Applied Clinical Trials April 2016

April 2016 | Volume 25, Issue 4
News
FDA's new commissioner advocates for a "learning healthcare system" and less-complex clinical trial models that tap efficiencies in study design and enrollment.
The agency is concerned about the lack of non-clinical models with good predictive properties in the oncology space.
Trend doesn't seem to fall in line with the perception of an increasingly complex trial protocol climate.
View from Brussels
New policy hopes to calm the fervor around clinical trial data disclosure and confidentiality issues.
Clinical Trial Insights
Study provides real metrics on the trial-scope effects of protocol changes—shedding fresh light on the importance of adopting new strategies to reduce select amendments.
Feature Article
Pediatric trials now feature increased modeling and analytics for safer drug dosing and response.
How to integrate evidence-based planning and real-world evidence to boost clinical trial productivity.
How to meet the rigorous safety and efficacy demands critical to evaluating newer targeted cancer therapies.
The smaller biopharmaceutical company perspective on mastering oncology immunotherapy clinical trials.
A Closing Thought
For programs such as the Precision Medicine Initiative’s Cancer MoonShot to have a chance at success, following a set of key technology mandates will be critical.
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