Applied Clinical Trials October 2016

October 2016 | Volume 25, Issue 10
Applied Clinical Trials Oct/Nov 2016
FDA and industry have agreed on a set of recommendations for revising the drug user fee program, which now sits before Congress as U.S. election nears.
The discussion on the main characteristics and implementation of the new Clinical Trials Regulation is heating up in Europe.
Survey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.
Updated guidance incorporates the use of a patient-reported outcomes questionnaire—which could enable more endpoints and greater patient stratification for COPD trials.
Q&A explores the evolution of community-based studies—and the related sample management, regulatory, compliance, and logistics support considerations.
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By Applied Clinical Trials Editors
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View from Brussels
New actions underway seek to find a consensus on the role of HTAs in the decision-making chain, including with clinical trials.
Clinical Trial Insights
New study finds that most biopharma companies are now using a standard set of key performance indicators.
Feature Article
Study collects first comprehensive metrics on current supply management and distribution practices.
An overview of clinical supply blinding methods in the context of the current research environment.
From basic blood draws to more involved samples, keeping accurate track and records is crucial for trials.
Using strategic planning to address hurdles in biosimilar development programs from the outset.
A Closing Thought
With cell-based therapies possessing multistep supply chains and complex track and trace, logistics management systems can be useful for trials even in the protocol-planning stage.
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