In our July/August issue:
FEATURED
The Pulse of Global Trials
Results of a new survey report, coupled with recent research, highlight current views on the globalization of clinical trials, including the biggest challenges in conducting multi-regional studies and setting standards in emerging markets.
PEER-REVIEWED ARTICLES
Layperson Trial Summaries: Key Considerations
M. Zaninelli, E. Ornago, E. Sala, PhD, A. Ferrari, MD, PhD
Authors present the framework and information structure for writing layperson summaries of clinical trial results in Europe—and propose a “reader-centered” approach to constructing these summaries.
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Boosting Enrollment Efficiency
Paul Savuto, Jeffrey DuBois, Steve Karuppan
More effective screening procedures can help rule out subjects during the first enrollment visit and, thus, shorten timelines and reduce costs of central lab testing. This retrospective analysis of clinical trial enrollment data evaluates the effectiveness of point-of-care testing in reducing later-screen failures.
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NEWS
Washington Report: Jill Wechsler on FDA's increasing flexibility in approving drugs with unconventional development paths.
EU Report: Peter O'Donnell details new and ambitious effort in Europe to harmonize unstructured health data.
Global Report: Philip Ward examines the growing pressure on clinical trial teams to involve more pregnant women in research.
Q&A: Partnership focuses on important task of tapping physicians for non-interventional research, such as observational studies.
Q&A: Exploring the true definition of patient centricity in clinical trials and how industry can better understand the concept.
Clinical Technology: A look at new FDA health IT initiatives in effort to simplify submission process.
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CLINICAL TRIAL INSIGHTS
Outsourcing’s Changing World
Ken Getz
With continued consolidation and acquisition activity, the contract clinical services landscape is undergoing major change—one that signals a drug development enterprise in profound transition. |
CLOSING THOUGHT
The Missing Productivity Opportunity
Cliff Culver
As industry headlines buzz with drug pricing uncertainty and M&A speculation, sponsors can boost productivity on the R&D front through more conscious management of outsourcing spend.
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If you would like to submit an article to Applied Clinical Trials, contact Lisa Henderson, Editorial Director - [email protected]
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