Applied Clinical Trials December 2016

December 2016 | Volume 25, Issue 12
Applied Clinical Trials December/January 2017
Glossary
By Applied Clinical Trials Editors
In its first published update since 2011, the CDISC Glossary Project Team has updated this resource, which includes hundreds of definitions for key terminology related to clinical research.
News
With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.
The Council adopts revision encouraging sponsors to implement improved oversight and management of clinical trials.
Survey collects thoughts from industry professionals on the current and future impact of big data in clinical trials.
By Applied Clinical Trials Editors
Q&A looks at the growing use of unstructured data in drug development and the evolving role of the clinical data manager amid the advent of real-world data as a research aid.
View from Brussels
With bidding starting to intensify among member states, several factors will determine the EMA’s next home.
Clinical Trial Insights
New study finds that the long-strained relationship between sites and institutional review boards may finally be improving.
Feature Article
Comparing mean vs. median to uncover the full data picture of site-level performance.
Assessing practices and inefficiencies with site selection, study start-up, and site activation.
How one large academic trial adopted a coordinating center model—helping drive early-model RBM gains
Examining interventional vs. non-interventional clinical study classification in the EU.
A Closing Thought
For those still waiting, the time is now to get compliant on FDA's new data submission requirement.
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