. The CDISC Glossary also includes references and links to other glossaries, such as regulatory dictionaries and health-related controlled terminologies useful in conducting clinical research.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - lisa.henderson@ubm.com
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